ADMA Levels in End-Stage Renal Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00350974
First received: July 10, 2006
Last updated: December 1, 2006
Last verified: December 2006
  Purpose

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.


Condition
Chronic Kidney Disease
Hypertension

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion

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

Exclusion

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350974

Contacts
Contact: Kathryn M Lindblad, RN,MS.CCRC 734-377-2973 lindblad@umich.edu
Contact: Melisa Rippee 734-615-3994 rippee@umich.edu

Locations
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
Investigators
Principal Investigator: Crystal A Gadegbeku, MD University of Michigan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00350974     History of Changes
Other Study ID Numbers: HUM 0000 4194
Study First Received: July 10, 2006
Last Updated: December 1, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 20, 2014