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
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • renal function (serum creatinine)
  • proteinuria

Secondary Outcome Measures:
  • side effects
  • relapse rate

Estimated Enrollment: 30
Study Start Date: May 2002
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135967

Locations
Netherlands
Department of Nephrology Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Hoffmann-La Roche
Investigators
Principal Investigator: Jack F Wetzels, MD Radboud University
  More Information

No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00135967     History of Changes
Other Study ID Numbers: RUNMN02
Study First Received: August 25, 2005
Last Updated: December 5, 2005
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
membranous nephropathy
mycophenolate mofetil
cyclophosphamide
prednisone

Additional relevant MeSH terms:
Glomerulonephritis, Membranous
Glomerulonephritis
Kidney Diseases
Autoimmune Diseases
Immune System Diseases
Nephritis
Urologic Diseases
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Mycophenolate mofetil
Mycophenolic Acid
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisone
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors

ClinicalTrials.gov processed this record on October 23, 2014