Mycophenolate Mofetil in Membranous Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00135967
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : December 6, 2005
Hoffmann-La Roche
Information provided by:
Radboud University

August 25, 2005
August 26, 2005
December 6, 2005
May 2002
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  • renal function (serum creatinine)
  • proteinuria
  • - renal function (serum creatinine)
  • - proteinuria
Complete list of historical versions of study NCT00135967 on Archive Site
  • side effects
  • relapse rate
  • - side effects
  • - relapse rate
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Mycophenolate Mofetil in Membranous Nephropathy
Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study

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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Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Glomerulonephritis, Membranous
  • Drug: 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
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Branten AJ, du Buf-Vereijken PW, Vervloet M, Wetzels JF. Mycophenolate mofetil in idiopathic membranous nephropathy: a clinical trial with comparison to a historic control group treated with cyclophosphamide. Am J Kidney Dis. 2007 Aug;50(2):248-56.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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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)
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Radboud University
Hoffmann-La Roche
Principal Investigator: Jack F Wetzels, MD Radboud University
Radboud University
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP