Pre-ESRD Syndrome in High Risk African Americans

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ClinicalTrials.gov Identifier: NCT00224939

Recruitment Status : Terminated (Only apx 1/3 of enrolled subjects (signed consent) participated. Futility analysis to show primary endpoint)

First Posted : September 23, 2005

Last Update Posted : January 14, 2010

Sponsor:

Information provided by:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information

First Submitted Date ^ICMJE

September 21, 2005

First Posted Date ^ICMJE

September 23, 2005

Last Update Posted Date

January 14, 2010

Study Start Date ^ICMJE

July 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pre-ESRD Syndrome in High Risk African Americans

Official Title ^ICMJE

Pre-ESRD Syndrome in High Risk African American Young Adults

Brief Summary

Evaluation of the dipping status of blood pressure (wether blood pressure decreases at night) and renal functional reserve and wether non-dippers (those whose blood pressure does not decrease at night) can be modulated to dippers with potassium treatment.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention

Condition ^ICMJE

Blood Pressure

Intervention ^ICMJE

Drug: Potassium Chloride

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

144

Original Enrollment ^ICMJE

Same as current

Actual Study Completion Date ^ICMJE

December 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria: 18-35, healthy volunteers, African American

Exclusion Criteria: Active medical conditions, prescription drug therapy other than birth control

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 35 Years (Adult)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00224939

Other Study ID Numbers ^ICMJE

DK 62714 (terminated)

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Elizabeth B Ripley, MD

Virginia Commonwealth University

PRS Account

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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