Status:
COMPLETED
Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Idiopathic Membranous Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The Membranous Nephropathy is one of the most common cause of Nephrotic Syndrome of adults. In 2/3 of patients the cause of the disease is idiopathic. This can also be referred to as idiopathic membra...
Detailed Description
The IMN exposes patients to severe complications which engage the vital prognosis or Nephrotic Syndrome. The development of well tolerated and effective pathogenesis linked therapies is needed to tre...
Eligibility Criteria
Inclusion
- At least 18 years old.
- Idiopathic Membranous nephropathy proved by renal biopsy
- Persistent urinary protein excretion rate ≥3,5g/24 h and albuminemia \< 30g/l for at least 6 months with full dose of NIST
- Patient receiving a non immunosuppressive conventional treatment (antiproteinuric and antihypertensive blocking the rennin-angiotensine system, lipid-lowering statin) since at least 6 months.
- Patient has given its written consent
- Patient with social coverage (excepting AME)
- Use of an efficient contraception method for women in childbearing age.
Exclusion
- Secondary membranous nephropathy
- Patient already in a clinical trial
- Patient received an immunosuppressive treatment within 3 months before the study
- Patient with chronic renal disease defined by estimated GFR by MDRD formula under 30ml/mn/1,73m²
- Pregnancy and breastfeeding
- HIV infection, HCV and HBV active infection
- Severe or evolving infections.
- Allergy or hypersensitivity to Rituximab or any component
Key Trial Info
Start Date :
January 17 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01508468
Start Date
January 17 2012
End Date
August 31 2016
Last Update
October 26 2021
Active Locations (1)
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1
Department of Nephrology , Tenon hospital - APHP
Paris, France