drugset / Trial / NCT01025193

Desensitization With Belimumab in Sensitized Patients Awaiting Kidney Transplant

NCT01025193

NaSingle-groupOpen-labelTreatment

Summary

If subjects are listed for kidney transplant and are considered sensitized, this means they have a high amount of antibodies in their blood that could react to a kidney transplant offered for them. Antibodies are protein substances made by the body that fight anything that the body considers as a threat to it, such as infection or a kidney transplant. Sensitization may be due to prior transplants, pregnancy, or blood transfusions. Being sensitized can increase the subject's kidney transplant waiting time as it is more difficult to find a suitable kidney transplant for them that their antibodies will not react to. The purpose of this research study is to see if giving the investigational drug belimumab up to one year pre-transplant can de-sensitize the subjects, or decrease the amount of antibodies in their blood. This may help make the subjects eligible to receive a kidney transplant more quickly. If after receiving belimumab, the subjects are compatible with a donor kidney offered and are medically suitable for transplant at that time, a kidney transplant will be performed.

Timeline

Start
2010-02
Primary completion
2011-10
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Belimumab Monoclonal antibody 10 mg/kg Intravenous

Indications

No indication recorded.