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

NCT05027906 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: AT-1501-K1022021-003830-36
• Study Type: interventional
• Target: 48
• Locations: 5 countries
• Sites: 9

Brief Summary

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

Conditions

Prevention of Rejection in Kidney Transplant

Keywords

Kidney Transplant; Renal Allograft Rejection; Prophylaxis; AT-1501; CD40L inhibitor; Humanized blocking antibody to CD40L; Monoclonal Antibody; Renal; Transplant; ESRD; tegoprubart

Outcome Measures

Primary Outcomes (9)

• Safety Incidences

  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

  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

  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

• Pharmacokinetic- Cmax

  Maximum observed plasma concentration (Cmax)

  Day 1 and at steady state Month 3

• Pharmacokinetic- Tmax

  Time to reach maximum observed plasma concentration (Tmax)

  Day 1 and at steady state Month 3

• Pharmacokinetic- Ke

  Terminal 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- CL

  Clearance (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

Study Arms (1)

AT-1501 Single Arm

EXPERIMENTAL

AT-1501 monoclonal antibody targeting CD40L given as an IV infusion

Drug: AT-1501

Interventions

AT-1501 DRUG

Investigative Arm

AT-1501 Single Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eledon Pharmaceuticals: lead

Study Sites (9)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, SA 5000, Australia

RECRUITING

Fundação Oswaldo Ramos - Hospital do Rim

São Paulo, Brazil

RECRUITING

Providence Health Care - St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

McGill University Health Care Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital

Liverpool, L78XP, United Kingdom

RECRUITING

Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eledon Pharmaceuticals

CONTACT

949-238-8090; clinicaltrials@eledon.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: None ( Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1b, open label, single-arm study

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 30, 2021
• Study Start: February 18, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); US (1); BR (1); AU (2); GB (2)