Chronic Kidney DiseaseCKDNCT00800878
Chronic Kidney Disease in Pakistani Population
An observational study of Chronic Kidney Disease, run by Aga Khan University at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 650 participants
- Where
- 1 sitePakistan
- Study dates
- Feb 2008to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- All individuals aged 40 years and above
Who cannot join
- 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
Show all 9Show fewer
- Mentally incompetent to give informed consent
- Too frail to travel to clinic
- Bed ridden subjects
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, Sindh, 74800
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Renal insufficiency
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
GFR will be measured as the mean of at least two urinary clearance periods of Inulin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2009 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Tazeen H Jafar, MD, MPH, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800878
- Sponsor's protocol ID
- R03TW007588
- Acronym
- CKD
- Status last verified
- Nov 2008
- First submitted
- 1 Dec 2008
- Last updated
- 9 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Kidney Disease in the Pakistani Population
- ClinicalTrials.gov ID
- NCT00800878
- Acronym / sponsor ID
- CKD / R03TW007588
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Renal insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Feb 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 2 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All individuals aged 40 years and above
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GFR will be measured as the mean of at least two urinary clearance periods of Inulin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tazeen H Jafar, MD, MPH principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tazeen H Jafar, MD, MPH (92 21 4930051 ext. 4812, tazeen.jafar@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GFR will be measured as the mean of at least two urinary clearance periods of Inulin. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2008.