Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental
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)
2 other identifiers
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2003
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 27, 2006
CompletedFirst Posted
Study publicly available on registry
November 29, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedOctober 23, 2013
October 1, 2013
November 27, 2006
October 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proteinuria
Secondary Outcomes (1)
Adverse effects
Interventions
Eligibility Criteria
You may qualify if:
- abnormal urine protein excretion and biopsy-proven idiopathic membranous nephropathy or focal segmental glomerulosclerosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Authority, Hong Konglead
- The University of Hong Kongcollaborator
Study Sites (1)
Queen Mary Hospital
Hong Kong, China
Related Publications (2)
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.
PMID: 35224732DERIVEDvon 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.
PMID: 34778952DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel TM Chan, Prof
Department of Medicine, Queen Mary Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
November 27, 2006
First Posted
November 29, 2006
Study Start
January 1, 2003
Study Completion
December 1, 2006
Last Updated
October 23, 2013
Record last verified: 2013-10