Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
NCT ID: NCT05027906
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
48 participants
INTERVENTIONAL
2022-02-18
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AT-1501 Single Arm
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
AT-1501
Investigative Arm
Interventions
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AT-1501
Investigative Arm
Eligibility Criteria
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Inclusion Criteria
2. Recipient of their first kidney transplant from a living or deceased donor
3. Agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug
Exclusion Criteria
2. Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies, with the exception of 5 mg prednisone or equivalent daily;
3. Previous treatment with AT 1501 or any other anti CD40LG therapy
4. 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
5. Will receive a kidney with an anticipated cold ischemia time of \> 30 hours;
6. 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)
7. Human leukocyte antigen identical (two haplotype match or zero HLA mismatch) donor
8. Medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day
9. History of a TE event, known hypercoagulable state, or condition requiring long term anticoagulation:
10. Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening
18 Years
100 Years
ALL
No
Sponsors
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Eledon Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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University of Cincinnati
Cincinnati, Ohio, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Fundação Oswaldo Ramos - Hospital do Rim
São Paulo, , Brazil
Providence Health Care - St. Paul's Hospital
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
McGill University Health Care Centre
Montreal, Quebec, Canada
Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital
Liverpool, , United Kingdom
Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Research Staff
Role: primary
Research Staff
Role: primary
Research Staff
Role: primary
Research Staff
Role: primary
Research Staff
Role: primary
Research Staff
Role: primary
Research Staff
Role: primary
Research Staff
Role: primary
Research Staff
Role: primary
Other Identifiers
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2021-003830-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AT-1501-K102
Identifier Type: -
Identifier Source: org_study_id
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