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Focal Segmental Glomerulosclerosis Clinical Trial (FSGS-CT)

NCT00135811 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2012-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Glomerulosclerosis, Focal

Interventions

DRUG

Cyclosporin

Participants assigned to this group will initiate treatment with CSA, 5-6 mg/kg per day with a 250 mg/day maximum starting dose, divided into two daily doses. The CSA dose will be adjusted based on drug levels determined at specified study visits in order to achieve a 12-hour trough concentration in the therapeutic range of 100-250 ng/ml.

DRUG

MMF and Dexamethasone

MMF, 25-36 mg/kg per day with a maximum dose of 2 g/day divided into two daily doses. The dose range reflects the use of fixed size (250 mg) capsules and application of defined daily doses to specific weight ranges (see Table below). In younger children or those participants who are unable to swallow capsules, a liquid formulation will be used to provide 36 mg/kg per day to a maximum of 2 g per day. The starting MMF dose will be 0.5-0.67 of the full dose for 2 weeks before advancing to the full dose for the duration of the 12-month treatment period. Dexamethasone, 0.9 mg/kg per dose, with a maximum dose of 40 mg

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Aaron Friedman, MD · University of Minnesota

  • Marva Moxey-Mims, MD, FAAP · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00135811 on ClinicalTrials.gov