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Tests treatment safety and results for Prevention of Rejection in Kidney Transplant
Official title Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
ClinicalTrials.gov ID: NCT05027906
What this study is testing
What is AT-1501?
AT-1501 is an investigational medicine, being studied as a potential treatment for prevention of rejection in kidney transplant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- 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:
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
- Camperdown, New South Wales, Australia
- Adelaide, South Australia, Australia
- São Paulo, Brazil
- Vancouver, British Columbia, Canada
- Montreal, Quebec, Canada
- Liverpool, United Kingdom
- Oxford, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States; Camperdown, New South Wales, Australia; Adelaide, South Australia, Australia; São Paulo, Brazil; Vancouver, British Columbia, Canada; Montreal, Quebec, Canada and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.