NCT00142636

Brief Summary

Patients with Chronic Kidney Disease (CKD) have been shown to have high coronary calcium scores (CAC), but the temporal association between Glomerular Filtration Rate, CVD risk factors and CAC has not been described. This is a single-center, longitudinal, observational study. Subjects included adults aged 18 years to 65 years old without preexisting coronary artery disease (CAD). The CKD subjects (GFR \< 60 ml/min) and the control subjects (GFR \>/=60ml/min) were recruited. Laboratory measurements and MDCT scan were performed at baseline and after 12 months. Baseline CAC and average intact parathyroid hormone (iPTH) level were significantly greater in the CKD group. Baseline CAC scores of the CKD group were twice the value of the control group; however, CAC scores over one year were unchanged from baseline.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

First QC Date

September 1, 2005

Last Update Submit

July 29, 2025

Conditions

Chronic Kidney Disease

Keywords

Chronic Kideny DiseaseHypertension

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and Female ages 18 to 65 years
  • Chronic Kidney disease patients, GFR \<60mL/min as defined by MDRD (Levey) formula.
  • Healthy volunteer controls, GFR \>/= 60 mL/min
  • Signed, written informed consent

You may not qualify if:

  • Ages \<18 or \>65 years
  • Pregnant subjects
  • Subjects with history of severe obstructive pulmonary disease, CHF, stroke, arrythmia.
  • Dialysis and kidney transplant patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Related Publications (1)

  • Dylan Wessman, M.D., Sandra Gilbert, Frank Mullens, M.D., Robin Parker, M.D., John Hammes, M.D., Lou Brenner, M.D. and Amit Sharma, M.D.

    RESULT

MeSH Terms

Conditions

Renal Insufficiency, ChronicHypertension

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Study Officials

  • Dylan E Wessman, M.D.

    Naval Medical Center, San Diego, Department of Internal Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

February 1, 2004

Study Completion

September 1, 2005

Last Updated

August 1, 2025

Record last verified: 2025-07

Locations

US(1)