Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Ages 18-75

• End-stage renal disease on dialysis

• Panel Reactive Antibody (PRA) > 60%

• Have been evaluated for and are currently listed for deceased donor renal transplantation

Exclusion Criteria:

• Have contraindication to transplantation

• Have contraindication to receiving IVIG

• Have allergy to IVIG

• Have received IVIG for desensitization previously without effect

• Pregnant women or those intending to become pregnant