Mycophenolate Mofetil in Membranous Nephropathy
Primary Purpose
Glomerulonephritis, Membranous
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Glomerulonephritis, Membranous focused on measuring membranous nephropathy, mycophenolate mofetil, cyclophosphamide, prednisone
Eligibility 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)
Sites / Locations
- Department of Nephrology Radboud University Nijmegen Medical Centre
Outcomes
Primary Outcome Measures
renal function (serum creatinine)
proteinuria
Secondary Outcome Measures
side effects
relapse rate
Full Information
NCT ID
NCT00135967
First Posted
August 25, 2005
Last Updated
December 5, 2005
Sponsor
Radboud University Medical Center
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT00135967
Brief Title
Mycophenolate Mofetil in Membranous Nephropathy
Official Title
Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
Collaborators
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glomerulonephritis, Membranous
Keywords
membranous nephropathy, mycophenolate mofetil, cyclophosphamide, prednisone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
mycophenolate mofetil orally 1000 mg twice a day (BID)
Intervention Type
Drug
Intervention Name(s)
prednisone 0,5 mg/kg orally on alternate days
Intervention Type
Drug
Intervention Name(s)
intravenous (i.v.) methylprednisolone 1000 mg, total 9
Primary Outcome Measure Information:
Title
renal function (serum creatinine)
Title
proteinuria
Secondary Outcome Measure Information:
Title
side effects
Title
relapse rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack F Wetzels, MD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nephrology Radboud University Nijmegen Medical Centre
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
17660026
Citation
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.
Results Reference
derived
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Mycophenolate Mofetil in Membranous Nephropathy
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