Clinical trial • Phase III • Nephrology

Dapagliflozin; Zibotentan for Chronic kidney disease with high proteinuria | IgA nephropathy (biopsy-confirmed subgroup)

Phase III trial of Dapagliflozin; Zibotentan for Chronic kidney disease with high proteinuria | IgA nephropathy (biopsy-confirmed subgroup).

Overview

Trial Therapeutic Area
Nephrology
Trial Disease
Chronic kidney disease with high proteinuria | IgA nephropathy (biopsy-confirmed subgroup)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
10-11-2023
First CTIS Authorization Date
18-03-2024

Trial design

Randomised, dapagliflozin (oral; dose not specified in provided documents) as comparator arm (dapagliflozin alone).-controlled Phase III trial in Netherlands, Spain, Sweden and others.

Randomised
Yes
Comparator
Dapagliflozin (oral; dose not specified in provided documents) as comparator arm (Dapagliflozin alone).
Target Sample Size
1505
Trial Duration For Participant
730

Eligibility

Recruits 1505 Vulnerable population flag selected. Participants must be ≥ 18 years and capable of giving signed informed consent; signed informed consent is required prior to any study-specific procedure. Electronic informed consent is used prior to completion of the optional Study Participant Feedback Questionnaire (SPFQ). Separate signed and dated written consent is required for optional genomics research (Optional Genomics Initiative Research Information and Consent Form)..

Pregnancy Exclusion
All female participants must have a negative serum pregnancy test result at screening (unless participants meet inclusion criterion 4a for being of not childbearing potential.)
Vulnerable Population
Vulnerable population flag selected. Participants must be ≥ 18 years and capable of giving signed informed consent; signed informed consent is required prior to any study-specific procedure. Electronic informed consent is used prior to completion of the optional Study Participant Feedback Questionnaire (SPFQ). Separate signed and dated written consent is required for optional genomics research (Optional Genomics Initiative Research Information and Consent Form).

Inclusion criteria

  • {"criterion_text":"-1.Participant must be ≥ 18 years of age and of legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent."}
  • {"criterion_text":"-2.Diagnosis of CKD, with eGFR ≥ 20 and < 90 mL/min/1.73 m2 and UACR > 700 mg/g (> 79 mg/mmol) or UPCR > 1000 mg/g (> 113mg/mmoL)."}
  • {"criterion_text":"-3.All female participants must have a negative serum pregnancy test result at screening (unless participants meet inclusion criterion 4a for being of not childbearing potential.)"}
  • {"criterion_text":"-4. Female participants must be either - not of child-bearing potential or - WOCBP using at least one highly effective birth control method for at least 3 months prior to first dose of study intervention"}
  • {"criterion_text":"-5. Capable of giving signed informed consent"}
  • {"criterion_text":"-6. Provision of signed informed consent prior to any study specific procedure."}
  • {"criterion_text":"-7. Provision of electronic informed consent prior to completion of the optional Study Participant Feedback Questionnaire (SPFQ)."}
  • {"criterion_text":"-8. Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form prior to collection of samples for optional genomics imitative research that supports the Genomic Initiative 5."}
  • {"criterion_text":"-9.Receiving RAASi therapy (ACEi or ARB), and for the patient maximum tolerated labelled daily dose, that has been stable for at least 4 weeks."}

