- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00800878
Chronic Kidney Disease in Pakistani Population (CKD)
Chronic Kidney Disease in the Pakistani Population
The Indo-Asian developing countries are facing an epidemic of chronic diseases including hypertension, diabetes and chronic kidney disease (CKD). Diagnosis of early CKD is essential for institution of effective and timely prevention of its complications; costly late stage treatment for end stage renal disease is currently an unfeasible option in these populations. GFR estimates of kidney function provide a common reference standard for all people and are therefore readily applicable by physicians and understood by patients. However, the existing GFR equations yield widely discrepant results in the Indo Asian population, and none of the currently available estimating equations have been validated in this population.
The main objective is to develop a tool which can be used for screening subjects at high risk for developing CKD (with hypertension and diabetes) as well as the general population.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The proposed study is being conducted at the Aga Khan University in collaboration with Tufts-New England Medical Center and Imperial College, UK. It is a population based cross-sectional study using a 2-stage cluster design. The study would be performed on 650 adult subjects from the general population in Karachi.
A new GFR equation specific to a Pakistani population would be developed and validated using the gold standard of measured Insulin GFR. The performance of the new equation will be compared to the existing ones developed in other populations with respect to bias, precision, and accuracy.
The project is likely to contribute significantly to moving the field to kidney disease forward, and its results are likely to have far reaching implications for understanding of CKD and, ultimately, its prevention in Indo-Pakistani populations worldwide.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Tazeen H Jafar, MD, MPH
- Número de teléfono: 4812 92 21 4930051
- Correo electrónico: tazeen.jafar@aku.edu
Ubicaciones de estudio
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Sindh
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Karachi, Sindh, Pakistán, 74800
- Reclutamiento
- Aga Khan University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- All individuals aged 40 years and above
Exclusion Criteria:
- Shortness of breath on minimal to moderate exertion
- Acute fibril illness
- Doctor diagnosed liver disease
- Doctor diagnosed rheumatological disease
- Heart attack within past three months
- Pregnancy
- Mentally incompetent to give informed consent
- Too frail to travel to clinic
- Bed ridden subjects
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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GFR will be measured as the mean of at least two urinary clearance periods of Inulin
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Tazeen H Jafar, MD, MPH, Aga Khan University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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 (Estimar)
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
- R03TW007588 (Subvención/contrato del NIH de EE. UU.)
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