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NCT Number: NCT05027906

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

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

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Key information

Conditions

Prevention of Rejection in Kidney Transplant 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 1 / Phase 2

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

About this study

This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation. Up to 48 de novo kidney transplant recipients will receive AT-1501 in combination with rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy.

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, 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 criteria:
  • 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 (1.5 mg/dL)
  • 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:
  • 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

Investigative Arm

Primary outcomes

  1. Safety Incidences

    Time frame: Through study completion, an average up to 20 months

    Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and Adverse Events of Special Interest (AESIs)

  2. Pharmacokinetic- PK profile

    Time frame: Day 1 and at steady state Month 3

    PK 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)

  3. Pharmacokinetic- Area under the plasma concentration

    Time frame: Day 1 and at steady state Month 3

    Area under the plasma concentration versus time curve from time 0 extrapolated to infinity, calculated using noncompartmental analysis (AUC0-inf)

  4. Pharmacokinetic- Cmax

    Time frame: Day 1 and at steady state Month 3

    Maximum observed plasma concentration (Cmax)

  5. Pharmacokinetic- Tmax

    Time frame: Day 1 and at steady state Month 3

    Time to reach maximum observed plasma concentration (Tmax)

  6. Pharmacokinetic- Ke

    Time frame: Day 1 and at steady state Month 3

    Terminal elimination rate constant (Ke)

  7. Pharmacokinetic- (t1/2)

    Time frame: Day 1 and at steady state Month 3

    Terminal phase half-life (t1/2)

  8. Pharmacokinetic- CL

    Time frame: Day 1 and at steady state Month 3

    Clearance (CL)

  9. Pharmacokinetic- (Vdss)

    Time frame: Day 1 and at steady state Month 3

    Volume of distribution at steady state (Vdss)

Study contacts

Contact information is provided by the study sponsor or research team.

Eledon Pharmaceuticals

CONTACT

[email protected]

949-238-8090

Sponsors and collaborators

Lead sponsor

Eledon Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1b, Multicenter, Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 30, 2021
Registry last updated
Jun 29, 2025

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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