Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental

Hospital Authority, Hong Kong

Status and phase: Completed; Phase 3

Conditions: Glomerulosclerosis, Focal; Glomerulonephritis, Membranous

Treatments: Drug: prednisolone and chlorambucil; Drug: prednisolone and mycophenolate mofetil

Study type: Interventional

Funder types: Other

Identifiers

NCT00404833

EC1838-02

HARECCTR0500005

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)