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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат AT-1501
  Investigative Arm

Первичные конечные точки

• Safety Incidences [Срок оценки: Through study completion, an average up to 20 months]
• Pharmacokinetic- PK profile [Срок оценки: Day 1 and at steady state Month 3]
• Pharmacokinetic- Area under the plasma concentration [Срок оценки: Day 1 and at steady state Month 3]
• Pharmacokinetic- Cmax [Срок оценки: Day 1 and at steady state Month 3]
• Pharmacokinetic- Tmax [Срок оценки: Day 1 and at steady state Month 3]
• Pharmacokinetic- Ke [Срок оценки: Day 1 and at steady state Month 3]
• Pharmacokinetic- (t1/2) [Срок оценки: Day 1 and at steady state Month 3]
• Pharmacokinetic- CL [Срок оценки: Day 1 and at steady state Month 3]
• Pharmacokinetic- (Vdss) [Срок оценки: Day 1 and at steady state Month 3]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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:

• 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)
• 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
• History of a TE event, known hypercoagulable state, or condition requiring long term anticoagulation:
• Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 3 центра

• Providence Health Care - St. Paul's Hospital — Vancouver
• Vancouver General Hospital — Vancouver
• McGill University Health Care Centre — Montreal

Австралия · 2 центра

• Royal Prince Alfred Hospital — Camperdown
• Royal Adelaide Hospital — Adelaide

Великобритания · 2 центра

• Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital — Liverpool
• Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital — Oxford

США · 1 центр

• University of Cincinnati — Cincinnati

Бразилия · 1 центр

• Fundação Oswaldo Ramos - Hospital do Rim — São Paulo

Идентификаторы

NCT: NCT05027906 · AT-1501-K102 · 2021-003830-36

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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