Rituximab Therapy for Patients on Kidney Transplant Waiting List With Positive Donor Specific Crossmatch to Living Donor
Summary
Primary Objectives: * Conversion of a positive donor specific cross-match to a living donor to a negative cross-match thereby allowing successful renal transplantation. * Transplant success or failure following the desensitization protocol. * Determination of the effect of rituximab on the kinetics of donor specific antibodies (DSA). * Determination of the effect of rituximab on the kinetics of B-cell subpopulations in peripheral blood and/or secondary lymphoid organs (lymph node biopsies at time of transplant, if available) in both responders and non-responders using flow cytometry and/or immunohistochemistry. Secondary Objectives: -Decrease in incidence of humoral rejection to less than 50 % at 1 year.
Timeline
- Start
- 2007-03
- Primary completion
- 2007-09
- Completion
- 2007-09
Outcome
Outcome not reported
Stopped: “Protocol to be revised”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |