Mycophenolate Mofetil in Membranous Nephropathy

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00135967
First received: August 25, 2005
Last updated: December 5, 2005
Last verified: August 2005

August 25, 2005
December 5, 2005
May 2002
Not Provided
  • renal function (serum creatinine)
  • proteinuria
  • - renal function (serum creatinine)
  • - proteinuria
Complete list of historical versions of study NCT00135967 on ClinicalTrials.gov Archive Site
  • side effects
  • relapse rate
  • - side effects
  • - relapse rate
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Not Provided
 
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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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)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00135967
RUNMN02
Not Provided
Not Provided
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