Mycophenolate Mofetil in Membranous Nephropathy

Radboud University Medical Center

Status and phase: Completed; Phase 3; Phase 2

Conditions: Glomerulonephritis, Membranous

Treatments: 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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00135967

RUNMN02

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)