ADMA Levels in End-Stage Renal Disease

NCT00350974 | Completed

• 1 other identifier: HUM00004194
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Chronic Kidney Disease; Hypertension

Study Arms (3)

End-stage Renal Disease

on maintenance hemodialysis 3 x per week for more than 12 months

No kidney disease

eGFR greater than 60 ml/Min

Hypertensive group

Blood pressure greater than 130/80

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Three groups: 16 healthy control subjects (CO), 18 patients with ESRD and 18 matched hypertensive patients with normal renal function (HTN).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Renal Research Institute: collaborator

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Crystal A Gadegbeku, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine, Nephrology

Study Record Dates

• First Submitted: July 10, 2006
• First Posted: July 11, 2006
• Study Start: July 1, 2006
• Primary Completion: March 8, 2007
• Study Completion: March 8, 2007
• Last Updated: June 5, 2017

Record last verified: 2017-06

Locations

US (1)