Effects of Rituximab and Mycophenolate Mofetil (MMF) on Highly Sensitized Patients Awaiting Renal Transplant

Sponsor
University of Washington
Study ID
NCT00446251
Phase
PHASE2
Status
Completed

Conditions

  • Diabetic Nephropathies
  • Glomerulonephritis, IGA
  • Hypertension, Renal
  • Kidney Failure, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab dose is 1,000 mg given as an IV infusion every two weeks for 2 doses (days 1 and 15).
  • Mycophenolate mofetil (MMF) — DRUG
    Cellcept is continued from prior study, taken 500 - 1,000 mg BID, P.O.

Study Details

This is a 12-month phase 2, prospective, open label study to evaluate the effect of rituximab with mycophenolate mofetil (MMF)on the PRA of 14 highly sensitized patients who just completed an 8 month trial of MMF treatment alone. PRA values obtained at study enrollment and at 6 and 12 months on combined therapy as well as the rates of transplant will be compared and evaluated using descriptive analysis.

Key Dates

Start date
Dec 31, 2006
Status verified
Mar 2010
Primary completion
Apr 30, 2008
Completion
Dec 31, 2008

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

The Number of Subjects Who Experience a Decrease in Their Panel of Reactive Antibodies (PRA) at 6 Months Post Rituximab Infusion. [ Time Frame: Month 6 from start of study ]

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