Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental
Information source: Hospital Authority, Hong Kong
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glomerulonephritis, Membranous; Glomerulosclerosis, Focal
Intervention: prednisolone and mycophenolate mofetil (Drug); prednisolone and chlorambucil (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Hospital Authority, Hong Kong Official(s) and/or principal investigator(s): Daniel TM Chan, Prof, Principal Investigator, Affiliation: Department of Medicine, Queen Mary Hospital
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proteinuria
Secondary outcome: Adverse effects
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- abnormal urine protein excretion and biopsy-proven idiopathic membranous nephropathy
or focal segmental glomerulosclerosis
Locations and Contacts
Queen Mary Hospital, Hong Kong, China
Additional Information
HAREC Clinical Trial Registry
Starting date: January 2003
Last updated: October 22, 2013
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