Clinical trial • Phase III • Nephrology | Rare Disease
SPARSENTAN for IgA nephropathy
Phase III trial of SPARSENTAN for IgA nephropathy.
Overview
- Trial Therapeutic Area
- Nephrology | Rare Disease
- Trial Disease
- IgA nephropathy
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 29-07-2024
- First CTIS Authorization Date
- 26-08-2024
Trial design
Randomised, open-label, irbesartan (arb comparator; product listed as irbesartan, oral tablets; product record indicates max daily dose amount 300 mg; over-encapsulated irbesartan used as the active-control comparator). Phase III trial in Croatia, Germany, Portugal and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Irbesartan (ARB comparator; product listed as IRBESARTAN, oral tablets; product record indicates max daily dose amount 300 mg; over-encapsulated irbesartan used as the active-control comparator).
- Target Sample Size
- 241
- Trial Duration For Participant
- 798
Eligibility
Recruits 241 Vulnerable population flag selected. Participants are adults (≥18 years) and must provide signed informed consent; for the open-label extension a signed informed consent for that period is also required. Women of childbearing potential must comply with specified contraception requirements. Multiple language ICFs and specific consent forms (including SMS/email consent variants and pregnancy/partner ICFs) are provided; no paediatric assent procedures are specified..
- Pregnancy Exclusion
- Double-Blind Period: Female patient is pregnant, breastfeeding or planning to conceive during the study.
- Vulnerable Population
- Vulnerable population flag selected. Participants are adults (≥18 years) and must provide signed informed consent; for the open-label extension a signed informed consent for that period is also required. Women of childbearing potential must comply with specified contraception requirements. Multiple language ICFs and specific consent forms (including SMS/email consent variants and pregnancy/partner ICFs) are provided; no paediatric assent procedures are specified.
Inclusion criteria
- {"criterion_text":"- Double-Blind Period: Male or female, aged ≥18 years.\n- Open-Label Extension Period: The patient did not permanently discontinue study medication during the double-blind period.\n- Open-Label Extension Period: WOCBP, beginning at menarche, must agree to the use of 1 highly reliable (ie, can achieve a failure rate of <1% per year) method of contraception from 7 days prior to the first dose of study medication until 90 days after the last dose of study medication (including open-label sparsentan). One additional barrier method must also be used during sexual activity, such as a diaphragm or diaphragm with spermicide (preferred), or male partner's use of male condom or male condom with spermicide (preferred), from the Week 114 visit until 90 days after the last dose of study medication.\n- Sparsentan + SGLT2 Inhibitor Sub-study: Based on assessments at a regularly scheduled open-label extension visit, a patient must meet all of the following criteria to be eligible for the Sub-study: The patient is participating in the open-label extension and is willing and able to provide signed informed consent for participation in the open-label extension period Sub-study.\n- Sparsentan + SGLT2 Inhibitor Sub-study: The patient has a urine protein excretion value of ≥0.3 g/day.\n- Sparsentan + SGLT2 Inhibitor Sub-study: The patient has an eGFR of ≥25 mL/min/1.73m2.\n- Sparsentan + SGLT2 Inhibitor Sub-study: The patient is on a stable dose of sparsentan for ≥8 weeks in the open-label extension period that is the maximum tolerated dose.\n- Sparsentan + SGLT2 Inhibitor Sub-study: The patient has ≥12 weeks of the study remaining.\n- Sparsentan + SGLT2 Inhibitor Sub-study: The patient fulfils local requirements, recommendations and does not have contraindications for on-label prescription of dapagliflozin.\n- Double-Blind Period: Biopsy-proven IgAN.\n- Double-Blind Period: Urine protein excretion value ≥1.0 g/day at screening.\n- Double-Blind Period: eGFR value of ≥30 mL/min/1.73 m2 at screening.\n- Double-Blind Period: The patient has been on a stable dose of ACEI and/or ARB therapy for at least 12 weeks prior to screening.\n- Double-Blind Period: At screening, systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤100 mmHg.\n- Double-Blind Period: Women of childbearing potential (WOCBP) must agree to the use of two forms of contraception.\n- Open-Label Extension Period: Based on assessments at the Week 110 and Week 114 visit, a patient must meet all of the following criteria to be eligible for the open-label extension period. The patient completed participation in the double-blind period, including the Week 114 visit.\n- Open-Label Extension Period: The patient is willing and able to provide signed informed consent for participation in the open-label extension period."}
