Chronic Kidney Disease in Pakistani Population

NCT ID: NCT00800878

Last Updated: 2008-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Chronic Kidney Disease Renal insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aga Khan University

OTHER

Sponsor Role lead

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aga Khan University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tazeen H Jafar, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aga Khan University

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tazeen H Jafar, MD, MPH

Role: CONTACT

Phone: 92 21 4930051

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R03TW007588

Identifier Type: NIH

Identifier Source: org_study_id

View Link