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Mycophenolate Mofetil in Membranous Nephropathy

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ClinicalTrials.gov Identifier: NCT00135967
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : December 6, 2005
Hoffmann-La Roche
Information provided by:
Radboud University Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
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 Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study
Study Start Date : May 2002

Primary Outcome Measures :
  1. renal function (serum creatinine)
  2. proteinuria

Secondary Outcome Measures :
  1. side effects
  2. relapse rate

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135967

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Department of Nephrology Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University Medical Center
Hoffmann-La Roche
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Principal Investigator: Jack F Wetzels, MD Radboud University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00135967    
Other Study ID Numbers: RUNMN02
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: December 6, 2005
Last Verified: August 2005
Keywords provided by Radboud University Medical Center:
membranous nephropathy
mycophenolate mofetil
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, Membranous
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action