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 details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- History of a TE event, known hypercoagulable state, or condition requiring long term anticoagulation:
- Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1PHASE2
Study ID
NCT05027906
Intervention or treatment
DRUG: AT-1501
Conditions
- Prevention of Rejection in Kidney Transplant
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Research sites nearby
Closest Location:
Royal Prince Alfred Hospital
Select from list below to view details:
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
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Who is running the clinical trial?
Eledon Pharmaceuticals
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: AT-1501 Single Arm
| Drug: AT-1501 |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Secondary Outcome
References
Clinical Trials Gov: Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney TransplantOther trials to consider
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