Chronic Kidney Disease in Pakistani Population (CKD)
Recruitment status was Recruiting
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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 |
- 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) |
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 |
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
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00800878
| Contact: Tazeen H Jafar, MD, MPH | 92 21 4930051 ext 4812 | tazeen.jafar@aku.edu |
| Pakistan | |
| Aga Khan University | Recruiting |
| Karachi, Sindh, Pakistan, 74800 | |
| 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 Renal Insufficiency Urologic Diseases |
ClinicalTrials.gov processed this record on February 27, 2015