Mycophenolate Mofetil in Membranous Nephropathy

NCT ID: NCT00135967

Last Updated: 2005-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glomerulonephritis, Membranous

Keywords

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membranous nephropathy mycophenolate mofetil cyclophosphamide prednisone

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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mycophenolate mofetil orally 1000 mg twice a day (BID)

Intervention Type DRUG

prednisone 0,5 mg/kg orally on alternate days

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Jack F Wetzels, MD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Department of Nephrology Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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Branten AJ, du Buf-Vereijken PW, Vervloet M, Wetzels JF. Mycophenolate mofetil in idiopathic membranous nephropathy: a clinical trial with comparison to a historic control group treated with cyclophosphamide. Am J Kidney Dis. 2007 Aug;50(2):248-56. doi: 10.1053/j.ajkd.2007.05.015.

Reference Type DERIVED
PMID: 17660026 (View on PubMed)

Other Identifiers

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RUNMN02

Identifier Type: -

Identifier Source: org_study_id