ReclutandoNCT07696962Registro de ClinicalTrials.gov

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

End Stage Renal Disease

Pregúntale a WCR sobre este estudio Registro oficial ↗

LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: De intervención
Fase: Fase 1
Rango de edad: 18 años - 70 años
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 4 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria

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

Exclusion Criteria:

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

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: No aplica
Enmascaramiento: Sin enmascaramiento

Porcine Thymokidney

Porcine Thymokidney transplanted into patients with End Stage Renal Disease

Biological: ChoironeX GalKO Porcine Thymokidney

ChoironeX GalKO Porcine Thymokidney BIOLOGICAL

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.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) from Day 0 through Month 6.

Plazo: 6 months