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Clinical trial

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

ID
Name
AT-1501-K207
Description
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
Trial arms
Trial start
2023-08-30
Estimated PCD
2025-03-01
Trial end
2025-03-01
Status
Recruiting
Phase
Early phase I
Treatment
AT-1501
IV infusions of AT-1501 20 mg/kg over 1 hour.
Arms:
Investigative
Other names:
Tegoprubart
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.
Arms:
Comparator
Size
120
Primary endpoint
eGFR at 12 months
Assessed from date of transplant through Day 364 (Month 12)
Eligibility criteria
Inclusion Criteria: * Male or female ≥ 18 years of age * Recipient of their first kidney transplant from a living or deceased donor * Agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug Exclusion Criteria: * Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen * Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies * Currently treated with corticosteroids other than topical or inhaled corticosteroids * Will receive a kidney with an anticipated cold ischemia time of \> 30 hours * Will receive a kidney from a donor that meets any of the following: * 5a. Donation after Cardiac Death (DCD) criteria; Or * 5b. Kidney Donor Profile Index (KDPI) of \> 85%; Or * 5c. Is blood group (ABO) incompatible * Medical conditions that require chronic use of systemic corticosteroids or other immunosuppressants * History of a thromboembolic event, known hypercoagulable state, or condition requiring long term anticoagulation * Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2024-04-26

1 organization

2 products

1 indication

Product
AT-1501
Indication
Kidney Transplant Rejection
Organization
Eledon Pharmaceuticals
Product
Tacrolimus