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Mycophenolate Mofetil in Membranous Nephropathy - Article


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Clinical Trial: Mycophenolate Mofetil in Membranous Nephropathy

This study has been completed.

Sponsors and Collaborators: Radboud University
Roche The Netherlands
Information provided by: Radboud University
ClinicalTrials.gov Identifier: NCT00135967

Purpose

Patients with idiopathic membranous nephropathy and renal insuffficiency are at risk for ESRD. Treatment with cyclophosphamide is currently used as 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 mycophemolate mofetil and prednisone. Outcome will be compared with historical controls treated with a similar regimen containing cyclophosphamide

Condition Intervention Phase
Glomerulonephritis, Membranous
  Drug: mycophenolate mofetil orally 1000 mg BID
 Drug: prednisone 0,5 mg/kg orally on alternate days
 Drug: i.v. methylprednisolone 1000 mg, total 9
 Phase II
Phase III

MedlinePlus related topics:  Autoimmune Diseases;   Kidney Diseases

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Official Title: Treatment of Patients with Membranous Nephropathy and Renal Insufficiency with Mycophenolate Mofetil and Prednisone: a Pilot Study

Further Study Details: 
Primary Outcomes: - renal function (serum creatinine); - proteinuria
Secondary Outcomes: - side effects; - relapse rate
Expected Total Enrollment:  30

Study start: May 2002

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • membranous nephropathy
  • serum creatinine > 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
  • NSAIDs

Location Information


Netherlands
      Department of Nephrology Radboud University Nijmegen Medical Centre, Nijmegen,  6500 HB,  Netherlands

Study chairs or principal investigators

Jack F Wetzels, MD,  Principal Investigator,  Radboud University   

More Information

Study ID Numbers:  RUNMN02
Last Updated:  August 25, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00135967
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-08-30


Source: ClinicalTrials.gov
Cache Date: August 31, 2005

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Page Updated: June 1, 2005
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