Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

Sponsor

Eledon Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05983770

Collaborator

(none)

120

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant Rejection	Drug: AT-1501 Drug: Tacrolimus	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Investigative AT-1501 monoclonal antibody targeting CD40L given as an IV infusion	Drug: AT-1501 IV infusions of AT-1501 20 mg/kg over 1 hour. Other Names: Tegoprubart
Active Comparator: Comparator Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter	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.

Arm

Intervention/Treatment

Experimental: Investigative

AT-1501 monoclonal antibody targeting CD40L given as an IV infusion

Drug: AT-1501

IV infusions of AT-1501 20 mg/kg over 1 hour.

Other Names:

Tegoprubart

Active Comparator: Comparator

Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter

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.

Outcome Measures

Primary Outcome Measures

eGFR at 12 months [Assessed from date of transplant through Day 364 (Month 12)]
Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant

Secondary Outcome Measures

NODAT at 12 months post-transplant [Assessed from date of transplant through Day 364 (Month 12]
The proportion of new onset diabetes after transplant (NODAT) at 12 months post-transplant
The proportion of patient and graft survival at 12 months post-transplant [Assessed from date of transplant through Day 364 (Month 12)]
Patient and graft survival are defined as either A) Death, B) re-transplantation or C) Requirement for regular dialysis
BPAR-free patient and graft survival at 12 months post-transplant [The proportion of BPAR-free patient and graft survival at 12 months post-transplant]
Assessed from date of transplant through Day 364 (Month 12)
BPAR at 12 months [Assessed from date of transplant through Day 364 (Month 12)]
The proportion of BPAR at 12 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 6. Medical conditions that require chronic use of systemic corticosteroids or other immunosuppressants 7. History of a thromboembolic event, known hypercoagulable state, or condition requiring long term anticoagulation 8. Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening