A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN)

• Conditions: MN is an autoimmune disease, suggesting that the disease may be triggered by isotype specific autoantibodies directed against podocyte enzymes and podocyte receptors that are recognized as antigens. The key role of IgG antibodies formation in the pathogenesis of IMN suggests that B cell depletion may favourably impact the evolution of the glomerular disease and reduce proteinuria. We propose this study in order to test in a randomized controlled trial the hyp; MedDRA version: 14.1Level: PTClassification code 10018372Term: Glomerulonephritis membranousSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2011-006115-59-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-08
• Last Update Posted: 31 July 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Biopsy diagnosis of idiopathic MN, performed in the last 24 months
2. Proteinuria> 3.5 g/24h in three measurements (one measurement for 3 weeks)
3. Estimated GFR (MDRD formula) = 50ml/min/1.73m2 treated with ACE inhibitors / ARBs
4. Physiological or surgically menopausal women, women who implement an approved method of contraception
5. Failure in treatment with ACE inhibitors or ARBs to be first 3 months of treatment with RTX
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Serum creatinine> 2.0mg/dl; eGFR <50 ml/min/1.73m2,
2. Previous treatment with rituximab, steroids, alkylating agents, calcineurin inhibitor, ACTH, MMF, azathioprine
3. Presence of active infection
4. Secondary causes of MN (eg hepatitis B, SLE, drugs, tumors). Testing for HIV, hepatitis B and C run less than 6 months before study
5. Diabetes mellitus type 1 and 2
6. Pregnancy or breast-feeding for safety

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified