Mycophenolate Mofetil in Membranous Nephropathy

Radboud University Medical Center30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glomerulonephritis, Membranous

Interventions

mycophenolate mofetil orally 1000 mg twice a day (BID)DRUG

prednisone 0,5 mg/kg orally on alternate daysDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (1)

Department of Nephrology Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Outcomes

Primary Outcomes

renal function (serum creatinine)

proteinuria

Secondary Outcomes

side effects

relapse rate

Data from ClinicalTrials.gov

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