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Chronic Kidney Disease in Pakistani Population (CKD)

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ClinicalTrials.gov Identifier: NCT00800878
Recruitment Status : Unknown
Verified November 2008 by Aga Khan University.
Recruitment status was:  Recruiting
First Posted : December 2, 2008
Last Update Posted : December 9, 2008
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Aga Khan University

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Groups and Cohorts
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Outcome Measures
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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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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800878


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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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    Key Record Dates
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