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OpenTrials
Completed

NCT Number: NCT00135954

Treatment of Patients With Idiopathic Membranous Nephropathy

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.

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Key information

Conditions

Glomerulonephritis, Membranous Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Nephrology Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Idiopathic membranous nephropathy
  • Serum creatinine < 1.5 mg/dl
  • Nephrotic syndrome

Exclusion criteria

  • Infection
  • Instable angina
  • Systemic disease
  • Pregnancy
  • Renal vein thrombosis
  • Prior therapy with immunosuppressant agents
  • Liver dysfunction
  • Use of nonsteroidal anti-inflammatory drugs (NSAIDs)

Treatment and study plan

Cyclophosphamide and steroids

Drug

comparison of difference in time of start of therapy

Other names: prednisolone, endoxan

Primary outcomes

  1. renal function (serum creatinine)

  2. proteinuria

  3. side effects

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Treatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive Therapy

Important dates

Study start
1997
Primary completion
2008
Study completion
2008
First posted
Aug 26, 2005
Registry last updated
Jan 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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