Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant (NCT05027906) | Clinical Trial Compass
RecruitingPhase 1/2
Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
United States, Australia, Brazil48 participantsStarted 2022-02-18
Plain-language summary
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
. Human leukocyte antigen identical (two haplotype match or zero HLA mismatch) donor
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety Incidences
Timeframe: Through study completion, an average up to 20 months
2
Pharmacokinetic- PK profile
Timeframe: Day 1 and at steady state Month 3
3
Pharmacokinetic- Area under the plasma concentration