Exclusion criteria
- {"criterion_text":"- Double-Blind Period: IgAN secondary to another condition.\n- Double-Blind Period: History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years.\n- Double-Blind Period: A screening hematocrit value <27% (0.27 Volume/Volume) or hemoglobin value <9 g/dL (90 g/L).\n- Double-Blind Period: A screening potassium value of >5.5 mEq/L (5.5 mmol/L).\n- Double-Blind Period: Female patient is pregnant, breastfeeding or planning to conceive during the study.\n- Double-Blind Period: Participation in a study of another investigational product within 28 days prior to screening.\n- Open-Label Extension Period: Based on assessments at the Week 110 and Week 114 visits, a patient who meets any of the following criteria will be excluded from the open-label extension period: The patient has progressed to end-stage renal disease (ESRD) requiring renal replacement therapy (RRT).\n- Open-Label Extension Period: The patient developed any criteria for discontinuation of study medication or discontinuation from the study, respectively, between Week 110 and Week 114.\n- Open-Label Extension Period: The patient was unable to initiate, or developed contraindications to, treatment with RAAS inhibitors between Week 110 and Week 114.\n- Open-Label Extension Period: The patient has an eGFR value of ≤20 mL/min/1.73 m2 at Week 110.\n- Open-Label Extension Period: The patient has a potassium value of >5.5 mEq/L (5.5 mmol/L).\n- Double-Blind Period: Cellular glomerular crescents present in >25% of glomeruli on renal biopsy within 6 months prior to screening.\n- Open-Label Extension Period: The female patient is pregnant or is breastfeeding.\n- Sparsentan + SGLT2 inhibitor Sub-study: Based on assessments at an open-label extension visit, a patient who meets any of the following criteria will be excluded from participation in the open-label extension period Sub-study: The patient has progressed to ESRD requiring RRT.\n- Sparsentan + SGLT2 inhibitor Sub-study: The patient has initiated or changed dose of a systemic immunosuppressive medication (including systemic steroids) within 12 weeks.\n- Sparsentan + SGLT2 inhibitor Sub-study: The patient has been taking an SGLT2 inhibitor within 12 weeks.\n- Sparsentan + SGLT2 inhibitor Sub-study: The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the Sub-study.\n- Double-Blind Period: The patient has a chronic kidney disease in addition to IgAN.\n- Double-Blind Period: Any organ transplantation, with the exception of corneal transplants.\n- Double-Blind Period: Treatment with any of the prohibited concomitant medications.\n- Double-Blind Period: Treatment with any systemic immunosuppressive medications (including corticosteroids) for >2 weeks within 3 months prior to screening\n- Double-Blind Period: Documented history of heart failure and/or previous hospitalization for heart failure or unexplained dyspnea, orthopnea, paroxysmal nocturnal dyspnea, ascites, and/or peripheral edema.\n- Double-Blind Period: Clinically significant cerebrovascular disease and/or coronary artery disease.\n- Double-Blind Period: Jaundice, hepatitis, or known hepatobiliary disease (excluding asymptomatic cholelithiasis), or transaminase levels >2 times the upper limit of the normal range at screening."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Efficacy End points: The primary efficacy endpoint is the change from baseline in the urine protein/creatinine ratio (UP/C) at Week 36.\n- Safety End points: Descriptive statistics will be used to summarize the safety data. All safety evaluations will be conducted based on the Safety Analysis Set. Observed data will be listed by patient.