drugset / Trial / NCT00986947

Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates

NCT00986947

Phase 2 Terminated 20 enrolled Johns Hopkins University
NaSingle-groupOpen-labelTreatment

Summary

Some patients who need kidney transplants have high levels of antibodies that make them incompatible with most potential deceased donor kidney offers. These patients are considered highly-sensitized and are very difficult to transplant because the likelihood that they will receive a compatible organ is very low. There are some medications and procedures that can decrease the antibody levels and this can increase the chance of finding a compatible donor for these patients. In this study the investigators will give two medications (IVIg and Rituximab) to highly-sensitized patients who are on the waiting list for a deceased donor kidney transplant. After the investigators administer these medications, the investigators will continue to check for compatibility as organ offers are received. If a compatible organ offer is received, the investigators will perform the transplant using that organ. The investigators hypothesize that these medications will lower antibody levels and increase the chance that a these patients are able to receive a compatible kidney transplant.

Timeline

Start
2009-09
Primary completion
2011-07
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 2 g/kg
Subject Rituximab Monoclonal antibody 375 mg/m2

Indications