Back to resultsTreatment of Patients With Idiopathic Membranous Nephropathy
Primary Purpose
Glomerulonephritis, Membranous
Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Cyclophosphamide and steroids
Sponsored by
About this trial
This is an interventional treatment trial for Glomerulonephritis, Membranous focused on measuring membranous nephropathy, cyclophosphamide, prednisone
Eligibility Criteria
Inclusion Criteria: Idiopathic membranous nephropathy Serum creatinine < 1.5 mg/dl Nephrotic syndrome Exclusion Criteria: Infection Instable angina Systemic disease Pregnancy Renal vein thrombosis Prior therapy with immunosuppressant agents Liver dysfunction Use of nonsteroidal anti-inflammatory drugs (NSAIDs)
Sites / Locations
- Department of Nephrology Radboud University Nijmegen Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
late intervention
early intervention
Arm Description
cyclophosphamide and steroids started at time of renal insufficiency
immediate start of cyclophosphamide and steroids
Outcomes
Primary Outcome Measures
renal function (serum creatinine)
proteinuria
side effects
Secondary Outcome Measures
Full Information
NCT ID
NCT00135954
First Posted
August 25, 2005
Last Updated
January 27, 2014
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00135954
Brief Title
Treatment of Patients With Idiopathic Membranous Nephropathy
Official Title
Treatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
July 1997 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
5. Study Description
Brief Summary
Patients with idiopathic membranous nephropathy at risk for renal failure can be identified in an early stage by measuring urinary low molecular weight proteins and urinary immunoglobulin G (IgG). This study evaluates the possible benefit of early start of immunosuppressive therapy in these high-risk patients.
Detailed Description
Inclusion Criteria:
patients with idiopathic membranous nephropathy
nephrotic syndrome
normal renal function (serum creatinine [Screat] < 1.5 mg/dl)
elevated urinary beta2-microglobulin and IgG
Immunosuppressive therapy consisting of:
cyclophosphamide 1.5 mg/kg/day for 12 months
prednisone orally, 0.5 mg/kg on alternate days for 6 months
i.v. methylprednisolone 1000 mg on days 1,2,3, 60,61,62, 120,121,122
Study Groups:
early: immediate start of immunosuppressive therapy at the time patient is identified as high-risk
late: start of therapy after deterioration of renal function (increase of Screat > 25% and Screat > 1.5 mg/dl)
Main Outcome Parameters:
serum creatinine
remission of proteinuria
period of nephrotic proteinuria
major side effects: hospitalisations, infections
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glomerulonephritis, Membranous
Keywords
membranous nephropathy, cyclophosphamide, prednisone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
late intervention
Arm Type
Other
Arm Description
cyclophosphamide and steroids started at time of renal insufficiency
Arm Title
early intervention
Arm Type
Experimental
Arm Description
immediate start of cyclophosphamide and steroids
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide and steroids
Other Intervention Name(s)
prednisolone, endoxan
Intervention Description
comparison of difference in time of start of therapy
Primary Outcome Measure Information:
Title
renal function (serum creatinine)
Title
proteinuria
Title
side effects
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:
Idiopathic membranous nephropathy
Serum creatinine < 1.5 mg/dl
Nephrotic syndrome
Exclusion Criteria:
Infection
Instable angina
Systemic disease
Pregnancy
Renal vein thrombosis
Prior therapy with immunosuppressant agents
Liver dysfunction
Use of nonsteroidal anti-inflammatory drugs (NSAIDs)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack F Wetzels, MD, PhD
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
34778952
Citation
von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
Results Reference
derived
PubMed Identifier
19666912
Citation
Hofstra JM, Branten AJ, Wirtz JJ, Noordzij TC, du Buf-Vereijken PW, Wetzels JF. Early versus late start of immunosuppressive therapy in idiopathic membranous nephropathy: a randomized controlled trial. Nephrol Dial Transplant. 2010 Jan;25(1):129-36. doi: 10.1093/ndt/gfp390. Epub 2009 Aug 8.
Results Reference
derived
Learn more about this trial
Treatment of Patients With Idiopathic Membranous Nephropathy
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