Clinical trial • Phase III • Immunology|Nephrology

Prednisone for Idiopathic IgA nephropathy

Phase III trial of Prednisone for Idiopathic IgA nephropathy.

Overview

Trial Therapeutic Area
Immunology|Nephrology
Trial Disease
Idiopathic IgA nephropathy
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
13-09-2024
First CTIS Authorization Date
16-10-2024

Trial design

Randomised, open-label, control arms described as: acigan control: rasbs treatment followed by corticosteroids combined with rasbs and then only rasbs (no doses/schedules specified). chronigan control: rasbs therapy followed by corticosteroids combined with rasbs and then rasbs alone. experimental/comparator arms include dapagliflozin combined with rasbs (dose not specified in arm descriptions). Phase III trial in Italy.

Randomised
Yes
Open Label
Yes
Comparator
Control arms described as: ACIgAN control: RASBs treatment followed by corticosteroids combined with RASBs and then only RASBs (no doses/schedules specified). CHRONIgAN control: RASBs therapy followed by Corticosteroids combined with RASBs and then RASBs alone. Experimental/comparator arms include Dapagliflozin combined with RASBs (dose not specified in arm descriptions).
Biomarker Stratified
True: stratified by kidney biopsy findings (active renal lesions: E1 and/or C1 versus chronic lesions: T1,2 or moderate lesions M0,1 S0,1 E0 T0 C0)
Target Sample Size
432
Trial Duration For Participant
1095

Eligibility

Recruits 432 isVulnerablePopulationSelected = true. Participants are adults (aged 18–75) and must provide written informed consent. Subject information and informed consent form document is available ('CLIgAN Foglio informativo e modulo consenso informato v 4 del 14 09 2022 clean'). No procedures for assent or parental consent for minors are mentioned (the inclusion criteria specify adults only)..

Pregnancy Exclusion
18. Pregnancy and breastfeeding.
Vulnerable Population
isVulnerablePopulationSelected = true. Participants are adults (aged 18–75) and must provide written informed consent. Subject information and informed consent form document is available ('CLIgAN Foglio informativo e modulo consenso informato v 4 del 14 09 2022 clean'). No procedures for assent or parental consent for minors are mentioned (the inclusion criteria specify adults only).

Inclusion criteria

  • {"criterion_text":"- ACIgAN study 1. Males and females aged 18 to 75 years."}
  • {"criterion_text":"- 2. Written informed consent form."}
  • {"criterion_text":"- 3. Biopsy-proven idiopathic IgAN with active (E1 and/or C1) within 2 weeks."}
  • {"criterion_text":"- 4. eGFR >= 30 ml/min/1.73 m2."}
  • {"criterion_text":"- 5. 24 hour proteinuria >= 0.5 g."}
  • {"criterion_text":"- 6. Patients on treatment or candidate for the treatment with RASBs (either an ACEi or ARB), as per clinical practice, according to the current KDIGO guidelines."}
  • {"criterion_text":"- CHRONIgAN study 1. Males and females aged 18 to 75 years."}
  • {"criterion_text":"- 2. Written informed consent form."}
  • {"criterion_text":"- 3. Biopsy-proven idiopathic IgAN with chronic (T1,2) or moderate (M0,1, S0,1, E0, T0, C0) renal lesions at high or very high CKD risk within 4 weeks."}
  • {"criterion_text":"- 4. eGFR >= 30 ml/min/1.73 m2."}
  • {"criterion_text":"- 5. 24-hour proteinuria >= 0.5 g."}
  • {"criterion_text":"- 6. Patients on treatment or candidate for the treatment with RASBs (either an ACEi or ARB), as per clinical practice, according to the current KDIGO guidelines."}