Exclusion criteria

  • {"criterion_text":"-1.Participants with NYHA class III or class IV Congestive HF at the time of enrolment."}
  • {"criterion_text":"-10. History or ongoing allergy/hypersensitivity, as judged by the Investigator, to SGLT2i therapy (eg, dapagliflozin, canagliflozin, empagliflozin or other SGLT2 inhibitors) or Endothelin Receptor Antagonists (eg, ambrisentan, atrasentan, bosentan, or other) or any of the excipients of the products."}
  • {"criterion_text":"-11. Any condition with a life expectancy of less than 2 years based on investigator´s clinical judgment"}
  • {"criterion_text":"-12. Malignancy within the past 5 years. Exceptions to this criterion include non-melanoma skin cancer and curatively treated cervical carcinoma in situ"}
  • {"criterion_text":"-13. Significant liver disease as judged by the investigator or severe hepatic impairment with AST or ALT > 3 × ULN; or total bilirubin > 2 × ULN at time of screening. An isolated increase in bilirubin in participants with known Gilbert's syndrome is not a reason for exclusion"}
  • {"criterion_text":"-14. Known blood-borne diseases."}
  • {"criterion_text":"-15. Clinically significant, unstable, or uncontrolled medical condition as assessed by the Investigator."}
  • {"criterion_text":"-16. Participants on renal replacement therapy or previous kidney transplant."}
  • {"criterion_text":"-17. Known history of drug or alcohol abuse within 12 months of screening."}
  • {"criterion_text":"-18. Participants on treatment with strong or moderate CYP3A4 inducer."}
  • {"criterion_text":"-19.Participants on systemic immunosuppression therapy other than stable maintenance therapy defined as prednisone 10 mg/day (or equivalent) or less, aziothioprine 100 mg/day or less; MMF 1000 mg/day or less for at least 3 months prior to Visit 1. Inhaled, nasal or dermatological steroids are also allowed."}
  • {"criterion_text":"-2. Participants hospitalised for HF during the last 6 month prior to screening."}
  • {"criterion_text":"-20.Participants treated or expecting to be treated with tolvaptan, any other ERAs, or budesonide (where used to treat IBD or IgAN)."}
  • {"criterion_text":"-21. Participation in another clinical study with a study intervention administered in the last 3 months."}
  • {"criterion_text":"-3. Evidence of rales or jugular venous distention on physical examination"}
  • {"criterion_text":"-4. Participants with T1DM."}
  • {"criterion_text":"-5. History of any life-threatening ventricular dysrhythmia (continuous or paroxysmal)."}
  • {"criterion_text":"-6. Blood pressure above 160 mmHg systolic."}
  • {"criterion_text":"-7. Blood pressure below 90 mmHg systolic"}
  • {"criterion_text":"-8. Participants hospitalised for heart disease or cardiac procedures or for COVID-19 during the last 3 months prior to screening."}
  • {"criterion_text":"-9. History of solid organ transplantation or bone marrow transplant."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Change in eGFR from baseline to Month 24","definition_or_measurement_approach":"Change in estimated glomerular filtration rate (eGFR) measured from baseline to Month 24."}

Secondary endpoints

  • {"endpoint_text":"-1. Change from baseline in UACR","definition_or_measurement_approach":"Change from baseline in urine albumin-to-creatinine ratio (UACR)."}
  • {"endpoint_text":"-2. Time to the first occurrence of any of the components of the renal composite endpoint of 40% sustained decline in eGFR or ESKD or renal death","definition_or_measurement_approach":"Time-to-event analysis: time until first occurrence of a composite renal endpoint defined as 40% sustained decline in eGFR, end-stage kidney disease (ESKD), or renal death."}
  • {"endpoint_text":"-3. Change from baseline to UPCR","definition_or_measurement_approach":"Change from baseline in urine protein-to-creatinine ratio (UPCR)."}

Recruitment

Planned Sample Size
1505
Recruitment Window Months
44
Consent Approach
Adults (≥18) provide signed written informed consent prior to any study procedures. Electronic informed consent is used prior to completion of the optional Study Participant Feedback Questionnaire (SPFQ). Separate signed and dated written consent is required for optional genomics research. Subject information and ICF documents and local addenda (including WOCBP, genetic, future research addenda) are provided in country/local versions as submitted.

Methods

  • Recruitment arrangements documents submitted (K1 recruitment arrangements) — country-specific recruitment arrangements files are present for multiple countries (e.g., Germany, Austria, Norway, France, Poland, Denmark, Slovakia, Sweden, Italy, Spain).
  • Printed recruitment materials: posters (K2_Recruitment Material_Poster) — patient-targeted posters are present in the submission package for multiple countries.
  • Printed recruitment materials: patient pamphlets/leaflets (K2_Recruitment Material_Patient Pamphlet / Pamphlet) — patient-targeted pamphlets are present for multiple countries.

