Focal Segmental Glomerulosclerosis Clinical Trial (FSGS-CT)

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Results first posted: Sep 18, 2026v15 Show 6 more changesShow less
    • Primary endpoint revised
    • Enrollment target: estimated 207 to confirmed 192
    • Primary and study completion dates: Oct 2009 to Nov 2009
    • Interventions: Cyclosporin (Drug), MMF and Dexamethasone (Drug) to Cyclosporin (Drug), Mycophenolate mofetil and Dexamethasone (Drug)
    • Secondary endpoint revised
    • Publications: details revised at 1 of 5 entries
  2. Re-verified, no change to tracked fieldsv14
  3. Trial status: Active, Not Recruiting to Completedv13
  4. 2 versions Re-verified since Feb 4, 2011, no change to tracked fieldsv11-v12
  5. Primary and study completion dates: Oct 2008 to Oct 2009
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary completion date: Oct 2008v9
  2. Interventions: Cyclosporin (CSA) (Drug), Mycophenolate Mofetil (MMF) (Drug) to Cyclosporin (Drug), MMF and Dexamethasone (Drug)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study arms: 0 to 2
    • Collaborators expanded, about 3 words
    v8
  3. Enrollment target: 500 to 207
    • Study site revised
    v7
  4. 4 versions Re-verified since Feb 2, 2006, no change to tracked fieldsv3-v6
  5. Interventions: Cyclosporin (CSA) and Mycophenolate Mofetil (MMF) (Drug) to Cyclosporin (CSA) (Drug), Mycophenolate Mofetil (MMF) (Drug)v2 Show 4 more changesShow less
    • Secondary endpoint revised
    • Eligibility criteria shortened, about 3 words
    • Study description shortened, about 5 words
    • Study title expanded, about 2 words
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The FSGS Clinical Trial is a multi-center, prospective, controlled, open label randomized trial designed to determine if treatment with mycophenolate mofetil (MMF) in conjunction with pulse steroids is superior to treatment with Cyclosporine-A (CSA) in inducing remission from proteinuria over 12 months.
Trial Details
NCT Number NCT00135811
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators: The Cleveland Clinic
Conditions
(from sponsor)		 Glomerulosclerosis, Focal
Related terms Glomerulosclerosis, Focal Segmental
Enrollment 192 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov