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

Phase 1

Recruiting

• Conditions: Kidney Transplant
• Interventions: Drug: AT-1501

• Registration Number: NCT05027906
• Lead Sponsor: Eledon Pharmaceuticals

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-08-30
• Study Start: 2022-02-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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:

   • 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

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:

   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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AT-1501 Single Arm	AT-1501	AT-1501 monoclonal antibody targeting CD40L given as an IV infusion

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic- CL	Day 1 and at steady state Month 3	Clearance (CL)
Safety Incidences	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)
Pharmacokinetic- PK profile	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)
Pharmacokinetic- Tmax	Day 1 and at steady state Month 3	Time to reach maximum observed plasma concentration (Tmax)
Pharmacokinetic- Ke	Day 1 and at steady state Month 3	Terminal elimination rate constant (Ke)
Pharmacokinetic- Cmax	Day 1 and at steady state Month 3	Maximum observed plasma concentration (Cmax)
Pharmacokinetic- Area under the plasma concentration	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)
Pharmacokinetic- (t1/2)	Day 1 and at steady state Month 3	Terminal phase half-life (t1/2)
Pharmacokinetic- (Vdss)	Day 1 and at steady state Month 3	Volume of distribution at steady state (Vdss)

Trial Locations

Locations (9)

Fundação Oswaldo Ramos - Hospital do Rim; 🇧🇷 São Paulo, Brazil

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Providence Health Care - St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

McGill University Health Care Centre; 🇨🇦 Montréal, Quebec, Canada

Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital; 🇬🇧 Liverpool, United Kingdom

Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital; 🇬🇧 Oxford, United Kingdom