Exclusion criteria

  • {"criterion_text":"- 1. Non biopsy-proven IgAN"}
  • {"criterion_text":"- 2. IgAN patients with minimal change disease at kidney biopsy and nephrotic syndrome."}
  • {"criterion_text":"- 3. IgAN patients with macrohematuria and acute renal failure."}
  • {"criterion_text":"- 4. IgAN patients with rapidly progressive glomerulonephritis (extracapillary lesions in more than 25 % of glomeruli in the kidney biopsy)."}
  • {"criterion_text":"- 5. Patients with secondary IgAN (lupus nephritis, Schoenlein-Henoch purpura, liver cirrhosis)."}
  • {"criterion_text":"- 6. Patients with superimposed IgAN in a kidney transplant."}
  • {"criterion_text":"- 7. Patients with other types of glomerular diseases"}
  • {"criterion_text":"- 8. Patients with solitary kidney"}
  • {"criterion_text":"- 9. Patients with end-stage kidney disease"}
  • {"criterion_text":"- 10. Bleeding disorders not responsive to treatment"}
  • {"criterion_text":"- 11. Patients with myocardial infarction or cerebrovascular stroke in the previous six months."}
  • {"criterion_text":"- 12. Severe liver diseases, infections, malignancies."}
  • {"criterion_text":"- 13. Uncontrolled diabetes (glycemia > 200 mg/dL and HbA1c > 7.5%)."}
  • {"criterion_text":"- 14. Aseptic necrosis of any bone."}
  • {"criterion_text":"- 15. Any prior immunosuppressive therapy."}
  • {"criterion_text":"- 16. Other morbidities that can be exacerbated by corticosteroids."}
  • {"criterion_text":"- 17. Previous adverse side effects and/or contraindications to RASBs and SGLT2is."}
  • {"criterion_text":"- 18. Pregnancy and breastfeeding."}
  • {"criterion_text":"- 19. If women of childbearing potential (WOCBP): patients not available to use highly effective contraceptive measures during the study treatment period and up to one month after the last dose of study drugs."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Between-arms difference in proteinuria reduction within 4 months and in nonresponders within 8 months in ACIgAN study.","definition_or_measurement_approach":"Between-arms difference in proteinuria reduction within specified timeframes (ACIgAN: reduction within 4 months and in nonresponders within 8 months)."}
  • {"endpoint_text":"- Between-arms difference in proteinuria reduction within 10 months in CHRONIgAN study.","definition_or_measurement_approach":"Between-arms difference in proteinuria reduction within 10 months in CHRONIgAN."}

Secondary endpoints

  • {"endpoint_text":"- eGFR slope calculated as mean of individual slope obtained from individual linear regression of eGFR overtime (3 years);","definition_or_measurement_approach":"eGFR slope: mean of individual slopes obtained from individual linear regression of eGFR over 3 years."}
  • {"endpoint_text":"- eGFR decline > 40 % from the baseline value;","definition_or_measurement_approach":"Proportion of participants with >40% decline in eGFR from baseline."}
  • {"endpoint_text":"- composite end point: GFR decline > 40%, ESKD (defined as long-term GFR <= 15 ml/min/1.73m2 for more than three months or need for maintenance dialysis or kidney transplantation) or death due to kidney disease;","definition_or_measurement_approach":"Composite endpoint comprising >40% GFR decline, ESKD (long-term eGFR <=15 ml/min/1.73m2 for >3 months or need for maintenance dialysis or transplant) or death due to kidney disease."}
  • {"endpoint_text":"- absolute difference between last GFR value and baseline GFR;","definition_or_measurement_approach":"Difference between last measured eGFR and baseline eGFR."}
  • {"endpoint_text":"- stable renal function defined as a decline in GFR <= 5 ml/min/1.73m2 at the end of three years follow- up","definition_or_measurement_approach":"Stable renal function defined as eGFR decline <=5 ml/min/1.73m2 at 3 years."}
  • {"endpoint_text":"- mean annual change in the slope of the reciprocal of serum creatinine concentration;","definition_or_measurement_approach":"Mean annual change in slope of the reciprocal of serum creatinine concentration."}
  • {"endpoint_text":"- time-averaged proteinuria (TA-P) calculated as the weighted mean of all postrandomisation measurement, with weights representing the time elapsed since the previous measurement;","definition_or_measurement_approach":"TA-P: weighted mean of all post-randomisation proteinuria measurements, weights based on time elapsed since previous measurement."}
  • {"endpoint_text":"- proteinuria slope, calculated as a mean of individual slope, obtained from individual linear regression of daily proteinuria overtime (3 years);","definition_or_measurement_approach":"Proteinuria slope: mean of individual slopes from individual linear regressions of daily proteinuria over 3 years."}
  • {"endpoint_text":"- complete remission of proteinuria defined as achievement of urinary protein level <= 0.2 g/day or a urinary protein-to-creatinine ratio <= 0.2 g/g;","definition_or_measurement_approach":"Complete remission defined as urinary protein <=0.2 g/day or protein-to-creatinine ratio <=0.2 g/g."}
  • {"endpoint_text":"- partial remission of proteinuria defined as achievement of a urinary protein reduction >= 50% or greater compared with the baseline value.","definition_or_measurement_approach":"Partial remission defined as >=50% reduction in urinary protein compared with baseline."}

