- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00001859
Screening for Patients Needing Kidney, Kidney-Pancreas, or Islet-Cell Transplant
Screening Protocol for Patients Needing a Kidney, Kidney-Pancreas, or Islet Cell Transplant
Kidney transplantation is the preferred treatment for most end-stage kidney disease. This procedure is limited, however, by two major factors: 1) a shortage of donor organs and 2) organ rejection by the recipient. The National Institute of Diabetes and Digestive and Kidney Diseases is screening patients with kidney failure or diabetes who may be eligible for kidney, kidney and pancreas, or islet cell transplantation.
Patients in this screening study are not offered treatment. When the screening is complete, patients will be offered an opportunity to participate in another institute study, or, if there are no active studies appropriate for the patient, other options will be suggested to the primary or referring physician. Patients found eligible for a study are not obligated to participate.
Screening for all patients typically consists of blood tests, urinalysis, electrocardiogram, PPD tuberculosis screen and pregnancy test. Chest and kidney X-rays and other studies may be done on patients determined eligible for a particular study, including transplantation. A summary of all test results will be sent to the referring physician unless the patient requests otherwise.
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Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
- INCLUSION CRITERIA:
Patients will be entered on this protocol at the time of their first visit to the NIH Clinical Center Outpatient Clinic or Inpatient Services if:
The patient carries the diagnosis of a disorder for which the Transplant Branch has active research interest, and based on information received from an outside physician, they meet preliminary eligibility criteria for other specific research protocols.
The patient or the patient's guardian is capable of providing informed consent, and signs the informed consent after initial counseling by clinical staff. Separate consent forms for all interventional procedures will be obtained after explanation of the specific procedure.
EXCLUSION CRITERIA:
History of known malignancies except basal cell carcinoma of the skin.
Inability to give legal informed consent by self or legal guardian.
Inability or willingness to comply with protocol monitoring and therapy, including, among others, a history of noncompliance, circumstances where compliance with protocol requirements is not feasible due to living conditions, travel restrictions, access to urgent medical services, or access to anti-rejection drugs after the research protocol is completed.
Plan de estudios
¿Cómo está diseñado el estudio?
Colaboradores e Investigadores
Investigadores
- Investigador principal: Monique E Cho, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 990120
- 99-DK-0120
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