drugset / Trial / NCT03591380

CAMPath and BELimumab for Transplant Tolerance in Sensitized Kidney Transplant Recipients

NCT03591380

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this research study is to determine whether kidney transplant recipients who receive belimumab (Benlysta®), combined with the standard of care medications for kidney transplant recipients, is safe and effective in helping prevent new donor specific antibodies (DSA) after transplantation. The presence of DSA increases the risk that the kidney transplant recipient's body will reject the new kidney. The investigators are doing this research because it is estimated that greater than 50% of kidney transplant failures are attributed to antibodies produced in the body, that attack the transplanted organ as a foreign object. DSA produced in the body after a kidney transplant, is thought to occur in 20-50% of patients and is associated with a low likelihood that the organ recipient's body will accept the new kidney. A major unmet need in the kidney transplant area are safe and effective therapies to prevent DSA after transplantation.

Timeline

Start
2019-05-14
Primary completion
2021-12-03
Completion
2021-12-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Belimumab Monoclonal antibody 10 mg/kg Intravenous

Indications

No indication recorded.