Chronic Kidney Disease Clinical Trial
— VCOROfficial title:
A Phase IV, Randomized, Single-center Study of the Effects of Calcitriol and Paricalcitol on Vascular Calcification in Chronic Kidney Disease Stages 3 and 4
Verified date | December 2017 |
Source | Joslin Diabetes Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with chronic kidney disease (CKD) have a higher mortality rate than the general
population, with cardiovascular disease (CVD) accounting for approximately 50% of deaths.
Vascular calcification is a common finding in patients with CKD. Furthermore, patients with
CKD develop secondary hyperparathyroidism, partly because of a decrease of calcitriol
synthesis on the kidney. Treatment of secondary hyperparathyroidism includes use of activated
vitamin D including calcitriol and paricalcitol. Recent evidence in dialysis patients suggest
an improved survival in patients using paricalcitol compared to calcitriol.
Studies in uremic rats suggests that there are differential effects of calcitriol and
paricalcitol in expression of markers of soft-tissue calcification independent of
calcium-phosphorus product. Calcitriol increased calcification of vascular smooth muscle
cells cultured in calcification media. There was also significant increase in pulse pressure
in animals treated with calcitriol.
The investigators hypothesize that these different forms of vitamin D may have differential
effects in vascular calcification progression in CKD patients.
Status | Completed |
Enrollment | 44 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years and older |
Eligibility |
Inclusion Criteria: - CKD stages 3 or 4 (estimated glomerular filtration rate (eGFR) between 15 and 59) - Diagnosis of secondary hyperparathyroidism, which is defined as: - Elevated intact PTH (iPTH) as per KDIGO guidelines: - CKD stage 3 (eGFR 30-59) or CKD stage 4 (eGFR 15-29) with iPTH > Upper Limit of Normal for lab (6.8 pmol/L) - Presence of Coronary Artery Calcium (CAC > 0) - Subject will be able to complete the study, to the best of his/her knowledge Exclusion Criteria: - iPTH >1500 pg/ml - Current or previous use of bisphosphonates - History of parathyroidectomy or anticipated parathyroidectomy - History of cinacalcet use - History of a solid organ transplant or scheduled date for transplant surgery - History of coronary revascularization (coronary artery bypass surgery or percutaneous intervention) - History of coronary artifact (e.g. pacemaker, intracardiac defibrillator, artificial valve or biventricular leads) - Active atrial fibrillation - Weight greater than 300 pounds (due to limitations of equipment) - HIV positive - Current pregnancy (although pregnancy is very rare in the CKD population) - Life expectancy less than two years as judged by primary physician - Institutionalized patients (nursing home or prisoners) - Language barrier or mental incapacity to consent - Inability to swallow tablets or current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications. |
Country | Name | City | State |
---|---|---|---|
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Joslin Diabetes Center | Abbott |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Coronary Artery (CAC) Score Progression | coronary artery (CAC) score difference between baseline and followup CT scans. It was measured in Agatston units. These are units of amount of calcification in the blood vessels so it's a continuous variable. The amount of calcium was quantified with the Agatston scoring method. Calcium scores were adjusted with a standard calcium phantom that was scanned along with the participant. The phantom contained known calcium density bars and provided a way to calibrate the x-ray attenuation level. Participants scoring CAC >400 are considered to be at risk for having at least one coronary lesion. |
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