Recruiting NCT05027906
Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AT-1501.
- Who it may be relevant to
- Registry conditions: Prevention of Rejection in Kidney Transplant. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Brazil, Canada, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1b, Multicenter, Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
Overview
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 48 de novo kidney transplant recipients will receive AT-1501 in combination with rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy.
Interventions
- Drug AT-1501
Investigative Arm
Primary outcome measures
- Safety Incidences [Time frame: Through study completion, an average up to 20 months]
- Pharmacokinetic- PK profile [Time frame: Day 1 and at steady state Month 3]
- Pharmacokinetic- Area under the plasma concentration [Time frame: Day 1 and at steady state Month 3]
- Pharmacokinetic- Cmax [Time frame: Day 1 and at steady state Month 3]
- Pharmacokinetic- Tmax [Time frame: Day 1 and at steady state Month 3]
- Pharmacokinetic- Ke [Time frame: Day 1 and at steady state Month 3]
- Pharmacokinetic- (t1/2) [Time frame: Day 1 and at steady state Month 3]
- Pharmacokinetic- CL [Time frame: Day 1 and at steady state Month 3]
- Pharmacokinetic- (Vdss) [Time frame: Day 1 and at steady state Month 3]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 3 centers
- Providence Health Care - St. Paul's Hospital — Vancouver
- Vancouver General Hospital — Vancouver
- McGill University Health Care Centre — Montreal
Australia · 2 centers
- Royal Prince Alfred Hospital — Camperdown
- Royal Adelaide Hospital — Adelaide
United Kingdom · 2 centers
- Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital — Liverpool
- Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital — Oxford
United States · 1 center
- University of Cincinnati — Cincinnati
Brazil · 1 center
- Fundação Oswaldo Ramos - Hospital do Rim — São Paulo
Identifiers
NCT: NCT05027906 · AT-1501-K102 · 2021-003830-36