At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 14 enrolled

Drug / intervention

Rituximab +1 moredrug

Likely dose

Rituximab 1,000 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00446251

NCT00446251Phase 2Completed

Compare CT.gov

The Highly Sensitized Patients: Effects of Rituximab and Mycophenolate Mofetil (MMF) On Anti-Human Leukocyte Antigen (HLA) Antibody Levels In Patients Awaiting Cadaveric Renal Transplant.

University of Washington·interventional·Posted Mar 12, 2007·Updated Apr 6, 2010

In Brief

A Phase 2 clinical trial evaluating Rituximab and Mycophenolate mofetil (MMF) for Kidney Failure, Chronic and 3 related conditions. Completed, enrolled 14 participants.

Detailed Summary

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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsKidney Failure, Chronic, Diabetic Nephropathies, Glomerulonephritis, IGA, Hypertension, Renal

Countries--

CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartDec 2006

First PostedMar 2007

Primary CompletionApr 2008

Study CompletionDec 2008

TodayJul 2026

First PostedMar 12, 2007

Enrollment StartDec 1, 2006

Primary CompletionApr 1, 2008

Study CompletionDec 1, 2008

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 19.3 years ago

Interventions

Rituximabdrug

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.