NCT05983770

Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

AT-1501-K207: BESTOW: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Eledon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.

Detailed description

This study is a randomized, multicenter, open-label, active control study to evaluate the safety and efficacy of AT-1501 compared with tacrolimus in the prevention of rejection in patients undergoing kidney transplantation. Up to 120 de novo kidney transplant recipients will receive rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy, and will be randomized 1:1 to receive either AT-1501 or tacrolimus.

Conditions

• Kidney Transplant Rejection

Interventions

Type	Name	Description
DRUG	AT-1501	IV infusions of AT-1501 20 mg/kg over 1 hour.
DRUG	Tacrolimus	Tacrolimus will be administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter.

Timeline

• Start date: 2023-08-30
• Primary completion: 2025-09-11
• Completion: 2025-09-25
• First posted: 2023-08-09
• Last updated: 2025-10-29

Locations

43 sites across 7 countries: United States, Australia, Brazil, Canada, France, Germany, Spain

Regulatory

• FDA-regulated drug study