RECRUITING

Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant

Conditions

Kidney Transplant Renal Allograft Rejection Prophylaxis AT-1501 CD40L inhibitor Humanized blocking antibody to CD40L Monoclonal Antibody Renal Transplant ESRD tegoprubart

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.

Official Title

A Phase 1b, Multicenter, Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant

Quick Facts

Study Start:2022-02-18

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05027906

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female ≥ 18 years of age 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	1. Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen 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: * 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 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: 1. Patients with a history of clotted venous access not requiring long term anticoagulation may be included at the Investigator's discretion if have no other history of TE events or known hypercoagulable state

Inclusion Criteria

Exclusion Criteria

1. Male or female ≥ 18 years of age
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

1. Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen
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:
* 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
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:
1. Patients with a history of clotted venous access not requiring long term anticoagulation may be included at the Investigator's discretion if have no other history of TE events or known hypercoagulable state

Contacts and Locations

Study Contact

Eledon Pharmaceuticals

CONTACT

949-238-8090

clinicaltrials@eledon.com

Study Locations (Sites)

University of Cincinnati

Cincinnati, Ohio, 45267

United States

Collaborators and Investigators

Sponsor: Eledon Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-18

Study Completion Date2025-09

Study Record Updates

Study Start Date2022-02-18

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

Kidney Transplant
Renal Allograft Rejection
Prophylaxis
AT-1501
CD40L inhibitor
Humanized blocking antibody to CD40L
Monoclonal Antibody
Renal
Transplant
ESRD
tegoprubart

Additional Relevant MeSH Terms

Kidney Transplant