Clinical Trial: Treatment of Patients With Idiopathic Membranous Nephropathy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Treatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive Therapy
Brief Summary: Patients with idiopathic membranous nephropathy at risk for renal failure can be identified in an early stage by measuring urinary low molecular weight proteins and urinary immunoglobulin G (IgG). This study evaluates the possible benefit of early start of immunosuppressive therapy in these high-risk patients.
Detailed Summary:
Inclusion Criteria:
- patients with idiopathic membranous nephropathy
- nephrotic syndrome
- normal renal function (serum creatinine [Screat] < 1.5 mg/dl)
- elevated urinary beta2-microglobulin and IgG
Immunosuppressive therapy consisting of:
- cyclophosphamide 1.5 mg/kg/day for 12 months
- prednisone orally, 0.5 mg/kg on alternate days for 6 months
- i.v. methylprednisolone 1000 mg on days 1,2,3, 60,61,62, 120,121,122
Study Groups:
- early: immediate start of immunosuppressive therapy at the time patient is identified as high-risk
- late: start of therapy after deterioration of renal function (increase of Screat > 25% and Screat > 1.5 mg/dl)
Main Outcome Parameters:
- serum creatinine
- remission of proteinuria
- period of nephrotic proteinuria
- major side effects: hospitalisations, infections
Sponsor: Radboud University
Current Primary Outcome:
- renal function (serum creatinine)
- proteinuria
- side effects
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Radboud University
Dates:
Date Received: August 25, 2005
Date Started: July 1997
Date Completion:
Last Updated: January 27, 2014
Last Verified: February 2007