Autologous Tolerogenic Dendritic Cells (ATDC) for Highly Sensitized Kidney Transplant Recipients

Обзор

The ATDC-PICI study is a Phase Ib, single-arm, prospective, non-randomized, multicentric trial, to evaluate the safety of ATDC cell product as adjunctive therapy to standard of care (SOC) in highly sensitized kidney transplant recipients.

Подробное описание

The study population is sensitized kidney transplant candidates (cPRA ≥ 90%) between 18 and 65 years.

An algorithm has been designed to rank highly sensitized patients on the waiting list for kidney transplantation according to their likelihood of obtaining a suitable donor within the upcoming 12 months. The algorithm was designed based on an analysis of an immunologically matched historical cohort using data from the OCATT registry.

Patients will be selected in accordance with the algorithm and proposed for inclusion in the study in a sequential manner until the required number of patients has been reached (n=30). Given the unpredictability and reduced likelihood of obtaining a compatible deceased kidney donor within an acceptable time frame for this study, the total number of patients to be included will be 2x superior to those who will receive treatment with ATDC (n=15).

* 30 highly sensitized patients will be pre-included in the study. * The first 15 highly sensitized patients that obtain a compatible deceased kidney donor will be included in the study.

Вмешательства

• Биопрепарат Autologous Tolerogenic Dendritic Cells
  • Autologous Tolerogenic Dendritic Cells (D+1 to D+3 post-transplantation), ATDC, 1 million ATDC/Kg over a period of 30 minutes (up to 1 hour) will administer between Day 1 and Day 3 after transplantation.

Первичные конечные точки

• Side effects of ATDC cell product in highly sensitized patients who received a kidney from a deceased donor. [Срок оценки: at day 1 and day 3]

Вторичные конечные точки (7)

• Rate of infectious disease that required hospitalization at 6 and 12 months. [Срок оценки: at 6 months and 12 months.]
• To evaluate incidence of biopsy proven acute rejection episodes in patients treated with ATDC as adjunctive therapy to SOC [Срок оценки: at 3 and 12months after transplantation.]
• To evaluate renal function up to 1 year after transplantation [Срок оценки: at 3, 6 and 12 months after transplantation]
• To evaluate renal function up to 1 year after transplantation [Срок оценки: at 3, 6 and 12 months after transplantation]
• To evaluate patient survival [Срок оценки: at 12 months after transplantation]
• To evaluate graft survival [Срок оценки: at 12 months after transplantation]
• To characterize the immunophenotype status. [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Highly sensitized (cPRA ≥ 90%) kidney transplant candidates between 18 and 65 years old.
• To be selected by the algorithm according to probability of kidney transplantation in the upcoming 12months.
• Adequate venous access and absence of contraindications for leukoapheresis.
• Women of childbearing age must take contraceptive measures.
• Must have given written informed consent

Критерии исключения

• Subjects with active TB.
• Patients on the waiting list multiple organ transplants.
• A significantly abnormal general serum screening lab result defined as WBC<3.0x103/ml, Hgb<8.0 g/dL, platelet count <100x103/ml, SGOT>3x upper limit.
• HIV-positive subjects.
• Subjects who test positive for HBV infection \[positive HBVsAg or HBVeAg/DNA\] or HCV infection \[RNA+\].
• Subjects with active CMV or EBV infection as defined by positive PCR.
• Subjects with a known history of previous myocardial infarction within one year of screening.
• Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.
• Patients with a kidney disease with high risk of recurrence and/or complement-associated kidney disease (aHUS, etc).
• Pregnant and lactating women.

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

Другое

Центры проведения

Испания · 7 центров

• Hospital Germans Trias i Pujol — Badalona
• Hospital del Mar — Barcelona
• Fundació Puigvert — Barcelona
• Hospital Vall d'Hebron — Barcelona
• Hospital Clinic Barcelona — Barcelona
• Hospital Universitari Bellvitge — L'Hospitalet de Llobregat
• Hospital Universitario Miguel Servet — Zaragoza

Идентификаторы

NCT: NCT06852625 · 2024-519978-39-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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