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NCT00404833 Clinical Trial

Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental

Glomerulonephritis, Membranous Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00404833
Other study ID # EC1838-02
Secondary ID HARECCTR0500005
Status Completed
Phase Phase 3
First received November 27, 2006
Last updated October 22, 2013
Start date January 2003
Est. completion date December 2006

Study information
Verified date October 2013
Source Hospital Authority, Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• prednisolone and mycophenolate mofetil

• prednisolone and chlorambucil

Locations
Country Name City State
China Queen Mary Hospital Hong Kong

Sponsors (2)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proteinuria
Secondary Adverse effects
See also
  Status Clinical Trial Phase
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Completed NCT00199628 - Research Network for Neonatal Diseases Induced by Tissular Fetomaternal Alloimmunization
Active, not recruiting NCT05656963 - The Influencing Factors and Mechanism of High Incidence of Thrombotic Events in Patients With MN and DKD
Completed NCT04145440 - Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN) Phase 1/Phase 2
Terminated NCT04154787 - Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous Nephropathy Phase 2
Completed NCT00404794 - A Study to Compare Mycophenolate Mofetil and Tacrolimus in the Treatment of Membranous Lupus Nephritis Phase 3
Completed NCT03880643 - Rituximab in Refractory Primary Membranous Nephropathy
Not yet recruiting NCT05797051 - Application of Hyperspectral Imaging in the Diagnosis of Glomerular Diseases
Completed NCT00135967 - Mycophenolate Mofetil in Membranous Nephropathy Phase 2/Phase 3
Completed NCT00843856 - Mycophenolate Mofetil and Tacrolimus Versus Tacrolimus for the Treatment of Idiopathic Membranous Glomerulonephritis Phase 4
Recruiting NCT01282073 - Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy Phase 3
Recruiting NCT05914155 - Clinical Study of Rituximab for the Treatment for Idiopathic Membranous Nephropathy With Nephrotic Syndrome Phase 3
Completed NCT00135954 - Treatment of Patients With Idiopathic Membranous Nephropathy Phase 3
Completed NCT01610492 - A Study of Belimumab in Idiopathic Membranous Glomerulonephropathy Phase 2
Active, not recruiting NCT03018535 - Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy Phase 3
Withdrawn NCT01762852 - Efficacy and Safety Study of Intravenous Belimumab Versus Placebo in Subjects With Idiopathic Membranous Nephropathy Phase 2

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