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
  Purpose

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
Chronic Kidney Disease

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Chronic Kidney Disease in the Pakistani Population

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • GFR will be measured as the mean of at least two urinary clearance periods of Inulin [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: February 2008
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Tazeen H Jafar, MD, MPH Aga Khan University
  More Information

No publications provided

Responsible Party: Tazeen H Jafar, Aga Khan University
ClinicalTrials.gov Identifier: NCT00800878     History of Changes
Other Study ID Numbers: R03TW007588
Study First Received: December 1, 2008
Last Updated: December 8, 2008
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:
Chronic Kidney Disease
Renal insufficiency

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 18, 2014