Back to resultsMycophenolate Mofetil in Membranous Nephropathy and Focal Segmental
Primary Purpose
Glomerulonephritis, Membranous, Glomerulosclerosis, Focal
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
prednisolone and mycophenolate mofetil
prednisolone and chlorambucil
Sponsored by
About this trial
This is an interventional treatment trial for Glomerulonephritis, Membranous focused on measuring idiopathic membranous nephropathy or focal segmental glomerulosclerosis
Eligibility Criteria
Inclusion Criteria:
- abnormal urine protein excretion and biopsy-proven idiopathic membranous nephropathy or focal segmental glomerulosclerosis
Sites / Locations
- Queen Mary Hospital
Outcomes
Primary Outcome Measures
Proteinuria
Secondary Outcome Measures
Adverse effects
Full Information
NCT ID
NCT00404833
First Posted
November 27, 2006
Last Updated
October 22, 2013
Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00404833
Brief Title
Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental
Official Title
A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Conventional Immunosuppressive Treatment on Proteinuria in Idiopathic Membranous Nephropathy (MN) and Focal Segmental Glomerulosclerosis (FSGS)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong
4. Oversight
5. Study Description
Brief Summary
This is a prospective randomized open-label pilot study to investigate the effect of mycophenolate mofetil treatment in patients with abnormal urine protein excretion due to membranous nephropathy (MN) or focal segmental glomerulosclerosis (FSGS). The change in urine protein excretion will be the primary outcome studied. The treatment regimen comprising prednisolone and mycophenolate mofetil will be compared with prednisolone and chlorambucil in MN, and compared with prednisolone in FSGS. The study duration will be 12 months for each patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glomerulonephritis, Membranous, Glomerulosclerosis, Focal
Keywords
idiopathic membranous nephropathy or focal segmental glomerulosclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
prednisolone and mycophenolate mofetil
Intervention Type
Drug
Intervention Name(s)
prednisolone and chlorambucil
Primary Outcome Measure Information:
Title
Proteinuria
Secondary Outcome Measure Information:
Title
Adverse effects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria:
abnormal urine protein excretion and biopsy-proven idiopathic membranous nephropathy or focal segmental glomerulosclerosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel TM Chan, Prof
Organizational Affiliation
Department of Medicine, Queen Mary Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35224732
Citation
Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
Results Reference
derived
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
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Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental
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