Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorEledon Pharmaceuticals
About this trial
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
AT-1501
DrugInvestigative Arm
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: AT-1501 Single ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety Incidences
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and Adverse Events of Special Interest (AESIs)
Time frame
Through study completion, an average up to 20 months2
Pharmacokinetic- PK profile
PK profile of the first dose of AT 1501 and at steady state Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (Ct), calculated using noncompartmental analysis (AUC0-t)
Time frame
Day 1 and at steady state Month 33
Pharmacokinetic- Area under the plasma concentration
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity, calculated using noncompartmental analysis (AUC0-inf)
Time frame
Day 1 and at steady state Month 34
Pharmacokinetic- Cmax
Maximum observed plasma concentration (Cmax)
Time frame
Day 1 and at steady state Month 3Sponsors and contacts
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Source ClinicalTrials.gov