Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental

NCT ID: NCT00404833

Last Updated: 2013-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glomerulonephritis, Membranous Glomerulosclerosis, Focal

Keywords

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idiopathic membranous nephropathy or focal segmental glomerulosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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prednisolone and mycophenolate mofetil

Intervention Type DRUG

prednisolone and chlorambucil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* abnormal urine protein excretion and biopsy-proven idiopathic membranous nephropathy or focal segmental glomerulosclerosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role collaborator

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Daniel TM Chan, Prof

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Queen Mary Hospital

Locations

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Queen Mary Hospital

Hong Kong, , China

Site Status

Countries

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China

References

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Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.

Reference Type DERIVED
PMID: 35224732 (View on PubMed)

von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.

Reference Type DERIVED
PMID: 34778952 (View on PubMed)

Other Identifiers

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HARECCTR0500005

Identifier Type: -

Identifier Source: secondary_id

EC1838-02

Identifier Type: -

Identifier Source: org_study_id