Recruitment

Planned Sample Size
432
Recruitment Window Months
72
Consent Approach
Written informed consent required from each participant. Subject information and informed consent form available ('CLIgAN Foglio informativo e modulo consenso informato v 4 del 14 09 2022 clean'). Participants are adults (18-75) so consent is provided by the participant. No assent/parental consent procedures for minors are described.

Geography

Total Number Of Sites
52
Total Number Of Participants
432

Italy

Earliest CTIS Part Ii Submission Date
10-09-2024
Latest Decision Or Authorization Date
10-07-2025
Processing Time Days
303
Number Of Sites
52
Number Of Participants
432

Sites

Site Name
Ospedale "SS. Annunziata"
Department Name
Medicina/Nefrologia e Dialisi
Contact Person Name
Mario Bonomini
Contact Person Email
mario.bonomini@unich.it
Site Name
Azienda USL Toscana Sud Est -Ospedale Misericordia - Grosseto
Department Name
Nefrologia
Contact Person Name
Marco Palladino
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
UOSD Nefrologia e Dialisi
Contact Person Name
Carmelita Marcantoni
Contact Person Email
marcantoni.carmelita@gmail.com
Site Name
Ospedale Santa Maria delle Croci
Department Name
Nefrologia
Contact Person Name
Olga Baraldi
Contact Person Email
olga.baraldi3@unibo.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
UOC Clinica Nefrologica, Dialisi e Trapianto
Contact Person Name
Francesca Viazzi
Contact Person Email
francesca.viazzi@unige.it
Site Name
Azienda Ospedaliera Universitaria di Ferrara
Department Name
Nefrologia
Contact Person Name
Rossella Siligato
Contact Person Email
rossella.siligato@ospfe.it
Site Name
Istituti Clinici Scientifici Maugeri S.p.A. Sb
Department Name
Nefrologia e Dialisi
Contact Person Name
Ciro Esposito
Contact Person Email
ciro.esposito@icsmaugeri.it
Site Name
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Department Name
U.O.C. Nefrologia abilitata al Trapianto
Contact Person Name
Francesca Mallamaci
Contact Person Email
francesca.mallamaci@libero.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
S.C. Nefrologia - Clinica Nefrologica
Contact Person Name
Federico Pieruzzi
Contact Person Email
federico.pieruzzi@unimib.it
Site Name
Azienda Ospedaliera-Universitaria Di Cosenza
Department Name
Nefrologia
Contact Person Name
Gianluigi Zaza
Contact Person Email
gianluigi.zaza@unical.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
U.O. di Nefrologia, Dialisi e Trapianto
Contact Person Name
Federico Alberici
Contact Person Email
federico.alberici@unibs.it
Site Name
Azienda Ospedaliera Santa Croce E Carle
Department Name
SC Nefrologia e Dialisi
Contact Person Name
Luca Besso
Contact Person Email
besso.l@ospedale.cuneo.it
Site Name
Casa Sollievo Della Sofferenza
Department Name
Nefrologia e Dialisi
Contact Person Name
Filippo Aucella
Contact Person Email
f.aucella@operapadrepio.it
Site Name
Ospedale Santa Maria della Misericordia (Udine)
Department Name
Nefrologia, Dialisi e Trapianto Renale
Contact Person Name
Giuliano Boscutti
Site Name
Ospedale San Giovanni Bosco
Department Name
SCdU Nefrologia e Dialisi - CMID
Contact Person Name
Dario Roccatello
Contact Person Email
dario.roccatello@unito.it
Site Name
Azienda Ospedaliera di Perugia
Department Name
SC Nefrologia
Contact Person Name
Francesca Timio
Site Name
Azienda Sanitaria Locale Viterbo
Department Name
