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

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: Recruiting
• Conditions: Prevention of Rejection in Kidney Transplant
• Intervention / Treatment: Drug: AT-1501

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: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Eledon Pharmaceuticals; Phone Number: 949-238-8090; Email: clinicaltrials@eledon.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of BPAR	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	Changes in eGFR	Month 1 to Month 3, 6, 12, and 15 post-transplant
Rate of composite endpoint	Rate of composite endpoint (graft failure, BPAR, or death)	12 months post-transplant
Incidence of DSA	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)	(dd-cfDNA)	3, 6, 9, and 12 months post-transplant and at the time of for cause biopsies
Pharmacodynamic Studies	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	Trough levels	Days 7, 14, 21 and Months 1, 3, 6, 9, and 12 post-transplant
Anti-AT-1501 antibody studies	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

• Sponsor: Eledon Pharmaceuticals
• Investigators: Study Chair: Jeff Bornstein, MD, Eledon Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: ESRD; Transplant; Monoclonal Antibody; Prophylaxis; Kidney Transplant; Renal; AT-1501; Renal Allograft Rejection; CD40L inhibitor; Humanized blocking antibody to CD40L; tegoprubart
• Other Study ID 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