Rituximab Treatment of Focal Segmental Glomerulosclerosis

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT00550342
Phase
PHASE2
Status
Withdrawn

Conditions

  • Focal Segmental Glomerulosclerosis (FSGS)

Eligibility Criteria

Sex
ALL
Age
5 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — DRUG
    375 mg/m2 intravenously for 4 doses

Study Details

The purpose of this study is to determine whether the approved drug, rituximab, is effective in the treatment of focal segmental glomerulosclerosis (FSGS)

Key Dates

Start date
Jan 31, 2008
Status verified
Apr 2012
Primary completion
Dec 31, 2009
Completion
Dec 31, 2009

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Rituximab (375 mg/m2) will be administered intravenously as per current package label in a facility capable of handling infusion reactions. Subjects would be pre dosed with diphenhydramine and acetaminophen. Solu-Medrol, 1.5 mg/kg would be dosed 1 hour prior to the first dose of rituximab. Three subsequent doses of rituximab will be given at weekly intervals.

Primary Outcome Measure

The primary endpoint will be resolution of proteinuria defined as a Up/C ratio of <0.2. [ Time Frame: One year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana UniversityIndianapolisIndiana46202-

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By research site
Indiana University· Indianapolis, IN

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