- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00001856
Live Donors for Kidney Transplants
Live Donor Renal Donation for Allotransplantation
On a yearly basis there are approximately 12,000 kidney transplants in the United States. Presently there are approximately 40,000 patients awaiting a transplant with only 5,000 available donors. Due to the obvious difference between organ supply and demand, live donors have become a standard source of kidneys for transplantation.
Research has proven that kidneys from living donors are superior to cadaveric donors (kidneys harvested from a deceased individual). Kidneys from living donors are not exposed to extremely low temperature that could increase post-operative problems. They are less likely to experience rejection and there is a decreased likelihood that a patient will have to undergo post-operative dialysis.
The objective of this study is to promote the enrollment of healthy individuals to serve as kidney donors for patients undergoing research kidney transplantation at the NIH. Potential donors will be screened to make sure they are able to survive with a single kidney without significant medical risk. Additional tests will be taken to establish compatibility with the recipient. Compatible donors will be evaluated to determine which kidney is suitable for transplantation. Both the donation and transplantation procedure will be conducted on the same day. Appropriate post-operative care and follow-up will be provided at the Clinical Center.
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
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
- INCLUSION CRITERIA:
Willingness to donate without evidence of secondary gain, coercion, or conflict of interest.
Age greater than or equal to 18 years
ABO compatible with recipient
Normal renal function with a 24hr creatinine clearance greater than 80ml/min/1.73m(2).
Willingness and legal ability to give informed consent
Recipient is enrolled in a NIH protocol for transplantation or has been established as a candidate for receipt of an altruistic or paired donation through the Washington Regional Organ Procurement Agency donor program.
EXCLUSION CRITERIA:
Hypertension
Pregnancy
History of stroke
Active tuberculosis
History of active malignancies except basal cell carcinoma of the skin.
Major anticipated illness or organ failure incompatible with survival after nephrectomy
Functionally significant coronary artery disease.
Active kidney stones
Proteinuria (greater than 250mg/24hr)
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
Publicaciones Generales
- Cicciarelli J. Living donor kidney transplants. Clin Transpl. 1988:293-9.
- Matas AJ, Gillingham KJ, Sutherland DE. Half-life and risk factors for kidney transplant outcome--importance of death with function. Transplantation. 1993 Apr;55(4):757-61. doi: 10.1097/00007890-199304000-00014.
- Cecka JM, Terasaki PI. The UNOS Scientific Renal Transplant Registry. Clin Transpl. 1993:1-18.
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
Otros números de identificación del estudio
- 990107
- 99-DK-0107
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