\n- Open-Label Extension Period: Endpoints for the open-label extension period include, but are not necessarily limited to: The absolute and percent change from Week 114 in eGFR at each visit\n- Open-Label Extension Period: The percent change from Week 114 in UP/C at each visit\n- Open-Label Extension Period: Changes from Week 114 in QoL at each visit\n- Open-Label Extension Period: Changes from Week 114 in body weight, vital signs, physical examinations, peripheral edema, and clinical laboratory parameters\n- Open-Label Extension Period: Changes from Week 114 in lipid profile (total cholesterol and triglycerides, low density lipoprotein C, and high density lipoprotein C)\n- Open-Label Extension Period: The incidence of TEAEs during the open-label extension period\n- Sparsentan + SGLT2 Inhibitor Sub-study: For the Sub-study, the baseline visit (Day 1) is defined as the visit upon which eligibility is assessed. Safety Endpoints: Safety evaluations include the following: Changes from Sub-study baseline in body weight, vital signs, physical examinations, peripheral edema, and clinical laboratory parameters at each visit.\n- Sparsentan + SGLT2 Inhibitor Sub-study: The incidence of TEAEs during the Sub-study period.\n- Sparsentan + SGLT2 Inhibitor Sub-study: Efficacy Endpoints: Endpoints include, but are not limited to: The mean change from Sub-study baseline in UP/C and UA/C based on a 24-hour urine sample at the next scheduled visit.\n- Sparsentan + SGLT2 Inhibitor Sub-study: Achievement of urinary protein excretion <0.3 g/day at the next scheduled visit.\n- Sparsentan + SGLT2 Inhibitor Sub-study: Change in absolute and percent change from Sub-study baseline in eGFR at the next scheduled visit.","definition_or_measurement_approach":"Primary efficacy: change from baseline in urine protein/creatinine ratio (UP/C) at Week 36 (measured from urine sample). Safety: descriptive statistics summarised using the Safety Analysis Set, observed data listed by patient. Open-label endpoints: changes from Week 114 in eGFR, UP/C, QoL, body weight, vital signs, peripheral edema, labs, and lipid profile at each visit; incidence of treatment-emergent adverse events (TEAEs). Sub-study endpoints: changes from sub-study baseline (Day 1) in UP/C and UA/C based on 24-hour urine sample; achievement of urinary protein excretion <0.3 g/day; safety changes from baseline in vitals, exams, labs; incidence of TEAEs."}
Secondary endpoints
- {"endpoint_text":"- Rate of change of eGFR","definition_or_measurement_approach":"Rate of change in estimated glomerular filtration rate (eGFR) over time (measurement approach not further specified in the record)."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 241
- Recruitment Window Months
- 89
- Consent Approach
- Signed informed consent required from each participant (participants are adults ≥18 years). For the open-label extension, separate signed informed consent for that period is required. Women of childbearing potential must agree to specific contraception regimens. Multiple language ICFs and specific consent variants are provided (including SMS/email consent forms and sub-study/pregnancy/partner ICFs), indicating consent materials are available in local languages and remote consent options are provided.
Methods
- Site-based recruitment through participating hospitals/clinics at listed trial sites in each country (site lists provided in Part II).
- Patient recruitment activities by IQVIA Limited (role explicitly listed as 'Patient recruitment').
- Public/sponsor contact available via Travere Call Center (medinfo@travere.com) for information.
Geography
- Total Number Of Sites
- 54
- Total Number Of Participants
- 162
Croatia
- Earliest CTIS Part Ii Submission Date
- 27-08-2024
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 588
- Number Of Sites
- 6
- Number Of Participants
- 11
Sites
- Site Name
- Poliklinika Dr. Ivan Drinkovic
- Department Name
- Department of Internal Medicine and Nephrology
- Principal Investigator Name
- Ingrid Prkacin
- Principal Investigator Email
- ingrid.prkacin@gmail.com
- Contact Person Name
- Ingrid Prkacin
- Contact Person Email
- ingrid.prkacin@gmail.com
- Site Name
- Poliklinika Solmed d.o.o.
