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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00135967
Other study ID # RUNMN02
Secondary ID
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
Est. completion date
Est. primary completion date
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


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
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