Chronic Kidney Disease in Pakistani Population (CKD)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease
Chronic Kidney Disease

Detailed Description:

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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	650 participants
Time Perspective:	Cross-Sectional
Official Title:	Chronic Kidney Disease in the Pakistani Population
Study Start Date :	February 2008
Estimated Primary Completion Date :	December 2009
Estimated Study Completion Date :	April 2010

Groups and Cohorts

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Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. GFR will be measured as the mean of at least two urinary clearance periods of Inulin

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

All individuals aged aged 40 years and above in a representative sample of Karachi Demographic Survey constituted the sampling frame. Individuals were screened for hypertension and diabetes and the final sample of about 650 subjects will be randomly selected

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Tazeen H Jafar, MD, MPH	92 21 4930051 ext 4812	tazeen.jafar@aku.edu

Locations

Pakistan
Aga Khan University	Recruiting
Karachi, Sindh, Pakistan, 74800

Sponsors and Collaborators

Aga Khan University

National Institutes of Health (NIH)

Investigators

Principal Investigator:	Tazeen H Jafar, MD, MPH	Aga Khan University

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Tazeen H Jafar, Aga Khan University
ClinicalTrials.gov Identifier:	NCT00800878 History of Changes
Other Study ID Numbers:	R03TW007588 ( U.S. NIH Grant/Contract )
First Posted:	December 2, 2008
Last Update Posted:	December 9, 2008
Last Verified:	November 2008

Keywords provided by Aga Khan University:

Chronic Kidney Disease; Renal insufficiency

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Renal Insufficiency