Genetic Analysis of Human Hypertensive End Stage Renal Disease (H-ESRD)

May 12, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To identify genes causing hypertensive end-stage renal disease (H-ESRD) in high risk African-American populations

Study Overview

Status

Completed

Conditions

Detailed Description

BACKGROUND:

Although hypertension is a predisposing factor for end stage renal disease, the underlying hypothesis of this study was that in select African-American families genetic factors predisposed them to develop ESRD in the face of hypertension. An inherited basis for H-ESRD was supported by familial clustering of H-ESRD among African Americans that could not be explained by socioeconomic status, access to medical care, and the prevalence of diabetes and hypertension.

DESIGN NARRATIVE:

DNA samples were collected, identified, and clinically characterized from African-American sib-pairs (and other family members with hypertensive end-stage renal disease). This aspect of the study was based on the fact that Dr. Freedman, the principal investigator, had already developed a unique "family history of end-stage renal disease" database independently funded by the End-Stage Renal Disease Network Six. This registry served as a very large and unique collection of African-American end-stage renal disease patients. He began with a candidate gene approach for linkage to hypertensive end-stage renal disease in his patient samples using a variety of growth factor genes, genes involved in sodium transport and vascular tone, as well as human homologues of rodent genes that had, or were to be identified in the future as contributing to ESRD in that organism. If this initial first pass of candidate genes failed to demonstrate linkage to hypertensive end-stage renal disease, a systematic genome-wide scan was to be performed with available simple sequence length polymorphisms (SSLP) and other polymorphic markers. Hypertensive end-stage renal disease is a condition of enormous clinical and economic importance and identification of associated or causative renal-failure genes would form a genetic basis for the detection of high-risk individuals and assist in development of intervention and treatment strategies to prevent this condition.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Type

Observational

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

No older than 100 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

No eligibility criteria

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?

Collaborators and Investigators

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

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Barry Freedman, Wake Forest University

Publications and helpful links

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General Publications

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

July 1, 1997

Study Completion (ACTUAL)

June 1, 2003

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (ESTIMATE)

May 26, 2000

Study Record Updates

Last Update Posted (ESTIMATE)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

March 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5069
  • R01HL056266 (NIH)

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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