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CompletedNCT00404833Updated Oct 23, 2013

Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental

A Phase 3 interventional study of prednisolone and mycophenolate mofetil and prednisolone and chlorambucil in Glomerulonephritis, Membranous and Glomerulosclerosis, Focal, sponsored by Hospital Authority, Hong Kong. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-10-23.

Sponsored by Hospital Authority, Hong Kong · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Glomerulonephritis, Membranous
  • Glomerulosclerosis, Focal

Keywords

  • idiopathic membranous nephropathy or focal segmental glomerulosclerosis
03

In context

Glomerulonephritis, Membranous

119 studies on the registry are indexed under Glomerulonephritis, Membranous; 40 are open to participants now.

This study's planned enrollment of 16 is below the median of 31 across 83 interventional studies indexed under Glomerulonephritis, Membranous.

Browse Glomerulonephritis, Membranous studies →

Lead sponsor

Hospital Authority, Hong Kong is the lead sponsor of 79 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All

Eligibility criteria

Inclusion Criteria:

  • abnormal urine protein excretion and biopsy-proven idiopathic membranous nephropathy or focal segmental glomerulosclerosis
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (estimated)

Interventions

06

What researchers measure

Primary outcomes

  1. Proteinuria

Secondary outcomes

  1. Adverse effects

07

Study locations

1 site
  • Queen Mary Hospital
    Hong Kong, China
08

References and documents

Publications

  • 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. PubMed 35224732 ↗
  • 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. PubMed 34778952 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2003 and a completion of Dec 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2006
First posted
Nov 29, 2006
Start
Jan 2003
CompletionActual
Dec 2006
Last update
Oct 23, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00404833
Lead sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong
First posted
Nov 29, 2006
Start date
Jan 2003
Completion
Dec 2006
Last update
Oct 23, 2013

Study contacts

Daniel TM Chan, Prof
principal investigator · Department of Medicine, Queen Mary Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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