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

June 25, 2025 updated by: Eledon Pharmaceuticals

A Phase 1b, Multicenter, Open Label Study to Evaluate the 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Royal Prince Alfred Hospital
        • Contact:
          • Research Staff
    • South Australia
      • Adelaide, South Australia, Australia, SA 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
          • Research Staff
  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • Fundação Oswaldo Ramos - Hospital do Rim
        • Contact:
          • Research Staff
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Recruiting
        • Providence Health Care - St. Paul's Hospital
        • Contact:
          • Research Staff
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Recruiting
        • Vancouver General Hospital
        • Contact:
          • Research Staff
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Care Centre
        • Contact:
          • Research Staff
  • United Kingdom
      • Liverpool, United Kingdom, L78XP
        • Recruiting
        • Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital
        • Contact:
          • Research Staff
      • Oxford, United Kingdom, OX3 9DU
        • Recruiting
        • Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital
        • Contact:
          • Research Staff
  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati
        • Contact:
          • Research Staff

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female ≥ 18 years of age
  2. Recipient of their first kidney transplant from a living or deceased donor
  3. Agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug

Exclusion Criteria:

  1. Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen
  2. Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies, with the exception of 5 mg prednisone or equivalent daily;
  3. Previous treatment with AT 1501 or any other anti CD40LG therapy
  4. 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
  5. Will receive a kidney with an anticipated cold ischemia time of > 30 hours;

  6. 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)
  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

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic- Cmax
Time Frame: Day 1 and at steady state Month 3
Maximum observed plasma concentration (Cmax)
Day 1 and at steady state Month 3
Pharmacokinetic- Tmax
Time Frame: Day 1 and at steady state Month 3
Time to reach maximum observed plasma concentration (Tmax)
Day 1 and at steady state Month 3
Pharmacokinetic- Ke
Time Frame: Day 1 and at steady state Month 3
Terminal elimination rate constant (Ke)
Day 1 and at steady state Month 3
Pharmacokinetic- (t1/2)
Time Frame: Day 1 and at steady state Month 3
Terminal phase half-life (t1/2)
Day 1 and at steady state Month 3
Pharmacokinetic- CL
Time Frame: Day 1 and at steady state Month 3
Clearance (CL)
Day 1 and at steady state Month 3
Pharmacokinetic- (Vdss)
Time Frame: Day 1 and at steady state Month 3
Volume of distribution at steady state (Vdss)
Day 1 and at steady state Month 3
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)
Through study completion, an average up to 20 months
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)
Day 1 and at steady state Month 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)
Day 1 and at steady state Month 3

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of BPAR
Time Frame: 6 and 12 months post-transplant
Incidence of BPAR (T cell-mediated rejection [TCMR] Banff Grade ≥ 1A and antibody mediated rejection [AMR])
6 and 12 months post-transplant
Change in eGFR
Time Frame: Month 1 to Month 3, 6, 12, and 15 post-transplant
Changes in eGFR
Month 1 to Month 3, 6, 12, and 15 post-transplant
Rate of composite endpoint
Time Frame: 12 months post-transplant
Rate of composite endpoint (graft failure, BPAR, or death)
12 months post-transplant
Incidence of DSA
Time Frame: 1, 3, 6, 9, and 12 months post-transplant and at the time of for cause biopsies
DSA
1, 3, 6, 9, and 12 months post-transplant and at the time of for cause biopsies
Incidence of donor derived cell free DNA (dd-cfDNA)
Time Frame: 3, 6, 9, and 12 months post-transplant and at the time of for cause biopsies
(dd-cfDNA)
3, 6, 9, and 12 months post-transplant and at the time of for cause biopsies
Pharmacodynamic Studies
Time Frame: Day 0 and Months 3, 6, 9, and 12 post-transplant and at the time of for-cause biopsies
CD40L receptor occupancy and gene expression studies
Day 0 and Months 3, 6, 9, and 12 post-transplant and at the time of for-cause biopsies
Trough levels of AT-1501
Time Frame: Days 7, 14, 21 and Months 1, 3, 6, 9, and 12 post-transplant
Trough levels
Days 7, 14, 21 and Months 1, 3, 6, 9, and 12 post-transplant
Anti-AT-1501 antibody studies
Time Frame: Screening, Day 0, 7, 14, and Months 1, 3, 6, 9, 12, and 15 post-transplant
Incidence of anti- AT-1501 antibodies
Screening, Day 0, 7, 14, and Months 1, 3, 6, 9, 12, and 15 post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eledon Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jeff Bornstein, MD, Eledon Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AT-1501-K102
  • 2021-003830-36 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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