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Chronic Kidney Disease in Pakistani Population (CKD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Aga Khan University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00800878
First received: December 1, 2008
Last updated: December 8, 2008
Last verified: November 2008

December 1, 2008
December 8, 2008
February 2008
December 2009   (final data collection date for primary outcome measure)
GFR will be measured as the mean of at least two urinary clearance periods of Inulin [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00800878 on ClinicalTrials.gov Archive Site
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Chronic Kidney Disease in Pakistani Population
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.

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.

Observational
Time Perspective: Cross-Sectional
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Probability Sample

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

Chronic Kidney Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
650
April 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact: Tazeen H Jafar, MD, MPH 92 21 4930051 ext 4812 tazeen.jafar@aku.edu
Pakistan
 
NCT00800878
R03TW007588
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Tazeen H Jafar, Aga Khan University
Aga Khan University
National Institutes of Health (NIH)
Principal Investigator: Tazeen H Jafar, MD, MPH Aga Khan University
Aga Khan University
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP