drugset / Trial / NCT07683975
Infliximab for Immune Checkpoint Inhibitor Associated AKI
Phase 4
Not yet recruiting
44 enrolled
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multi-center, 1:1 randomized pilot study examining the efficacy and safety of infliximab 5mg/kg x 1 paired with 2 weeks of prednisone 1mg/kg per day for 2 weeks versus standard-of-care glucocorticoid therapy (prednisone 1mg/kg/day x 2 weeks followed by a 4 week taper) on the rate and speed of renal recovery from immune checkpoint inhibitor-associated AKI.
Timeline
- Start
- 2026-07-16
- Primary completion
- 2029-01-15
- Completion
- 2029-07-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Infliximab | Monoclonal antibody | 5 mg/kg | — |
| Subject | Prednisone | Other / unclassified | 1 mg/kg | Oral |