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 range18 Years – 100 Years

SexALL

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
✕. Medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day

What they're measuring

Safety Incidences

Timeframe: Through study completion, an average up to 20 months

Pharmacokinetic- PK profile

Timeframe: Day 1 and at steady state Month 3

Pharmacokinetic- Area under the plasma concentration

Timeframe: Day 1 and at steady state Month 3

Pharmacokinetic- Cmax

Timeframe: Day 1 and at steady state Month 3

Pharmacokinetic- Tmax

Timeframe: Day 1 and at steady state Month 3

Pharmacokinetic- Ke

Timeframe: Day 1 and at steady state Month 3

Pharmacokinetic- (t1/2)

Timeframe: Day 1 and at steady state Month 3

Pharmacokinetic- CL

Timeframe: Day 1 and at steady state Month 3

Trial details

NCT IDNCT05027906

SponsorEledon Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Eledon Pharmaceuticals

949-238-8090 clinicaltrials@eledon.com

View on ClinicalTrials.gov More Prevention of Rejection in Kidney Transplant trials

Who can participate

Age range18 Years – 100 Years

SexALL

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
✕. Medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day

What they're measuring

Safety Incidences

Timeframe: Through study completion, an average up to 20 months

Pharmacokinetic- PK profile

Timeframe: Day 1 and at steady state Month 3

Pharmacokinetic- Area under the plasma concentration

Timeframe: Day 1 and at steady state Month 3

Pharmacokinetic- Cmax

Timeframe: Day 1 and at steady state Month 3

Pharmacokinetic- Tmax

Timeframe: Day 1 and at steady state Month 3

Pharmacokinetic- Ke

Timeframe: Day 1 and at steady state Month 3

Pharmacokinetic- (t1/2)

Timeframe: Day 1 and at steady state Month 3

Pharmacokinetic- CL

Timeframe: Day 1 and at steady state Month 3