Clinical Trials in Australia / NCT05027906
Recruiting
Phase 1/2
Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
NCT05027906 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Prevention of Rejection in Kidney Transplant
Study summary
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
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 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
Primary outcome measure(s)
- 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- 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- Cmax — Day 1 and at steady state Month 3
Maximum observed plasma concentration (Cmax) - 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- (t1/2) — Day 1 and at steady state Month 3
Terminal phase half-life (t1/2) - Pharmacokinetic- CL — Day 1 and at steady state Month 3
Clearance (CL) - Pharmacokinetic- (Vdss) — Day 1 and at steady state Month 3
Volume of distribution at steady state (Vdss)
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | Recruiting |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | Recruiting |
| Royal Adelaide Hospital | Adelaide | South Australia | Recruiting |
| Fundação Oswaldo Ramos - Hospital do Rim | São Paulo | Brazil | Recruiting |
| Providence Health Care - St. Paul's Hospital | Vancouver | British Columbia | Recruiting |
| Vancouver General Hospital | Vancouver | British Columbia | Recruiting |
| McGill University Health Care Centre | Montreal | Quebec | Recruiting |
| Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital | Liverpool | United Kingdom | Recruiting |
| Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital | Oxford | United Kingdom | Recruiting |
More Eledon Pharmaceuticals trials in Australia
Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
Enrolling by invitation
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05027906 on ClinicalTrials.gov ↗ ← All trials in Australia