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Vitamin D and Coronary Calcification Study

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease; Vitamin D Deficiency; Coronary Calcification; Disorders of Calcium and Bone Metabolism

Intervention: Calcitriol (Rocaltrol®) (Drug); Paricalcitol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Sylvia E Rosas, MD, MSCE, Principal Investigator, Affiliation: University of Pennsylvania

Overall contact:
Philip T Cochetti, Phone: 215-615-3848, Email: philip.cochetti@uphs.upenn.edu

Summary

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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: To determine prospectively if there is a differential effect on coronary artery (CAC) score progression between calcitriol and paricalcitol in patients with chronic kidney disease.

Secondary outcome:

To determine prospectively if there is a differential effect on aortic and valvular score progression and arterial stiffness in patients with chronic kidney disease receiving calcitriol and paricalcitol.

To determine prospectively if there is a differential effect on biomarkers of vascular calcification and mineral metabolism in patients with chronic kidney disease receiving calcitriol and paricalcitol.

Eligibility

Minimum age: 25 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Philip T Cochetti, Phone: 215-615-3848, Email: philip.cochetti@uphs.upenn.edu

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19107, United States; Recruiting
Sylvia E Rosas, MD, MSCE, Principal Investigator
Additional Information

Starting date: September 2008
Last updated: November 14, 2011

Page last updated: August 23, 2015

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