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AT-1501 for Kidney Transplant Rejection Prevention

This study is looking at a new drug called AT-1501 to see if it's safe and effective in preventing kidney rejection after a transplant. It will also check how the body processes the drug (pharmacokinetics or PK). Up to 48 people who are getting their first kidney transplant, aged 18 to 100, can join. You would receive AT-1501 along with other standard medications. The researchers will track any side effects and how well AT-1501 works to prevent rejection. The study status is currently unclear, so it's not known if they are actively enrolling.

Study design
This is an interventional study involving up to 48 participants. It will evaluate the safety, pharmacokinetics, and efficacy of AT-1501.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety up to an average of 20 months after the study starts.

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NCT05027906

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Eledon Pharmaceuticals
~48 participants
Updated 2025-06-29 on ClinicalTrials.gov
What's tested:AT-1501

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety Incidences
Measured over Through study completion, an average up to 20 months
+8 more outcomes measured

Conditions

Prevention of Rejection in Kidney Transplant

Explore related trials

Kidney Transplantation

Where it's being run

9 sites across 7 states
British Columbia2
United Kingdom2
Ohio1
New South Wales1
South Australia1
Brazil1
Quebec1

Who to contact

Eledon Pharmaceuticals
[email protected]
949-238-8090
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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) 7. Human leukocyte antigen identical (two haplotype match or zero HLA mismatch) donor 8. Medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day 9. History of a TE event, known hypercoagulable state, or condition requiring long term anticoagulation: 10. Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening

What this trial measures

  • Safety IncidencesThrough 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)

  • Pharmacokinetic- PK profileDay 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)

  • Pharmacokinetic- Area under the plasma concentrationDay 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)

  • Pharmacokinetic- CmaxDay 1 and at steady state Month 3

    Maximum observed plasma concentration (Cmax)

  • Pharmacokinetic- TmaxDay 1 and at steady state Month 3

    Time to reach maximum observed plasma concentration (Tmax)

  • Pharmacokinetic- KeDay 1 and at steady state Month 3

    Terminal elimination rate constant (Ke)

  • Pharmacokinetic- (t1/2)Day 1 and at steady state Month 3

    Terminal phase half-life (t1/2)

  • Pharmacokinetic- CLDay 1 and at steady state Month 3

    Clearance (CL)

  • Pharmacokinetic- (Vdss)Day 1 and at steady state Month 3

    Volume of distribution at steady state (Vdss)