Geography

Total Number Of Sites
78
Total Number Of Participants
328

Netherlands

Earliest CTIS Part Ii Submission Date
11-03-2024
Latest Decision Or Authorization Date
18-03-2024
Processing Time Days
7
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Albert Schweitzer Ziekenhuis
Department Name
Afdeling Interne geneeskunde, Trials & Research
Contact Person Name
Jeroen Van der Net
Contact Person Email
j.b.vandernet@asz.nl
Site Name
Amphia Hospital
Department Name
Afdeling Oncologie / Interne Geneeskunde
Contact Person Name
Rene Bakker
Contact Person Email
renebakker@amphia.nl
Site Name
Meander Medisch Centrum Stichting
Department Name
interne geneeskunde
Contact Person Name
Peter Luik
Contact Person Email
pt.luik@meandermc.nl

Spain

Earliest CTIS Part Ii Submission Date
16-02-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
817
Number Of Sites
7
Number Of Participants
35

Sites

Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Nefrologia
Contact Person Name
Mercedes Salgueira Lazo
Site Name
Hospital Polusa S.A.
Department Name
Nefrologia
Contact Person Name
Secundino Jose Cigarran Guidris
Site Name
Bellvitge University Hospital
Department Name
Nefrologia
Contact Person Name
Miguel Hueso Val
Contact Person Email
mhueso@bellvitgehospital.cat
Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Nefrologia
Contact Person Name
Claudia Marcela Castillo Devia
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Nefrologia
Contact Person Name
Jose Luis Gorriz Teruel
Contact Person Email
jlgorriz@gmail.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Nefrologia
Contact Person Name
Maria Marques Vidas
Contact Person Email
mmvidas@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Nefrologia
Contact Person Name
Enrique Morales Ruiz
Contact Person Email
emoralesr@senefro.org

Sweden

Earliest CTIS Part Ii Submission Date
20-02-2024
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
811
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Dalecarlia Clinical Research Center
Department Name
Dalecarlia Clinical Research Center
Contact Person Name
Hans Larnefeldt
Contact Person Email
hans@dalecarliaresearch.se
Site Name
Linkoping University Hospital Region Ostergotland
Department Name
Linköping University Hospital Renal Medicine Garnisonsvägen 10 581 85 Linköping
Contact Person Name
Annette Bruchfeld
Contact Person Email
region@regionostergotland.se
Site Name
Karolinska University Hospital
Department Name
Karolinska Universitetssjukhuset Huddinge ME Njurmedicin, M89 S-141 86 Stockholm
Contact Person Name
Olof Heimbürger
Site Name
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Department Name
Sahlgrenska University Hospital Njurmottagningen Vita Stråket 12, S-413 46
Contact Person Name
Gregor Guron
Contact Person Email
gregor.guron@vgregion.se
Site Name
Uppsala University Hospital
Department Name
Akademiska Sjukhuset Njursektionen Specialmedicin 751 85 Uppsala
Contact Person Name
Hans Furuland
Contact Person Email
hans.furuland@medsci.uu.se

Germany

Earliest CTIS Part Ii Submission Date
23-02-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
810
Number Of Sites
7
Number Of Participants
30

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
"Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin"
Contact Person Name
Adrian Schreiber
Contact Person Email
adrian.schreiber@charite.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Medizinische Klinik I
Contact Person Name
Julia Weinmann-Menke
Site Name
"Zentrum für Nieren - Hochdruck und Stoffwechselerkrankungen"
Contact Person Name
Georg Schlieper
Site Name
Studienzentrum Dr. Faulmann GbR
Contact Person Name
Frank Schaper
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
"Medizinische Klinik und Poliklinik IV Nephrologisches Zentrum"
Contact Person Name
Volker Vielhauer
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Medizinische Klinik II
Contact Person Name
Marcus Möller
Contact Person Email
mmoeller@ukaachen.de
Site Name
Medizinische Hochschule Hannover
Department Name
Studienzentrum für Nieren- und Hochdruckerkrankungen
Contact Person Name
Kai Schmidt-Ott
Contact Person Email
Schmidt-Ott.kai@mh-hannover.de

