Overview

Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy

Status:
Completed
Trial end date:
2016-08-31
Target enrollment:
0
Participant gender:
All
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 membranous nephropathy (IMN).The most of these patients are treated by non immunosuppressive symptomatic treatment (NIST): antiproteinuric and antihypertensive blocking the rennin-angiotensine system. However, the patients resistant to antiproteinuric treatment risk to develop an end stage renal disease (ESRD). Rituximab has been recently used in patients suffering of nephrotic syndrome related to IMN in four international studies. Rituximab appears effective and safe in reducing proteinuria in nearly 60% of patients. The primary outcome of the investigators prospective randomized study is to determine whether or not the Rituximab associated with NIST is more effective than non immunologic symptomatic treatment alone in inducing long term remission of proteinuria.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
Adrenergic beta-Antagonists
Angiotensin II
Angiotensin Receptor Antagonists
Angiotensinogen
Calcium
Calcium, Dietary
Diuretics
Enzyme Inhibitors
Giapreza
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Mineralocorticoid Receptor Antagonists
Rituximab
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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