Chronic Kidney Disease in Pakistani Population (CKD)

December 8, 2008 updated by: Aga Khan University

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
GFR will be measured as the mean of at least two urinary clearance periods of Inulin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

National Institutes of Health (NIH)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

December 1, 2008

First Submitted That Met QC Criteria

December 1, 2008

First Posted (Estimate)

December 2, 2008

Study Record Updates

Last Update Posted (Estimate)

December 9, 2008

Last Update Submitted That Met QC Criteria

December 8, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R03TW007588 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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