NCT00404833CompletedPhase 3

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)

Hospital Authority, Hong Kong1 site in 1 country16 target enrollmentStarted: January 1, 2003Last updated: October 23, 2013

Conditions

Drugs

Trial Snapshot

Phase: Phase 3
Status: Completed
Sponsor
Enrollment: 16
Locations: 1
Primary Endpoint: Proteinuria

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to 65 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•abnormal urine protein excretion and biopsy-proven idiopathic membranous nephropathy or focal segmental glomerulosclerosis

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Proteinuria

Secondary Outcomes

Adverse effects

Investigators

Sponsor

Hospital Authority, Hong Kong

Sponsor Class

Other Gov

Study Sites (1)

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