Mycophenolate Mofetil in Membranous Nephropathy

Glomerulonephritis, Membranous Clinical Trial

Official title:

Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135967
• Other study ID #: RUNMN02
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 25, 2005
• Last updated: December 5, 2005
• Start date: May 2002

Study information

• Verified date: August 2005
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis
• Glomerulonephritis, Membranous
• Kidney Diseases

Intervention

Drug:
• mycophenolate mofetil orally 1000 mg twice a day (BID)

• prednisone 0,5 mg/kg orally on alternate days

• intravenous (i.v.) methylprednisolone 1000 mg, total 9

Locations

Country	Name	City	State
Netherlands	Department of Nephrology Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal function (serum creatinine)
Primary	proteinuria
Secondary	side effects
Secondary	relapse rate