Overview

This trial is active, not recruiting.

Condition chronic kidney disease
Sponsor United States Naval Medical Center, San Diego
Collaborator Genzyme, a Sanofi Company
Start date February 2004
End date September 2005
Trial size 200 participants
Trial identifier NCT00142636, CIP #S-03-133, CRADA CIP # S-03-133

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model defined population
Primary purpose screening
Time perspective longitudinal

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - Ages <18 or >65 years - Pregnant subjects - Subjects with history of severe obstructive pulmonary disease, CHF, stroke, arrythmia. - Dialysis and kidney transplant patients.

Additional Information

Official title Coronary Artery Calcification in Chronic Kidney Disease Using Multidetector Row Spiral Computed Tomography
Principal investigator Dylan E Wessman, M.D.
Description 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) were recruited from the Nephrology Clinic, and the control subjects (GFR >/=60ml/min) were recruited from the Internal Medicine Clinic. 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. These observations suggest that CAC begins in earlier stages of CKD. Moreover, novel CVD risk factors including iPTH may accelerate CAD progression in CKD.
Trial information was received from ClinicalTrials.gov and was last updated in November 2005.
Information provided to ClinicalTrials.gov by United States Naval Medical Center, San Diego.