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

Kidney Transplant Clinical Trial

Official title:

A Phase 1b, Multicenter, Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05027906
• Other study ID #: AT-1501-K102
• Secondary ID: 2021-003830-36
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 18, 2022
• Est. completion date: September 2025

Study information

• Verified date: December 2023
• Source: Eledon Pharmaceuticals
• Contact: Eledon Pharmaceuticals
• Phone: 949-238-8090
• Email: clinicaltrials[@]eledon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Drug:
• AT-1501
Investigative Arm

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Canada	McGill University Health Care Centre	Montréal	Quebec
Canada	Providence Health Care - St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
United Kingdom	Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Eledon Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Pharmacokinetic- Cmax	Maximum observed plasma concentration (Cmax)	Day 1 and at steady state Month 3
Primary	Pharmacokinetic- Tmax	Time to reach maximum observed plasma concentration (Tmax)	Day 1 and at steady state Month 3
Primary	Pharmacokinetic- Ke	Terminal elimination rate constant (Ke)	Day 1 and at steady state Month 3
Primary	Pharmacokinetic- (t1/2)	Terminal phase half-life (t1/2)	Day 1 and at steady state Month 3
Primary	Pharmacokinetic- CL	Clearance (CL)	Day 1 and at steady state Month 3
Primary	Pharmacokinetic- (Vdss)	Volume of distribution at steady state (Vdss)	Day 1 and at steady state Month 3