UOC Nefrologia e Dialisi
Contact Person Name
Sandro Feriozzi
Contact Person Email
sandro.feriozzi@asl.vt.it
Site Name
Ospedale San Giovanni di Dio (Torregalli)
Department Name
Nefrologia
Contact Person Name
Alberto Rosati
Site Name
Ospedale di Prato Santo Stefano
Department Name
Nefrologia
Contact Person Name
Gesualdo Campolo
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti (Foggia)
Department Name
Dipartimento di Scienze Mediche e Chirurgiche/SC Nefrologia, Dialisi e Trapianto
Contact Person Name
Giovanni Stallone
Contact Person Email
giovanni.stallone@unifg.it
Site Name
Ospedale Santa Maria Goretti Latina
Department Name
Nefrologia
Contact Person Name
Dario Musone
Contact Person Email
d.musone@ausl.latina.it
Site Name
Azienda Ospedaliero-Universitaria Di Modena
Department Name
UO Nefrologia Dialisi e Trapianto
Contact Person Name
Riccardo Magistroni
Contact Person Email
riccardo.magistroni@unimore.it
Site Name
IRCCS - Ospedale San Raffaele
Department Name
UO di Nefrologia e Dialisi
Contact Person Name
Giuseppe Vezzoli
Contact Person Email
vezzoli.giuseppe@hsr.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Nefrologia
Contact Person Name
Teresa Rampino
Contact Person Email
T.Rampino@smatteo.pv.it
Site Name
ARNAS Civico Di Cristina Benfratelli
Department Name
UOC di Nefrologia, dialisi e trapianto
Contact Person Name
Angelo Ferrantelli
Contact Person Email
angelo.ferrantelli@gmail.com
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
UO di Nefrologia
Contact Person Name
Enrico Fiaccadori
Contact Person Email
enrico.fiaccadori@unipr.it
Site Name
Central Hospital Of Bolzano
Department Name
UO di Nefrologia
Contact Person Name
Daniela Stringa
Contact Person Email
Daniela.Stringa@sabes.it
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
SC Nefrologia e Dialisi
Contact Person Name
Mariacristina Gregorini
Site Name
Alessandro Manzoni Hospital
Department Name
U.O.C. Nefrologia e Dialisi
Contact Person Name
Vincenzo La Milia
Contact Person Email
v.lamilia@asst-lecco.it
Site Name
Ospedale "Morgagni - Pierantoni" di Forlì
Department Name
Nefrologia
Contact Person Name
Vittorio Albertazzi
Site Name
Universita Degli Studi Di Roma La Sapienza
Department Name
Nefrologia
Contact Person Name
Paolo Menè
Contact Person Email
paolo.mene@uniroma1.it
Site Name
ARNAS G. Brotzu
Department Name
S.C. Nefrologia e Dialisi
Contact Person Name
Antonello Pani
Contact Person Email
antonellopani@aob.it
Site Name
Ospedale Maggiore della Carità Novara
Department Name
Dipartimento di medicina traslazionale/SCDU Nefrologia e Trapianto renale
Contact Person Name
Vincenzo Cantaluppi
Site Name
Ospedale Sandro Pertini
Department Name
Nefrologia
Contact Person Name
Marco Galliani
Contact Person Email
Marco.galliani@aslroma2.it
Site Name
Ospedale Santa Maria Annunziata
Department Name
Nefrologia
Contact Person Name
Chiara Somma
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO di Nefrologia,Trapianti e Dialisi
Contact Person Name
Vincenzo Panichi
Contact Person Email
vincenzo.panichi@unipi.it
Site Name
ASP Ragusa - Ospedale Maggiore Modica
Department Name
Nefrologia
Contact Person Name
Concetto Sessa
Contact Person Email
dirsan.modica@asp.rg.it
Site Name
Presidio Ospedaliero Antonio Perrino
Department Name
Nefrologia
Contact Person Name
Luigi Vernaglione
Contact Person Email
vernalu68@gmail.com
Site Name
