Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease

Официальное название

Phase 1 Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease

Обзор

The goal of this clinical trial is to learn if a GalKO Porcine Thymokidney can maintain renal function, without the need for dialysis, after transplantation into adult subjects with End Stage Renal Disease.

Вмешательства

• Биопрепарат ChoironeX GalKO Porcine Thymokidney
  A constructed thymokidney from a genetically modified porcine donor will be preserved, packaged, transported and transplanted into the study subject at the study site in the same fashion as a human donor kidney. The thymokidney will remain in the subject throughout the subject's lifetime, or until thymokidney explant.

Первичные конечные точки

• Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) from Day 0 through Month 6. [Срок оценки: 6 months]
• Overall survival of the recipient without the need for chronic dialysis at Month 6. [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Overall survival without the need for dialysis at Month 3. [Срок оценки: 3 months]
• Graft survival free from hyperacute rejection at Day 3. [Срок оценки: 3 Days]
• Incidence of acute and chronic xenograft rejection at Day 14, Months 3 and 6. [Срок оценки: 6 months]
• Banff classification of xenograft pathology at biopsy. [Срок оценки: 6 months]
• Renal filtration function as assessed by creatinine clearance (CrCl) by nuclear medicine scan at Day 14, Months 1, 3, and 6. [Срок оценки: 6 months]
• Total number of clinically significant fluid electrolyte, hemodynamic, acid-base, and hematologic abnormalities requiring medical intervention per patient through Month 6. [Срок оценки: 6 months]
• Total number of clinically significant mineral metabolism abnormalities requiring medical intervention per patient through Month 6 [Срок оценки: 6 months]
• Incidences of severe proteinuria (i.e., urinary protein: creatinine ratio of >3.5 g/g) per patient through Month 6. [Срок оценки: 6 months]
• Change from baseline in blood pressure at Months 3 and 6. [Срок оценки: 6 months]
• Incidence of porcine-derived infectious complications through Month 6, in study subjects, site staff, or close personal contacts. [Срок оценки: 6 months]
• Incidence of opportunistic infections (excluding zoonoses) through Month 6, in study subjects. [Срок оценки: 6 months]
• Change from baseline in thymokidney size using ultrasound imaging at Day 14, 21, and Months 1-6. [Срок оценки: 6 months]

Критерии участия

Критерии включения

• ESRD receiving hemodialysis or peritoneal dialysis for ≥6 months
• Eligible for kidney transplantation per site criteria
• <50% likelihood of receiving a standard deceased-donor kidney transplant within 12 months
• Blood type and immunologic compatibility with study transplant confirmed by testing
• EBV seropositive
• Up to date on recommended vaccinations for immunocompromised individuals
• Willing to use protocol-required contraception
• Able to provide informed consent and comply with lifelong follow-up

Критерии исключения

• Requirement for multi-organ transplantation
• Living donor available who is ABO-incompatible
• Kidney disease with high risk of post-transplant recurrence
• Polycystic kidney disease without prior native nephrectomy
• Unable or unwilling to comply with study procedures
• History of non-adherence to medical treatment
• Identified as vulnerable by psychological assessment
• Significant uncontrolled psychiatric illness
• Inadequate social support or caregiver unavailable/unwilling
• Current drug or alcohol misuse
• Serious non-renal illness with life expectancy <1 year
• BMI <16 or >35 kg/m²
• Known hypercoagulable disorder
• Uncontrolled hypertension or hemodynamic instability at enrollment
• Clinically significant cardiovascular disease, including poorly controlled coronary artery disease, reduced left ventricular function, recent myocardial infarction or cardiac intervention, or clinically significant arrhythmia requiring treatment
• Serious liver disease or impaired liver function
• Diabetes mellitus with poor glycemic control (HbA1c >10%)
• Active infection at time of transplantation
• Positive serology for hepatitis B, hepatitis C, or HIV
• Current, active, or untreated tuberculosis
• Malignancy within 5 years prior to enrollment, excluding adequately treated non-melanoma skin cancer
• Current systemic immunosuppressive therapy (excluding permitted corticosteroids)
• Participation in another interventional drug trial within 60 days prior to enrollment
• Pregnant or breastfeeding
• Known severe hypersensitivity to a required study medication with no acceptable alternative

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

США · 2 центра

• Study Site 2 — New York
• Study Site 1 — New York

Идентификаторы

NCT: NCT07696962 · CHX-01-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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