drugset / Trial / NCT04827979
Daratumumab and Belatacept for Desensitization
Phase 1/2
Active not recruiting
19 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Bristol-Myers Squibb · collabImmune Tolerance Network (ITN) · collabPPD Development, LP · collabRho Federal Systems Division, Inc. · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
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 on waitlist. The purpose of this study is to find out whether two drugs, daratumumab (Darzalex®), and belatacept (Nulojix®), can make these kidney transplant candidates less sensitized, and make it easier and quicker to find a kidney donor for them.
Timeline
- Start
- 2021-11-01
- Primary completion
- 2027-03-31
- Completion
- 2028-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belatacept | Protein / enzyme biologic | 10 mg/kg | Intravenous |
| Subject | Daratumumab | Monoclonal antibody | 8 mg/kg | Intravenous |
| Subject | Daratumumab | Monoclonal antibody | 16 mg/kg | Intravenous |