Austria

Earliest CTIS Part Ii Submission Date
23-02-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
810
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Department Name
Internal Medicine III Nephrology, Dialysis and Hypertension
Contact Person Name
Emanuel Zitt
Contact Person Email
emanuel.zitt@lkhf.at
Site Name
Klinik Hietzing
Department Name
Medical department 3
Contact Person Name
Thomas Stulnig

Norway

Earliest CTIS Part Ii Submission Date
22-02-2024
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
809
Number Of Sites
5
Number Of Participants
28

Sites

Site Name
Nordlandssykehuset HF
Department Name
Department of Nephrology
Contact Person Name
Hans Arne Myhre
Contact Person Email
hans.arne.myhre@nlsh.no
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Department of Nephrology
Contact Person Name
Marit Solbu
Contact Person Email
Marit.Solbu@unn.no
Site Name
Akershus University Hospital
Department Name
Department for internal medicine and lab subjects
Contact Person Name
Bartlomiej Jozef Witczak
Contact Person Email
bartlomiej.j.witczak@ahus.no
Site Name
Oslo University Hospital HF
Department Name
Department of Nephrology
Contact Person Name
Bård Waldum-Grevbo
Contact Person Email
uxwabr@ous-hf.no
Site Name
Helse Stavanger HF
Department Name
Department of Clinical Medicine
Contact Person Name
Lasse Gunnar Gøransson
Contact Person Email
lasse.gunnar.goransson@sus.no

Poland

Earliest CTIS Part Ii Submission Date
20-02-2024
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
815
Number Of Sites
11
Number Of Participants
35

Sites

Site Name
American Heart Of Poland S.A.
Department Name
Oddział Intensywnej Opieki Kardiologicznej
Contact Person Name
Aleksander Zurakowski
Contact Person Email
olekzurakowski@gmail.com
Site Name
Futuremeds Sp. z o.o. (Cracow)
Department Name
Krakowskie Centrum Medyczne
Contact Person Name
Ewelina Malec
Contact Person Email
ewelina.malec@futuremeds.com
Site Name
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Department Name
Centrum Wsparcia Badan Klinicznych Uniwersytetu Medycznego w Lublinie
Contact Person Name
Krzysztof Giannopoulos
Contact Person Email
krzysztofgiannopoulos@umlub.pl
Site Name
Prywatny Gabinet Lekarski Centrum Medyczne DIABETIKA Dorota Mlodawska-Choluj
Department Name
Prywatny Gabinet Lekarski Centrum Medyczne DIABETIKA Dorota Mlodawska-Choluj
Contact Person Name
Dorota Mlodawska-Choluj
Contact Person Email
info@diabetika.radom.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
Department Name
Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych
Contact Person Name
Kazimierz Ciechanowski
Site Name
Futuremeds Sp. z o.o. (Warsaw)
Department Name
Futuremeds Targowek
Contact Person Name
Agnieszka Jurek-Urbanowska
Site Name
„LANDA” Katarzyna Agata Landa
Department Name
Nephrology office
Contact Person Name
Katarzyna Landa
Contact Person Email
landa@smo.com.pl
Site Name
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o.
Department Name
Poradnia Internistyczna
Contact Person Name
Krzysztof Pawlaczyk
Contact Person Email
kpawlac@ump.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie (alternate)
Department Name
Oddział Wieloprofilowy Zachowawczy
Contact Person Name
Krzysztof Giannopoulos
Contact Person Email
krzysztofgiannopoulos@umlub.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Department Name
Klinika Nefrologii, Hipertensjologii, Transplantologii i Chorob Wewnetrznych
Contact Person Name
Michal Nowicki
Contact Person Email
nefro@wp.pl
Site Name
Centrum Medyczne Medyk Sp. z o.o. S.K.
Department Name
Centrum Medyczne Medyk
Contact Person Name
Robert Brodziak
Contact Person Email
rbrodziak@poczta.onet.pl

