Study of Anemia in Chronic Kidney Disease (CKD) Among High-Risk Hypertensive and Diabetic Patients in Pakistan

March 19, 2018 updated by: Hoffmann-La Roche

Prevalence of Anaemia Secondary to Early Stage Chronic Kidney Disease in High Risk Diabetic and/or Hypertensive Population

The purpose of this study is to evaluate the prevalence of CKD-related anemia at an early stage through screening of high-risk patients in Pakistan at the level of physicians, cardiologists, and diabetologists. The information gathered may serve as a foundation in formulating national guidelines for better early diagnosis and management of patients with CKD.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

246

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan
      • Karachi, Pakistan
      • Lahore, Pakistan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will enroll high-risk hypertensive and/or diabetic patients in Pakistan who meet eligibility criteria for observation.

Description

Inclusion Criteria:

  • Age greater than or equal to 40 years
  • Known hypertension and/or diabetes for at least 3 years
  • Positive dipstick test result for proteinuria

Exclusion Criteria:

  • Known CKD
  • Receiving erythropoietin
  • Blood transfusion within 8 weeks
  • History of acute or chronic bleeding, hemolysis, or hemoglobinopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Study Population
Hypertensive and diabetic patients who meet eligibility criteria will be enrolled and evaluated for the presence of anemia secondary to CKD. The first visit will capture medical history including risk factors for CKD; laboratory assessments will be performed at the second and third visits to evaluate glomerular filtration rate (eGFR) and anemia profile, respectively. Participants who are not diagnosted with CKD based upon the second visit will not return for the third visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with anemia secondary to CKD
Time Frame: Up to 12 months
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Use of treatment modalities for the management of anemia secondary to CKD
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

May 12, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 15, 2015

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML27762

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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