NCT07290777

VEL-101 to Prevent Rejection After Kidney Transplantation

A Phase 2, Randomized, Partially Blinded, Controlled, Dose-ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of VEL-101 in Kidney Transplant Recipients.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Veloxis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of VEL-101 compared with tacrolimus in patients undergoing kidney transplantation.

Detailed description

This study is a randomized, multicenter, partially blinded, active control study to evaluate the safety and effectiveness of VEL-101 compared with tacrolimus in the prevention of rejection in patients undergoing kidney transplantation. Up to 120 de novo kidney transplant recipients will receive rATG with corticosteroids (CS), and mycophenolate as maintenance therapy, and will be randomized 1:1:1 to receive either VEL-101 (low dose or high dose) or tacrolimus.

Conditions

• Transplantation, Kidney

Interventions

Type	Name	Description
DRUG	Tacrolimus (TAC)	Tacrolimus Immediate Release in addition to SOC
DRUG	VEL-101	VEL-101 in addition to SOC

Timeline

• Start date: 2026-07-01
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2025-12-18
• Last updated: 2025-12-18

Regulatory

• FDA-regulated drug study