- Department Name
- Department of Nephrology and Dialysis
- Principal Investigator Name
- Drasko Pavlovic
- Principal Investigator Email
- drasko.pavlovic@solmed-clinic.com
- Contact Person Name
- Drasko Pavlovic
- Contact Person Email
- drasko.pavlovic@solmed-clinic.com
- Site Name
- University Hospital Sveti Duh
- Department Name
- Department of Nephrology and Dialysis
- Principal Investigator Name
- Ivana Mikacic
- Principal Investigator Email
- mikacicivana@yahoo.com
- Contact Person Name
- Ivana Mikacic
- Contact Person Email
- mikacicivana@yahoo.com
- Site Name
- Klinicki Bolnicki Centar Osijek
- Department Name
- Department of Nephrology
- Principal Investigator Name
- Jerko Barbic
- Principal Investigator Email
- jbarbic@mefos.hr
- Contact Person Name
- Jerko Barbic
- Contact Person Email
- jbarbic@mefos.hr
- Site Name
- Clinical Hospital Dubrava
- Department Name
- Department of Nephrology and Dialysis
- Principal Investigator Name
- Ivan Durlen
- Principal Investigator Email
- durlenivan@gmail.com
- Contact Person Name
- Ivan Durlen
- Contact Person Email
- durlenivan@gmail.com
- Site Name
- University Hospital Centre Zagreb
- Department Name
- Department of nephrology, arterial hypertension, dialysis and transplantation
- Principal Investigator Name
- Bojan Jelakovic
- Principal Investigator Email
- jelakovicbojan@gmail.com
- Contact Person Name
- Bojan Jelakovic
- Contact Person Email
- jelakovicbojan@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 08-04-2026
- Processing Time Days
- 588
- Number Of Sites
- 6
- Number Of Participants
- 16
Sites
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Medizinische Klinik II Klinik für Nieren und Hochdruckkrankheiten
- Principal Investigator Name
- Marcus Johannes Möller
- Principal Investigator Email
- mmoeller@ukaachen.de
- Contact Person Name
- Marcus Johannes Möller
- Contact Person Email
- mmoeller@ukaachen.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Klinik f. Innere Medizin III
- Principal Investigator Name
- Martin Busch
- Principal Investigator Email
- martin.busch@med.uni-jena.de
- Contact Person Name
- Martin Busch
- Contact Person Email
- martin.busch@med.uni-jena.de
- Site Name
- Zentrum Fuer Nieren Hochdruck Und Stoffwechselerkrankungen
- Department Name
- Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
- Principal Investigator Name
- Georg Schlieper
- Principal Investigator Email
- dr.schlieper@dialyse-hannover.de
- Contact Person Name
- Georg Schlieper
- Contact Person Email
- dr.schlieper@dialyse-hannover.de
- Site Name
- DaVita Clinical Research Deutschland GmbH
- Department Name
- DaVita Clinical Research
- Principal Investigator Name
- Thilo Krüger
- Principal Investigator Email
- thilo.krueger@davita.com
- Contact Person Name
- Thilo Krüger
- Contact Person Email
- thilo.krueger@davita.com
- Site Name
- Nephrologisches Zentrum Villingen-Schwenningen GbR
- Department Name
- Nephrologisches Zentrum Villingen-Schwenningen
- Principal Investigator Name
- Bernd Hohenstein
- Principal Investigator Email
- b.hohenstein@nzvs.de
- Contact Person Name
- Bernd Hohenstein
- Contact Person Email
- b.hohenstein@nzvs.de
- Site Name
- Barmherzige Brueder Trier gGmbH
- Department Name
- Klinik für Innere Medizin II
- Principal Investigator Name
- Stefan Weiner
- Principal Investigator Email
- s.weiner@bbtgruppe.de
- Contact Person Name
- Stefan Weiner
- Contact Person Email
- s.weiner@bbtgruppe.de
Portugal
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 587
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Unidade Local De Saude De Gaia/Espinho E.P.E.