IRCCS Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi
Department Name
U.O. di Nefrologia, Dialisi e Trapianto
Contact Person Name
Gaetano La Manna
Contact Person Email
gaetano.lamanna@unibo.it
Site Name
Azienda Ospedaliera Universitaria Mater Domini
Department Name
U.O. Nefrologia - Dialisi
Contact Person Name
Michele Andreucci
Contact Person Email
andreucci@unicz.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
UOC Nefrologia e Dialisi
Contact Person Name
Domenico Santoro
Contact Person Email
dsantoro@unime.it
Site Name
ASL Roma 3 - Presidio Ospedaliero G.B. Grassi
Department Name
UOC Nefrologia e Dialisi
Contact Person Name
Massimo Morosetti
Contact Person Email
massimo.morosetti@aslroma3.it
Site Name
Ospedale Infermi di Rimini
Department Name
UO di Nefrologia e Dialisi
Contact Person Name
Emanuele Mambelli
Site Name
Fondazione IRCCS San Gerardo Dei Tintori (second entry)
Department Name
S.C. Nefrologia - Clinica Nefrologica
Contact Person Name
Andrea Ranghino
Site Name
Azienda Ospedaliera Per L'Emergenza Cannizzaro
Department Name
Nefrologia
Contact Person Name
Antonio Granata
Contact Person Email
antonio.granata4@tin.it
Site Name
Ospedale Vito Fazzi Lecce
Department Name
UO di Nefrologia e Dialisi
Contact Person Name
Antonio De Pascalis
Contact Person Email
depascalis.a@libero.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
UOC Nefrologia, Dialisi e Trapianti di rene
Contact Person Name
Giuseppe Castellano
Site Name
Careggi University Hospital
Department Name
Nefrologia, Dialisi e Trapianto
Contact Person Name
Marco Allinovi
Contact Person Email
marco.allinovi@gmail.com
Site Name
Presidio Ospedaliero Maria SS Addolorata
Department Name
UOC Nefrologia - Dialisi
Contact Person Name
Giuseppe Gigliotti
Contact Person Email
g.gigliotti@aslsalerno.it
Site Name
IRCCS Humanitas Research Hospital
Department Name
Nefrologia
Contact Person Name
Albania Antonietta Calvetta
Contact Person Email
albania.calvetta@humanitas.it
Site Name
Ente Ecclesiastico Ospedale Generale Regionale Miulli
Department Name
U.O.C. Nefrologia e Dialisi
Contact Person Name
Vincenzo Montinaro
Contact Person Email
v.montinaro@miulli.it

Sponsor

Primary sponsor

Full Name
Fondazione Schena Centro Europeo Della Ricerca Sulle Malattie Renali
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Italy

Contract research organisations

Name
Clinical Research Technology S.r.l.
Responsibilities
sponsorDuties codes: 12,5,8; contact email cligan@cr-technology.com

Third parties

  • {"country":"Italy","full_name":"Clinical Research Technology S.r.l.","duties_or_roles":"sponsorDuties codes: 12,5,8; contact: cligan@cr-technology.com","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
PREDNISONE
Active Substance
Prednisone
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
50 mg (maxDailyDoseAmount)
Investigational Product Name
DAPAGLIFLOZIN
Active Substance
Dapagliflozin
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
10 mg (maxDailyDoseAmount)
Investigational Product Name
SOLU MEDROL 1000 mg/15,6 ml polvere e solvente per soluzione iniettabile
Active Substance
Methylprednisolone sodium succinate
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Marketing authorisation: 023202068 (IT)
Maximum Dose
1000 mg (maxDailyDoseAmount)
Combination Treatment
Yes

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