Study for Desensitization of Chronic Kidney Disease Adult Patients in Need of a Kidney Transplant Who Are Highly Sensitized to Human Leukocyte Antigen

• Status: Not yet recruiting
• Trial end date: 2025-03-21

Summary

The primary objective of the study is to assess the safety and tolerability of REGN5459 (Part A) or REGN5458 (Part B) as monotherapy in patients with chronic kidney disease (CKD) who need kidney transplantation and are highly sensitized to human leukocyte antigen (HLA).

The secondary objectives of the study are to determine/assess the following for REGN5459 (Part A) or REGN5458 (Part B):

• Dose regimen(s) that result in a clinically meaningful reduction of anti-HLA alloantibody levels

• Effect on calculated panel-reactive antibody (cPRA) levels

• Time to maximal and clinically meaningful reduction in anti-HLA alloantibody levels

• Duration of the effect of study drug on the reduction of anti-HLA alloantibodies

• Effect on circulating immunoglobulin (Ig) classes (isotypes)

• Pharmacokinetics (PK) properties

• Immunogenicity

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: Regeneron Pharmaceuticals