- Principal Investigator Name
- João Fernandes
- Principal Investigator Email
- joao.fernandes@chvng.min-saude.pt
- Contact Person Name
- João Fernandes
- Contact Person Email
- joao.fernandes@chvng.min-saude.pt
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Principal Investigator Name
- Jorge Lopes
- Principal Investigator Email
- sofiacjorge@sapo.pt
- Contact Person Name
- Jorge Lopes
- Contact Person Email
- sofiacjorge@sapo.pt
- Site Name
- Unidade Local De Saude De Sao Jose E.P.E.
- Principal Investigator Name
- Fernando Nolasco
- Principal Investigator Email
- sec.adm.hcc@ulssjose.min-saude.pt
- Contact Person Name
- Fernando Nolasco
- Contact Person Email
- sec.adm.hcc@ulssjose.min-saude.pt
- Site Name
- Hospital Beatriz Angelo
- Principal Investigator Name
- Ana Cortesão Costa
- Principal Investigator Email
- anacortesaocosta@gmail.com
- Contact Person Name
- Ana Cortesão Costa
- Contact Person Email
- anacortesaocosta@gmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 30-08-2024
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 585
- Number Of Sites
- 2
- Number Of Participants
- 13
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Klinika nefrologie
- Principal Investigator Name
- Vladimír Tesař
- Principal Investigator Email
- vladimir.tesar@vfn.cz
- Contact Person Name
- Vladimír Tesař
- Contact Person Email
- vladimir.tesar@vfn.cz
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- Interní klinika
- Principal Investigator Name
- Ivan Rychlík
- Principal Investigator Email
- ivan.rychlik@fnkv.cz
- Contact Person Name
- Ivan Rychlík
- Contact Person Email
- ivan.rychlik@fnkv.cz
Italy
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 08-04-2026
- Processing Time Days
- 568
- Number Of Sites
- 7
- Number Of Participants
- 27
Sites
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Nephrology and Dialysis
- Principal Investigator Name
- Luigi Biancone
- Principal Investigator Email
- luigi.biancone@unito.it
- Contact Person Name
- Luigi Biancone
- Contact Person Email
- luigi.biancone@unito.it
- Site Name
- University Hospital Consorziale Policlinico
- Department Name
- C.O.U Nephrology, Dialysis and Transplantation
- Principal Investigator Name
- Loreto Gesualdo
- Principal Investigator Email
- loretogesualdo.trialid@gmail.com
- Contact Person Name
- Loreto Lopes
- Contact Person Email
- loretogesualdo.trialid@gmail.com
- Site Name
- Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione
- Department Name
- O.U. Nephrology and Hemodialysis
- Principal Investigator Name
- Ciro Esposito
- Principal Investigator Email
- ciro.esposito@icsmaugeri.it
- Contact Person Name
- Ciro Esposito
- Contact Person Email
- ciro.esposito@icsmaugeri.it
- Site Name
- Alessandro Manzoni Hospital
- Department Name
- Nephrology, Dialysis and Renal Transplantation
- Principal Investigator Name
- Selena Longhi
- Principal Investigator Email
- s.longhi@asst-lecco.it
- Contact Person Name
- Selena Longhi
- Contact Person Email
- s.longhi@asst-lecco.it
- Site Name
- Istituto Di Ricerche Farmacologiche Mario Negri
- Department Name
- Renal Medicine
- Principal Investigator Name
- Giuseppe Remuzzi
- Principal Investigator Email
- giuseppe.remuzzi@marionegri.it
- Contact Person Name
- Giuseppe Remuzzi
- Contact Person Email
- giuseppe.remuzzi@marionegri.it
- Site Name
- Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
- Department Name
- C.O.U. Nephrology and Dialysis
- Principal Investigator Name
- Mario Gennaro Cozzolino
- Principal Investigator Email
- mario.cozzolino@unimi.it
- Contact Person Name
- Mario Gennaro Cozzolino
- Contact Person Email
