Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
NCT05983770 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127
Last updated 2025-10-29
Summary
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
Conditions
- Kidney Transplant Rejection
Interventions
- DRUG
-
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.
- DRUG
-
AT-1501
IV infusions of AT-1501 20 mg/kg over 1 hour.
Sponsors & Collaborators
-
Eledon Pharmaceuticals
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-30
- Primary Completion
- 2025-09-11
- Completion
- 2025-09-25
- FDA Drug
- Yes
Countries
- United States
- Australia
- Brazil
- Canada
- France
- Germany
- Spain
Study Locations
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