Mycophenolate Mofetil in Membranous Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00135967
• Date of registration: 25/08/2005
• Prospective Registration: No
• Primary sponsor: Radboud University
• Public title: Mycophenolate Mofetil in Membranous Nephropathy
• Scientific title: Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study
• Date of first enrolment: May 2002
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00135967
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Netherlands

Contacts

• Name: Jack F Wetzels, MD
• Affiliation: Radboud University

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Glomerulonephritis, Membranous

Intervention(s)

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

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

Drug: prednisone 0,5 mg/kg orally on alternate days

Primary Outcome(s)

renal function (serum creatinine)

proteinuria

Secondary Outcome(s)

side effects

relapse rate

Secondary ID(s)

RUNMN02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hoffmann-La Roche