Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates
Stopped early · Phase 2
Conditions studied: Kidney Failure
In brief
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.
Key facts
- Study ID
- NCT00986947
- Run by
- Johns Hopkins University
- People needed
- 20
- Starts
- 2009-09-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2017-06-01
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Johns Hopkins Medical Institutions — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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