Status:
COMPLETED
Personalized Medicine for Membranous Nephropathy
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Idiopathic Membranous Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Randomized, open label, multicentre (20 sites), prospective trial comparing the efficacy of two therapeutic strategies to obtain clinical remission 1 year after diagnosis of Idiopathic Membranous Neph...
Eligibility Criteria
Inclusion
- Age 18 years or more
- Anti-PLA2R1 activity detected by ELISA or Euroimmune Immunofluorescence Assay
- Nephrotic syndrome defined by proteinuria \> 3.5 g/24h (or UPCR \> 3.5 g/g) and serum albumin \< 30 g/L at diagnosis
- eGFR (CKD-EPI) \> 30 ml/min/1,73 m2 at diagnosis
- Symptomatic treatment according to KDIGO guidelines: maximal tolerated dose of NIAT : Non Immunosuppressive Antiproteinuric Treatment (angiotensin-converting enzyme inhibitor and/or angiotensin 2 receptor blockers, diuretics and statins)
- Medical insurance
- Signed informed consent
- Having understood and accepted the need for long-term medical follow-up
- Woman of child-bearing age must be using an effective method of contraception
Exclusion
- Secondary Membranous Nephropathy: Membranous Nephropathy related to cancer, infectious, systemic lupus erythematosis, drug
- Anti-PLA2R1 antibodies not confirmed by central analysis (in this case the patient will be replaced)
- Pregnancy or breastfeeding
- Immunosuppressive treatment in the 3 last months
- Cancer under treatment
- Patient with complicated nephrotic syndrome that would require early immunosuppressive treatment (thrombosis, acute renal failure…)
- Patients with active, severe infections or active hepatitis B
- Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients
- Patients in a severely immunocompromised state
- Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
- Patients unable to give an informed consent
Key Trial Info
Start Date :
January 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2024
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03804359
Start Date
January 14 2020
End Date
November 5 2024
Last Update
July 25 2025
Active Locations (19)
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1
CHU D'amiens Hôpital Sud
Amiens, France, 80800
2
CHU Besançon
Besançon, France, 25000
3
Hôpital universitaire La Cavale Blanche
Brest, France, 29069
4
CHU de Caen
Caen, France, 14033