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