- mario.cozzolino@unimi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- C.O.U. Nephrology and Dialysis
- Principal Investigator Name
- Stefano Costanzi
- Principal Investigator Email
- stefano.costanzi@policlinicogemelli.it
- Contact Person Name
- Stefano Costanzi
- Contact Person Email
- stefano.costanzi@policlinicogemelli.it
Belgium
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 587
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- Campus Kennedylaan
- Principal Investigator Name
- Gert Meeus
- Principal Investigator Email
- gert.meeus@azgroeninge.be
- Contact Person Name
- Gert Meeus
- Contact Person Email
- gert.meeus@azgroeninge.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- nephrology
- Principal Investigator Name
- Bart Maes
- Principal Investigator Email
- art.maes@azdelta.be
- Contact Person Name
- Bart Maes
- Contact Person Email
- art.maes@azdelta.be
- Site Name
- Centre Hospitalier Regional De La Citadelle
- Department Name
- nephrology
- Principal Investigator Name
- Xavier Warling
- Principal Investigator Email
- xavier.warling@citadelle.be
- Contact Person Name
- Xavier Warling
- Contact Person Email
- xavier.warling@citadelle.be
- Site Name
- Az Sint-Lucas
- Department Name
- nephrology
- Principal Investigator Name
- Bert Vandewiele
- Principal Investigator Email
- bert.vandewiele@stlucas.be
- Contact Person Name
- Bert Vandewiele
- Contact Person Email
- bert.vandewiele@stlucas.be
Estonia
- Earliest CTIS Part Ii Submission Date
- 02-09-2024
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 582
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- North Estonia Medical Centre Foundation
- Principal Investigator Name
- Kadri Lilienthal
- Principal Investigator Email
- kadri.lilienthal@regionaalhaigla.ee
- Contact Person Name
- Kadri Lilienthal
- Contact Person Email
- kadri.lilienthal@regionaalhaigla.ee
- Site Name
- Laane-Tallinna Keskhaigla AS
- Principal Investigator Name
- Madis Ilmoja
- Principal Investigator Email
- madis.ilmoja@keskhaigla.ee
- Contact Person Name
- Madis Ilmoja
- Contact Person Email
- madis.ilmoja@keskhaigla.ee
- Site Name
- Tartu University Hospital
- Principal Investigator Name
- Mai Rosenberg
- Principal Investigator Email
- mai.rosenberg@kliinikum.ee
- Contact Person Name
- Mai Rosenberg
- Contact Person Email
- mai.rosenberg@kliinikum.ee
Lithuania
- Earliest CTIS Part Ii Submission Date
- 06-09-2024
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 578
- Number Of Sites
- 2
- Number Of Participants
- 11
Sites
- Site Name
- Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
- Department Name
- Center of Nephrology
- Principal Investigator Name
- Marius Miglinas
- Principal Investigator Email
- marius.miglinas@santa.lt
- Contact Person Name
- Marius Miglinas
- Contact Person Email
- marius.miglinas@santa.lt
- Site Name
- Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
- Department Name
- Nephrology clinic
- Principal Investigator Name
- Inga Arune Bumblyte
- Principal Investigator Email
- inga.bumblyte@kaunoklinikos.lt
- Contact Person Name
- Inga Arune Bumblyte
- Contact Person Email
- inga.bumblyte@kaunoklinikos.lt
Poland
- Earliest CTIS Part Ii Submission Date
- 30-08-2024
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 585
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Specjalistyczne Centrum Medyczne Elzbieta Czkwianianc Elamed Sp. j.
- Principal Investigator Name
- Marcin Tkaczyk
- Principal Investigator Email
- marcin.tkaczyk45@gmail.com
- Contact Person Name
- Marcin Tkaczyk
- Contact Person Email
- marcin.tkaczyk45@gmail.com
- Site Name
- Scm Sp. z o.o.
