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Completed No phase listed Observational Accepts healthy volunteers

ADMA Levels in End-Stage Renal Disease

ClinicalTrials.gov ID: NCT00350974

Public ClinicalTrials.gov record NCT00350974. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 28, 2026, 1:59 PM EDT

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Official title

Determination of Asymmetrical Dimethylarginine (ADMA) Accumulation in End Stage Renal Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00350974
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
University of Michigan
Other
Enrollment
61 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2006
Primary completion
Mar 7, 2007
Completion
Mar 7, 2007
Last update posted
Jun 4, 2017

2006 – 2007

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Michigan Health System Ann Arbor Michigan 48109 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00350974, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 4, 2017 · Synced Sep 28, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00350974 live on ClinicalTrials.gov.

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