France

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
796
Number Of Sites
9
Number Of Participants
30

Sites

Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Service de Néphrologie-Hypertension artérielle-Dialyse-Transplantation rénale
Contact Person Name
Jean-Michel Halimi
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Service de Néphrologie
Contact Person Name
Christophe Mariat
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service de Néphrologie, Dialyse et transplantation
Contact Person Name
Sophie Caillard Ohlmann
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service de Néphrologie
Contact Person Name
Guillaume Favre
Contact Person Email
favre.g@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Service de Néphrologie-Dialyses-Aphérèse
Contact Person Name
Olivier Moranne
Contact Person Email
olivier.moranne@chu-nimes.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Service de Néphrologie
Contact Person Name
Pierre-Louis Carron
Contact Person Email
plcarron@chu-grenoble.fr
Site Name
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Department Name
Service de Néphrologie
Contact Person Name
François Chantrel
Contact Person Email
CHANTRELF@ghrmsa.fr
Site Name
CHU De Rouen
Department Name
Service de Néphrologie
Contact Person Name
Dominique Guerrot
Contact Person Email
dominique.guerrot@chu-rouen.fr
Site Name
Centre Hospitalier Universitaire De Tours (additional)
Department Name
Service de Néphrologie
Contact Person Name
Jean-Michel Halimi

Bulgaria

Earliest CTIS Part Ii Submission Date
21-02-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
812
Number Of Sites
9
Number Of Participants
35

Sites

Site Name
Medical Center Exacta Medica OOD
Department Name
Nephrology office
Contact Person Name
Tsvetelina Staykova
Contact Person Email
dr_eftimova@doctorstudy.eu
Site Name
MBAL Med Line Clinic AD
Department Name
Department of Endocrinology and Metabolic diseases
Contact Person Name
Dimitar Georgiev
Contact Person Email
ddime@mail.bg
Site Name
Kalimat Medical Center Ltd.
Department Name
Nephrology office
Contact Person Name
Ventsislav Shurliev
Contact Person Email
ventsidoc55@yahoo.com
Site Name
Medical Center Viva Phoenix OOD
Department Name
Nephrology office
Contact Person Name
Albena Vasileva
Contact Person Email
dr_albena_vasileva@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Department Name
Clinic of Endocrinology and Metabolic diseases
Contact Person Name
Boyan Nonchev
Contact Person Email
nonchev_md@abv.bg
Site Name
Medicinski Centar Hipokrat-N EOOD
Department Name
Nephrology office
Contact Person Name
Dimitar Nikolov
Contact Person Email
dr.georgi.nikolov@gmail.com
Site Name
Umbal - Prof. D-R Stoyan Kirkovich AD
Department Name
Clinic of Internal diseases
Contact Person Name
Iliya Popov
Contact Person Email
dr.iliya.dpopov@gmail.com
Site Name
Medical Center Exacta Medica OOD (additional)
Department Name
Nephrology office
Contact Person Name
Tsvetelina Staykova
Contact Person Email
dr_eftimova@doctorstudy.eu
Site Name
MBAL Med Line Clinic AD (additional)
Department Name
Department of Endocrinology and Metabolic diseases
Contact Person Name
Dimitar Georgiev
Contact Person Email
ddime@mail.bg

Denmark

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
789
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Aarhus Universitetshospital
Department Name
Department of Renal Medicine
Contact Person Name
Niels Henrik Buus
Contact Person Email
NIBUUS@rm.dk
Site Name
Region Sjaelland
Department Name
Department of Medicine
Contact Person Name
Rikke Borg
Contact Person Email
rbor@regionsjaelland.dk
Site Name
Steno Diabetes Center
Department Name
Department of Diabetes
Contact Person Name
Peter Rossing
Contact Person Email
peter.rossing@regionh.dk
Site Name
Aalborg University Hospital
Department Name
Department of Renal Medicine
Contact Person Name
Thomas Lauridsen
Contact Person Email
T.Lauridsen@rn.dk
Site Name
Region Midtjylland
Department Name
Department of Medicine
Contact Person Name
Jesper Nørgaard Bech

