Chronic Kidney Disease in Pakistani Population (CKD)
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | December 1, 2008 | ||||
| Last Updated Date | December 8, 2008 | ||||
| Start Date ICMJE | February 2008 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
GFR will be measured as the mean of at least two urinary clearance periods of Inulin [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00800878 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Chronic Kidney Disease in Pakistani Population | ||||
| Official Title ICMJE | Chronic Kidney Disease in the Pakistani Population | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Cross-Sectional | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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 |
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| Condition ICMJE | Chronic Kidney Disease | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 650 | ||||
| Estimated Completion Date | April 2010 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Pakistan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00800878 | ||||
| Other Study ID Numbers ICMJE | R03TW007588 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Tazeen H Jafar, Aga Khan University | ||||
| Study Sponsor ICMJE | Aga Khan University | ||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||
| Investigators ICMJE |
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| Information Provided By | Aga Khan University | ||||
| Verification Date | November 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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