- Principal Investigator Name
- Władysław Sułowicz
- Principal Investigator Email
- wladsul@mp.pl
- Contact Person Name
- Władysław Sułowicz
- Contact Person Email
- wladsul@mp.pl
- Site Name
- Miedzyleski Szpital Specjalistyczny W Warszawie
- Department Name
- Oddział Nefrologiczny, Stacja Dializ
- Principal Investigator Name
- Robert Malecki
- Principal Investigator Email
- robert.malecki@aol.pl
- Contact Person Name
- Robert Malecki
- Contact Person Email
- robert.malecki@aol.pl
- Site Name
- Wojewodzki Szpital Specjalistyczny W Olsztynie
- Department Name
- Odział Kliniczny Nefreologiczny, Hipertensjologii i Chorob Wewnętrznych
- Principal Investigator Name
- Tomasz Stompór
- Principal Investigator Email
- stompin@mp.pl
- Contact Person Name
- Tomasz Stompór
- Contact Person Email
- stompin@mp.pl
France
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 586
- Number Of Sites
- 6
- Number Of Participants
- 13
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Nephrology
- Principal Investigator Name
- Alexandre KARRAS
- Principal Investigator Email
- alexandre.karras@egp.aphp.fr
- Contact Person Name
- Alexandre KARRAS
- Contact Person Email
- alexandre.karras@egp.aphp.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Nephrology
- Principal Investigator Name
- Pierre-Louis CARRON
- Principal Investigator Email
- PLCarron@chu-grenoble.fr
- Contact Person Name
- Pierre-Louis CARRON
- Contact Person Email
- PLCarron@chu-grenoble.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Nephrology-Kidney transplantation -Dialysis
- Principal Investigator Name
- Damien THIBAUDIN
- Principal Investigator Email
- damien.thibaudin@chu-st-etienne.fr
- Contact Person Name
- Damien THIBAUDIN
- Contact Person Email
- damien.thibaudin@chu-st-etienne.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Nephrology
- Principal Investigator Name
- Leila CHENINE
- Principal Investigator Email
- l-chenine@chu-montpellier.fr
- Contact Person Name
- Leila CHENINE
- Contact Person Email
- l-chenine@chu-montpellier.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Nephrology
- Principal Investigator Name
- Cyril GARROUSTE
- Principal Investigator Email
- cgarrouste@chu-clermontferrand.fr
- Contact Person Name
- Cyril GARROUSTE
- Contact Person Email
- cgarrouste@chu-clermontferrand.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Nephrology
- Principal Investigator Name
- Stéphane BURTEY
- Principal Investigator Email
- stephaneb@ap-hm.fr
- Contact Person Name
- Stéphane BURTEY
- Contact Person Email
- stephaneb@ap-hm.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 26-08-2024
- Latest Decision Or Authorization Date
- 08-04-2026
- Processing Time Days
- 590
- Number Of Sites
- 10
- Number Of Participants
- 30
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Nephrology
- Principal Investigator Name
- Alberto Ortiz Arduan
- Principal Investigator Email
- aortiz@fjd.es
- Contact Person Name
- Alberto Ortiz Arduan
- Contact Person Email
- aortiz@fjd.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Nephrology
- Principal Investigator Name
- Angel Manuel Sevillano Prieto
- Principal Investigator Email
- sevillano.am@gmail.com
- Contact Person Name
- Martin Busch
- Contact Person Email
- sevillano.am@gmail.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Nephrology
- Principal Investigator Name
- Mercedes Salgueira Lazo
- Principal Investigator Email
- mercedes.salgueira.sspa@juntadeandalucia.es
- Contact Person Name
- Mercedes Salgueira Lazo
- Contact Person Email
- mercedes.salgueira.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Dr Peset Aleixandre
- Department Name
- Nephrology
- Principal Investigator Name
- Ana Ávila Bernabeu
- Principal Investigator Email
- aaaavilab@gmail.com
- Contact Person Name
- Ana Ávila Bernabeu
- Contact Person Email
- aaaavilab@gmail.com
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Nephrology
- Principal Investigator Name
- Eduardo Parra Moncasi
- Principal Investigator Email
- eparra@salud.aragon.es
- Contact Person Name
- Eduardo Parra Moncasi
- Contact Person Email
- eparra@salud.aragon.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Nephrology
- Principal Investigator Name
- Maria Angeles Goicoechea Diezhandino
