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Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant

PHASE1PHASE2RECRUITING

This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.

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Study details:

This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation. Up to 24 de novo kidney transplant recipients will receive AT-1501 in combination with rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy.

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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, with the exception of 5 mg prednisone or equivalent daily;
  • Previous treatment with AT 1501 or any other anti CD40LG therapy
  • The patient has previously received a bone marrow transplant or any other solid organ transplant, including a kidney, or will be undergoing a multi organ or dual kidney transplant
  • 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: • Donation after Cardiac Death (DCD) criteria; or Extended Criteria Donor (ECD) criteria, defined as: * Is blood group (ABO) incompatible; or * Age ≥ 60 years; or * Age 50-59 years with any 2 of the following criteria * Death due to cerebrovascular accident * History of hypertension * Terminal creatinine ≥ 133 μmol/L
  • Human leukocyte antigen identical (two haplotype match or zero HLA mismatch) donor
  • Medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day
  • History of a TE event, known hypercoagulable state, or condition requiring long term anticoagulation: 1. Patients with a history of clotted venous access not requiring long term anticoagulation may be included at the Investigator's discretion if have no other history of TE events or known hypercoagulable state
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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: 2022-02-18

    Primary completion: 2025-09-01

    Study completion finish: 2025-09-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

      PHASE2

    trial

    Trial ID

    NCT05027906

    Intervention or treatment

    DRUG: AT-1501

    Conditions

    • Kidney Transplant

    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

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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: AT-1501 Single Arm
    • AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
    DRUG: AT-1501
    • Investigative Arm

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Safety IncidencesIncidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and Adverse Events of Special Interest (AESIs)Through study completion, an average up to 20 months
    Pharmacokinetic- PK profilePK profile of the first dose of AT 1501 and at steady state Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (Ct), calculated using noncompartmental analysis (AUC0-t)Day 1 and at steady state Month 3
    Pharmacokinetic- Area under the plasma concentrationArea under the plasma concentration versus time curve from time 0 extrapolated to infinity, calculated using noncompartmental analysis (AUC0-inf)Day 1 and at steady state Month 3
    Pharmacokinetic- CmaxMaximum observed plasma concentration (Cmax)Day 1 and at steady state Month 3
    Pharmacokinetic- TmaxTime to reach maximum observed plasma concentration (Tmax)Day 1 and at steady state Month 3
    Pharmacokinetic- KeTerminal elimination rate constant (Ke)Day 1 and at steady state Month 3
    Pharmacokinetic- (t1/2)Terminal phase half-life (t1/2)Day 1 and at steady state Month 3
    Pharmacokinetic- CLClearance (CL)Day 1 and at steady state Month 3
    Pharmacokinetic- (Vdss)Volume of distribution at steady state (Vdss)Day 1 and at steady state Month 3

    Secondary outcome

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant

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