Chronic Kidney Disease in Pakistani Population

Chronic Kidney Disease Clinical Trial

— CKD  

Official title:

Chronic Kidney Disease in the Pakistani Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00800878
• Other study ID #: R03TW007588
• Status: Recruiting
• Phase: N/A
• First received: December 1, 2008
• Last updated: December 8, 2008
• Start date: February 2008
• Est. completion date: April 2010

Study information

• Verified date: November 2008
• Source: Aga Khan University
• Contact: Tazeen H Jafar, MD, MPH
• Phone: 92 21 4930051
• Email: tazeen.jafar[@]aku.edu
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Aga Khan University	National Institutes of Health (NIH)

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GFR will be measured as the mean of at least two urinary clearance periods of Inulin			No