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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

Page last updated: August 23, 2015

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