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Clinical Trials/EUCTR2011-006115-59-IT
EUCTR2011-006115-59-IT
Active, not recruiting
Not 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 sitesJune 8, 2012
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ConditionsMN 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 hypMedDRA version: 14.1Level: PTClassification code 10018372Term: Glomerulonephritis membranousSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
DrugsMABTHERA*EV 1FL 50ML 500MGURBASON*IM EV 1F 250MG+1F 5MLMEDROL*10CPR DIV 4MGENDOXAN BAXTER*50CPR RIV 50MG

Overview

Phase
Not Applicable
Intervention
Not specified
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
Sponsor
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 8, 2012
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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