Italy

Earliest CTIS Part Ii Submission Date
20-02-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
813
Number Of Sites
8
Number Of Participants
30

Sites

Site Name
Azienda Ospedaliera Papa Giovanni XXIII
Department Name
SC Malattie Endocrine-Diabetologia
Contact Person Name
Roberto Trevisan
Contact Person Email
rtrevisan@asst-pg23.it
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
Medical and Surgical Sciences
Contact Person Name
Giovanni Stallone
Contact Person Email
Giovanni.stallone@unifg.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UOC Nephrology Transplantation and Dialysis
Contact Person Name
Vincenzo Panichi
Contact Person Email
vincenzo.panichi@unipi.it
Site Name
Azienda Ospedaliero Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Unit of Nephrology and Dialysis and Postgraduate School of Nephrology
Contact Person Name
Luca De Nicola
Contact Person Email
luca.denicola@unicampania.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Department Name
Struttura Complessa di Nefrologia, Dialisi e Trapianto
Contact Person Name
Gaetano La Manna
Contact Person Email
gaetano.lamanna@unibo.it
Site Name
Azienda Ospedaliero-Universitaria Citta' Della Salute E Della Scienza Di Torino
Department Name
SC Nefrologia, dialisi e trapianto
Contact Person Name
Luigi Biancone
Contact Person Email
luigi.biancone@unito.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Medicine Integrated with the Territory
Contact Person Name
Francesca Viazzi
Contact Person Email
Francesca.viazzi@unige.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Experimental Medicine
Contact Person Name
Raffaella Buzzetti
Contact Person Email
raffaella.buzzetti@uniroma1.it

Slovakia

Earliest CTIS Part Ii Submission Date
23-02-2024
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
810
Number Of Sites
7
Number Of Participants
35

Sites

Site Name
Lc Ren s.r.o.
Department Name
Outpatient Clinic for Nephrology
Contact Person Name
Radovan Haffner
Contact Person Email
lcren@slovanet.sk
Site Name
Diabetol s.r.o.
Department Name
Outpatient Clinic for Diabetology, Metabolism and Nutrition Disorders
Contact Person Name
Tatiana Lisa
Contact Person Email
tanlis104@gmail.com
Site Name
Areteus s.r.o.
Department Name
Outpatient Clinic for Diabetology, Metabolism and Nutrition Disorders
Contact Person Name
Daša Skirpová
Contact Person Email
Areteus.diabetologia@gmail.com
Site Name
BIODIAL spol. s.r.o.
Department Name
Nephrology and Dialysis Unit
Contact Person Name
Iveta Smatanová
Contact Person Email
ambulancia@biodial.sk
Site Name
IN DIA s.r.o.
Department Name
Outpatient Clinic for Internal Medicine and Diabetology, Metabolism and Nutrition Disorders
Contact Person Name
Lívia Tomášová
Contact Person Email
liviatomasova66@gmail.com
Site Name
Tatratrial s.r.o.
Department Name
Outpatient Clinic for Diabetology, Metabolism and Nutrition Disorders
Contact Person Name
Dalibor Šošovec
Contact Person Email
info@tatratrial.sk
Site Name
Areteus s.r.o. (additional)
Department Name
Outpatient Clinic for Diabetology, Metabolism and Nutrition Disorders
Contact Person Name
Daša Skirpová
Contact Person Email
Areteus.diabetologia@gmail.com

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
Zibotentan + Dapagliflozin
Active Substance
Dapagliflozin; Zibotentan
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus:1
Investigational Product Name
DAPAGLIFLOZIN
Active Substance
Dapagliflozin
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus:2
Combination Treatment
Yes

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