- Principal Investigator Email
- marian.goicoechea@gmail.com
- Contact Person Name
- Maria Angeles Goicoechea Diezhandino
- Contact Person Email
- marian.goicoechea@gmail.com
- Site Name
- Hospital De Sagunto
- Department Name
- Internal Medicine
- Principal Investigator Name
- Tamara Gelen Malek Marin
- Principal Investigator Email
- tamaramalek@gmail.com
- Contact Person Name
- Tamara Gelen Malek Marin
- Contact Person Email
- tamaramalek@gmail.com
- Site Name
- Fundacio Puigvert
- Department Name
- Nephrology
- Principal Investigator Name
- Montserrat Mercedes Diaz Encarnacion
- Principal Investigator Email
- mmdiaz@fundacio-puigvert.es
- Contact Person Name
- Montserrat Mercedes Diaz Encarnacion
- Contact Person Email
- mmdiaz@fundacio-puigvert.es
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Nephrology
- Principal Investigator Name
- Marta Calvo Arevalo
- Principal Investigator Email
- calvoarevalo@gmail.com
- Contact Person Name
- Marta Calvo Arevalo
- Contact Person Email
- calvoarevalo@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Nephrology
- Principal Investigator Name
- Irene Agraz Pamplona
- Principal Investigator Email
- irene.agraz@vallhebron.cat
- Contact Person Name
- Irene Agraz Pamplona
- Contact Person Email
- irene.agraz@vallhebron.cat
Sponsor
Primary sponsor
- Full Name
- Travere Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- 4g Clinical LLC
- Responsibilities
- IRT for Treatment randomisation
- Name
- Medidata Solutions Inc.
- Responsibilities
- RAVE EDC (electronic data capture)
- Name
- IQVIA Limited
- Responsibilities
- Patient recruitment and multiple trial operational roles
- Name
- George Clinical Pty Limited
- Responsibilities
- Study management in the Asia Pacific region
- Name
- IQVIA Laboratories LLC / Iqvia Laboratories Limited
- Responsibilities
- Central laboratory services, sample storage and PK sample testing
- Name
- Catalent Pharma Solutions LLC
- Responsibilities
- Study drug packaging, labelling and depot services
Third parties
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"IRT for Treatment randomisation","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"RAVE EDC","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Multiple trial activities including patient recruitment, data management and other study support functions (roles listed in CTIS: codes include 1,2,4,5,6,8,9,11,12,15; 'Patient recruitment' explicitly listed).","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Catalent Pharma Solutions LLC","duties_or_roles":"Study Drug (Sparsentan and Irbesartan), Study Drug Labelling, Packaging and Depot","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"IQVIA Laboratories LLC","duties_or_roles":"Central Laboratory and sample storage; PK Sample Testing","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"India","full_name":"Qinecsa Solutions India Private Limited","duties_or_roles":"Safety Surveillance","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Australia","full_name":"George Clinical Pty Limited","duties_or_roles":"Study Management in the Asia Pacific Region and regional study support","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ePRO (Quality of Life Questionnaire Device)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Payments","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"Central Laboratory and sample storage","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Sparsentan_DF2
- Active Substance
- SPARSENTAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Orphan Designation
- Yes
- Maximum Dose
- 400 mg (maxDailyDoseAmount)
- Investigational Product Name
- Sparsentan_DF3
- Active Substance
- SPARSENTAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Orphan Designation
- Yes
- Maximum Dose
- 400 mg (maxDailyDoseAmount)
- Investigational Product Name
- IRBESARTAN
- Active Substance
- IRBESARTAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Maximum Dose
- 300 mg (maxDailyDoseAmount)
- Investigational Product Name
- DAPAGLIFLOZIN
- Active Substance
- DAPAGLIFLOZIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Maximum Dose
- 10 mg (maxDailyDoseAmount)
- Combination Treatment
- Yes
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