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ADMA Levels in End-Stage Renal Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by University of Michigan.
Recruitment status was:  Recruiting
Information provided by:
University of Michigan Identifier:
First received: July 10, 2006
Last updated: December 1, 2006
Last verified: December 2006

Asymmetric dimethylarginine, ADMA, in plasma, is significantly elevated in patients with renal disease and associated with cardiovascular morbidity and mortality. We found that whole blood (WB) possesses the metabolic pathways required for both the generation and elimination of ADMA and we have developed ex vivo methods to assess the WB accumulation of ADMA in humans. The over-arching hypothesis is that dysregulation of ADMA metabolic pathways leads to greater ADMA whole blood content and greater capacity to accumulate ADMA, which 1) is not reflected by plasma levels and 2) is a better predictor of cardiovascular outcome than plasma levels in end-stage renal disease (ESRD). The following specific aims will be pursued to characterize whole blood ADMA in ESRD:

  1. Compare and contrast baseline free plasma ADMA and total whole blood (free plus protein-incorporated) ADMA concentrations in ESRD patients, matched hypertensive controls and a normal population.
  2. Determine the capacity of WB to accumulate (the net balance of generation and elimination) ADMA in ESRD patients, matched hypertensive controls and a normal population.

We will use state-of-the-art, high performance liquid chromatography techniques to measure ADMA levels in plasma and whole blood. Samples for ADMA measurements will be obtained from subjects with end-stage renal disease immediately before their dialysis treatments. Samples will also be obtained from volunteers without kidney disease. This group will be matched to the end-stage renal volunteers by age, gender and ethnicity. These volunteers will also be matched for the presence of hypertension and diabetes. The third group will consist of a normal population to measure the normal levels of ADMA and compare to the other two groups.

There is growing evidence to support a pathological role of ADMA in humans. These experiments will enhance our understanding of how ADMA is processed in the human body and how it is associated with kidney disease. Potentially, these results will lay the groundwork for new insights into the link between ADMA and the high cardiovascular disease burden in patients with kidney disease.

Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Determination of Asymmetrical Dimethylarginine (ADMA) Accumulation in End Stage Renal Disease

Resource links provided by NLM:

Further study details as provided by University of Michigan:

Estimated Enrollment: 63
Study Start Date: July 2006
Estimated Study Completion Date: June 2007

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


Group 1:

  • are now 18 years of age or older, with end-stage renal disease (ESRD)
  • have been on maintenance hemodialysis therapy three times/week for more then 12 months

Group 2 criteria:

  • are now 18 years of age or older
  • can be matched to a volunteer in Group 1 for age, gender, race, blood pressure and diabetes history
  • have an eGFR greater then 60 ml/min (This is a value based on a laboratory blood test that shows how well your kidneys work.)

Group 3 criteria:

  • are now 18 years of age or older
  • have blood pressure less than 130/80 when you are not taking blood pressure medication
  • normal kidney function


  • are less then 18 years of age
  • are pregnant or breast feeding
  • unable or unwilling to provide informed consent
  • are currently in another study
  • have a hemoglobin (substance in red blood cells that carries oxygen) level that is less than 8 mg/dl
  • have an untreated infection that won’t go away
  • require admission to the hospital
  • have a history of hemolytic diseases (e.g. sickle cell disease)
  • appear unlikely or unable to participate in the required study procedures
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Please refer to this study by its identifier: NCT00350974

Contact: Kathryn M Lindblad, RN,MS.CCRC 734-377-2973
Contact: Melisa Rippee 734-615-3994

United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Crystal A Gadegbeku, MD         
Sponsors and Collaborators
University of Michigan
Principal Investigator: Crystal A Gadegbeku, MD University of Michigan
  More Information Identifier: NCT00350974     History of Changes
Other Study ID Numbers: HUM 0000 4194
Study First Received: July 10, 2006
Last Updated: December 1, 2006

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases processed this record on April 26, 2017