Some kidney transplant candidates have a very low chance of getting a kidney transplant because their immune systems are "highly sensitized" to most kidney donors. Being "highly sensitized" means that they will likely have to wait a long time (more than 5 years) before an acceptable donor is found for them or, they never receive a compatible donor, and die while on the kidney transplant waitlist. The purpose of this study is to find out whether two drugs, carfilzomib (Kyprolis®),and belatacept (Nulojix®), can make these kidney transplant candidates less sensitized, and make it easier and quicker to find a kidney donor for them.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Proportion of subjects who do not meet a stopping rule for safety and remain free of all of the following through 26 weeks (Cohort 1) after starting treatment or until receiving a transplant, whichever occurs earlier.
Timeframe: Up to 26 weeks post treatment initiation
Proportion of subjects who do not meet a stopping rule for safety and remain free of all of the following through Week 24 (Cohort 2) post treatment initiation or until receiving a transplant, whichever occurs earlier.
Timeframe: Up to 24 weeks post treatment initiation
Proportion of subjects who achieve any one of the following compared to Baseline - Cohort 1
Timeframe: Baseline (Visit 0) to Week 20 post treatment initiation
Proportion of subjects who meet any one of the pre-specified events detailed in the outcome description: from Baseline to Week 24 post treatment initiation - Cohort 2
Timeframe: Baseline (Visit 0) to Week 24 post treatment initiation