NCT05027906

Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant

A Phase 1b, Multicenter, Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Eledon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.

Detailed description

This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation. Up to 48 de novo kidney transplant recipients will receive AT-1501 in combination with rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy.

Conditions

• Prevention of Rejection in Kidney Transplant

Interventions

Type	Name	Description
DRUG	AT-1501	Investigative Arm

Timeline

• Start date: 2022-02-18
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2021-08-30
• Last updated: 2025-06-29

Locations

9 sites across 5 countries: United States, Australia, Brazil, Canada, United Kingdom

Regulatory

• FDA-regulated drug study