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Completed

NCT Number: NCT05983770

Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

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

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Key information

Conditions

Kidney Transplant Rejection Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Adelaide Hospital, Adelaide, South Australia, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AT-1501

Drug

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

Other names: Tegoprubart

Tacrolimus

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.

Primary outcomes

  1. eGFR at 12 months

    Time frame: Assessed from date of transplant through Day 364 (Month 12)

    Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant

Secondary outcomes

  1. NODAT at 12 months post-transplant

    Time frame: Assessed from date of transplant through Day 364 (Month 12

    The proportion of new onset diabetes after transplant (NODAT) at 12 months post-transplant

  2. The proportion of patient and graft survival at 12 months post-transplant

    Time frame: 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

  3. BPAR-free patient and graft survival at 12 months post-transplant

    Time frame: The proportion of BPAR-free patient and graft survival at 12 months post-transplant

    Assessed from date of transplant through Day 364 (Month 12)

  4. BPAR at 12 months

    Time frame: Assessed from date of transplant through Day 364 (Month 12)

    The proportion of BPAR at 12 months

Sponsors and collaborators

Lead sponsor

Eledon Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2023
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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