EUCTR2011-006115-59-ITActive, not recruitingNot Applicable
A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN) - GNM-2011
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA0 sitesStarted: June 8, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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