Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
334
Countries
1
Sites
16
IgA nephropathy
To demonstrate, at 3 years, the efficacy of Hydroxychloroquine versus placebo to improve GFR decrease in biopsy-proven IgA nephropathy patients in patients with albuminuria > 300mg/g despite an optimized nephroprotective treatment with RAAS inhibitors, and with at least one Oxford lesion
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Saint Etienne
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 26 Jun 2025 → ongoing
- Decision date (initial)
- 2024-09-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- French Ministry of Health
External identifiers
- EU CT number
- 2024-512653-25-00
- ClinicalTrials.gov
- NCT06350630
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
To demonstrate, at 3 years, the efficacy of Hydroxychloroquine versus placebo to improve GFR decrease in biopsy-proven IgA nephropathy patients in patients with albuminuria > 300mg/g despite an optimized nephroprotective treatment with RAAS inhibitors, and with at least one Oxford lesion
Secondary objectives 6
- To evaluate the effects of hydroxychloroquine on routine nephrologic evaluation each year (proteinuria, albuminuria, GFR, hematuria)
- To evaluate the effects of hydroxychloroquine on progression to end stage renal disease (ESRD) and deaths
- To evaluate the safety of hydroxychloroquine
- To evaluate the impact of hydroxychloroquine blood concentrations on therapeutic effects
- To evaluate the impact of hydroxychloroquine blood concentrations on adverse events
- To constitute a biocollection to explore further research hypothesis (immune system monitoring, cystatin C…)
Conditions and MedDRA coding
IgA nephropathy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10021263 | IgA nephropathy | 100000004857 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment Comparing Hydroxychloroquine to placebo in patients with biopsy proven IgA nephropathy, urine albumin/creatinine > 300mg/g despite optimized RAAS blocking treatment, with at least one Oxford lesion (M, E, S, T, C) on diagnostic kidney biopsy and GFR above 15 mL/min/1.73m² (CKD-EPI formula)
|
Randomised Controlled | Double | [{"id":137919,"code":2,"name":"Investigator"},{"id":137921,"code":1,"name":"Subject"},{"id":137920,"code":4,"name":"Analyst"}] | Groupe 1: Active HCQ once daily by oral route at 6.5mg/kg of ideal weight/day, mith maximal dose of 400mg/day Groupe 2: Placebo tablet of HCQ at the same dosage |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- Social security affiliation
- Signed informed consent
- Patients over 18 years-old
- With biopsy proven IgA nephropathy (any vintage)
- With urine albumin/creatinine > 300mg/g
- Under maximal tolerated labeled dose of RAAS inhibitors for at least 3 months
- With at least one Oxford lesion (M, E, S, T, C) on last available kidney biopsy
- With eGFR above 15 mL/min/1,73m² (CKD-EPI formula)
- With at least one highly effective contraceptive method for women of childbearing age
- Only patients treated with dual SGLT2i and RAAS therapy before inclusion
Exclusion criteria 8
- Secondary IgA nephropathy (Henoch Schonlein purpura, cirrhosis, inflammatory bowel disease)
- Corticosteroid (systemic and/or targeted-release formulation) or immunosuppressive therapies in the past year before screening
- Contra-indication to hydroxychloroquine (retinopathy, maculopathy, history of intolerance to HCQ…)
- Uncontrolled hypertension (SBP> 160 and/or DBP>110)
- Long QT interval and/or QT prolonging medicines
- Pregnancy or lactation
- - QT prolonging medicines : citalopram, escitalopram, hydroxyzine, dompéridone and pipéraquine
- Sparsentan initiated less than 1 month before inclusion visit
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- GFR slope form inclusion to 3 years
Secondary endpoints 6
- Difference between groups regarding routine nephrological clinical follow-up (proteinuria, albuminuria, GFR, hematuria, systolic and diastolic blood pressure) at 1, 2 and 3 years
- Difference in proportion of end stage renal disease (GFR< 15mL/min/1.73m²) and deaths
- Proportion of adverse events (pruritus, gastro-intestinal disorders) and serious adverse events (QT enlargement, cardiomyopathy, ophthalmologic disorders, neuromyopathy, cytopenia)
- Correlations between hydroxychloroquine trough levels (mean trough level and maximum trough level) and evolution of proteinuria, eGFR, blood pressure
- Correlations between hydroxychloroquine trough levels (mean trough level and maximum trough level) and adverse events (QT interval measurement, any adverse event, serious adverse events)
- Biocollection of plasma, serum, urine and DNA samples
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PLAQUENIL 200 mg comprimés pelliculés sulfate d’hydroxychloroquine
PRD434823 · Product
- Active substance
- Hydroxychloroquine Sulfate
- Substance synonyms
- 2-[4-[(7-CHLOROQUINOLIN-4-YL)AMINO]PENTYL-ETHYL-AMINO]ETHANOL, SULFURIC ACID, HYDROXYCHLOROQUINE SULPHATE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- P01BA02 — HYDROXYCHLOROQUINE
- Marketing authorisation
- 0091344
- MA holder
- SANOFI BELGIUM
- MA country
- Luxembourg
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- population (IgA nephropathy) off marketing authorization
Placebo 1
placebo plaquenil pharmaceutical form: tablets active substance: not applicable
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Saint Etienne
- Sponsor organisation
- Centre Hospitalier Universitaire De Saint Etienne
- Address
- Avenue Albert Raimond
- City
- Saint Priest En Jarez
- Postcode
- 42270
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Saint Etienne
- Contact name
- Project manager
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Saint Etienne
- Contact name
- Project manager
Locations
1 EU/EEA country · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 334 | 16 |
| Rest of world | — | 0 | — |
Investigational sites
Les Hopitaux Universitaires De Strasbourg
Néphrologie, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Assistance Publique Hopitaux De Paris
Néphrologie, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire Grenoble Alpes
Néphrologie, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Assistance Publique Hopitaux De Paris
Néphrologie, 20 Rue Leblanc, 75015, Paris
Centre Hospitalier Regional De Marseille
Département de Néphrologie et Transplantation rénale, 147 Boulevard Baille, 13005, Marseille
Hospices Civils De Lyon
Département de Néphrologie, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Hopital Tenon
Département de Néphrologie, 4 Rue De La Chine, 75970, Paris Cedex 20
Hospital Edouard Herriot
Département de Néphrologie, 5 Place D Arsonval, 69437, Lyon Cedex 03
Centre Hospitalier Universitaire De Rennes
Néphrologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Saint Etienne
Département de Néphrologie, Dialyse et Transplantation rénale, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Centre Hospitalier Et Universitaire De Limoges
Service de néphrologie, 2 Avenue Martin Luther King, 87000, Limoges
Assistance Publique Hopitaux De Paris
Département de Néphrologie, 46 Rue Henri Huchard, 75877, Paris Cedex 18
CHU Gabriel-Montpied
Département de Néphrologie, Dialyse et Transplantation rénale, 58 Rue Montalembert, 63000, Clermont Ferrand
Centre Hospitalier De Valenciennes
Néphrologie, 114 Avenue Desandrouin, 59300, Valenciennes
Centre Hospitalier Universitaire De Nimes
Néphrologie, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Centre Hospitalier Universitaire De Nantes
Néphrologie, 30 Boulevard Jean Monnet, 44000, Nantes
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-06-26 | 2025-06-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PROTOCOL_2024-512653-25-00 | 2 |
| Protocol (for publication) | D1_PROTOCOL_2024-512653-25-00_TC | 4 |
| Protocol (for publication) | D1_PROTOCOLE_2024-512653-25-00 | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_TC | 2.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Plaquenil | 1 |
| Synopsis of the protocol (for publication) | D1_SYNOPSIS_2024-512653-25-00 | 4 |
| Synopsis of the protocol (for publication) | D1_SYNOPSIS_2024-512653-25-00 | 2 |
| Synopsis of the protocol (for publication) | D1_SYNOPSIS_2024-512653-25-00_TC | 4 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-24 | France | Acceptable 2024-09-09
|
2024-09-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-26 | France | Acceptable 2024-12-30
|
2024-12-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-07 | France | Acceptable 2025-02-26
|
2025-02-27 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-05 | France | Acceptable 2025-02-26
|
2025-03-05 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-13 | France | Acceptable | 2025-05-28 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-29 | France | Acceptable | 2025-08-08 |