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Completed

NCT Number: NCT00135967

Mycophenolate Mofetil in Membranous Nephropathy

Patients with idiopathic membranous nephropathy and renal insufficiency are at risk for end-stage renal disease (ESRD). Treatment with cyclophosphamide is currently used as a treatment modality. Mycophenolate mofetil is a new immunosuppressive agent with fewer side effects.

In this pilot study patients with membranous nephropathy and renal failure will be treated with mycophenolate mofetil and prednisone. The outcome will be compared with historical controls treated with a similar regimen containing cyclophosphamide.

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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 2 / Phase 3

Primary location

Department of Nephrology Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Membranous nephropathy
  • Serum creatinine (Screat)> 1,5 mg/dl or ECC < 70 ml/min or increase Screat > 50%
  • Proteinuria > 2 g/day

Exclusion criteria

  • Systemic diseases
  • Pregnancy wish
  • Active infection
  • Liver dysfunction
  • Abnormal hematology lab
  • Unstable angina
  • Nonsteroidal anti-inflammatory agents (NSAIDs)

Treatment and study plan

mycophenolate mofetil orally 1000 mg twice a day (BID)

Drug

prednisone 0,5 mg/kg orally on alternate days

Drug

intravenous (i.v.) methylprednisolone 1000 mg, total 9

Drug

Primary outcomes

  1. renal function (serum creatinine)

  2. proteinuria

Secondary outcomes

  1. side effects

  2. relapse rate

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study

Important dates

Study start
2002
First posted
Aug 26, 2005
Registry last updated
Dec 6, 2005

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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