At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AT-1501 (drug)
- How long the study runs
- Study runs about 59 months (dates as stated)
- About the drug or intervention
- AT-1501 — drug: Investigative Arm
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at the safety, how the drug moves through the body, and whether AT 1501 works in adults having their first kidney transplant. It aims to help prevent rejection of the new kidney. It is run by Eledon Pharmaceuticals.
Who can take part
- Adults aged 18 or over, male or female
- People having their first kidney transplant, from either a living or deceased donor
- Agreeing to use contraception during the study and for at least 90 days after the last dose of the study drug
Who may not be able to
- Planning induction therapy other than the study-assigned rATG (rabbit anti-thymocyte globulin, a drug that dampens the immune system)
- Currently taking drugs that suppress the immune system, except up to 5 mg of prednisone (a steroid) or equivalent daily
- Previous treatment with AT 1501 or any other anti-CD40LG therapy
- Previous bone marrow transplant or any solid organ transplant, including a kidney, or having a multi-organ or dual kidney transplant
- Receiving a kidney expected to have a cold storage (ischaemia) time over 30 hours
- Receiving a kidney from a donor who died after their heart stopped (donation after cardiac death), or who meets 'extended criteria' (for example, aged 60 or over, or aged 50-59 with two of: death from a stroke, history of high blood pressure, or high creatinine levels), or whose blood group does not match yours
- Having a donor who is an exact tissue (human leukocyte antigen, HLA) match
- Medical conditions needing long-term steroid doses above 5 mg prednisone or equivalent per day
- Past blood clot (thromboembolic event), a known clotting tendency, or needing long-term blood-thinning medicine
- A positive T- or B-cell crossmatch caused by HLA antibodies, or having donor-specific antibodies at screening
What taking part involves
- • Taking the study drug AT 1501 — details of how it is given and how often are not stated — ask the trial team
- • Receiving rATG (rabbit anti-thymocyte globulin) as part of the study treatment
- • Any other parts of the treatment are not stated — ask the trial team
Time commitment: Not stated — ask the trial team about study visits, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 100 Years
- Who
- All
- Number of participants
- 48
- Started
- 2022-02-18
- Last checked
- 2025-06
Plain English Summary
What is this study?
- • Testing a new treatment for prevention of rejection in kidney transplant
- • Phase1/Phase2 - 48 participants
- • This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation
Who can take part?
- • Ages 18 Years to 100 Years
- • Diagnosed with prevention of rejection in kidney transplant
Where?
- • Liverpool - Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital
- • Oxford - Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 100 Years
- Who can join: All genders
What the study is looking for
- ✓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...
Who cannot take part
- ✗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...
- ✗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...
- ✗Will receive a kidney with an anticipated cold ischemia time of \> 30 hours;
See the full criteria
Where Is This Study? (2 UK sites)
Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital
Liverpool L78XP, United Kingdom
Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital
Oxford OX3 9DU, United Kingdom
How to Get in Touch
Eledon Pharmaceuticals
Sponsor contactCONTACT