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Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

PHASE2RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-08-30

    Primary completion: 2025-03-01

    Study completion finish: 2025-03-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

    trial

    Trial ID

    NCT05983770

    Intervention or treatment

    DRUG: AT-1501

    DRUG: Tacrolimus

    Conditions

    • Kidney Transplant Rejection

    Find a site

    Closest Location:

    Royal Adelaide Hospital

    Research sites nearby

    Select from list below to view details:

    • Royal Adelaide Hospital

      Adelaide, South Australia, Australia

    • Fiona Stanley Hospital

      Perth, Western Australia, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/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.
    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.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    eGFR at 12 monthsEstimated Glomerular Filtration Rate (eGFR) at 12 months post-transplantAssessed from date of transplant through Day 364 (Month 12)

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    NODAT at 12 months post-transplantThe proportion of new onset diabetes after transplant (NODAT) at 12 months post-transplantAssessed from date of transplant through Day 364 (Month 12
    The proportion of patient and graft survival at 12 months post-transplantPatient and graft survival are defined as either A) Death, B) re-transplantation or C) Requirement for regular dialysisAssessed from date of transplant through Day 364 (Month 12)
    BPAR-free patient and graft survival at 12 months post-transplantAssessed from date of transplant through Day 364 (Month 12)The proportion of BPAR-free patient and graft survival at 12 months post-transplant
    BPAR at 12 monthsThe proportion of BPAR at 12 monthsAssessed from date of transplant through Day 364 (Month 12)

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

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