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Vitamin D and Coronary Calcification Study (VCOR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Pennsylvania.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00752102
First received: September 11, 2008
Last updated: November 14, 2011
Last verified: November 2011

September 11, 2008
November 14, 2011
September 2008
October 2012   (final data collection date for primary outcome measure)
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. [ Time Frame: Baseline and week 48 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00752102 on ClinicalTrials.gov Archive Site
  • 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. [ Time Frame: Baseline and week 48 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Baseline and week 48 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vitamin D and Coronary Calcification Study
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Chronic Kidney Disease
  • Vitamin D Deficiency
  • Coronary Calcification
  • Disorders of Calcium and Bone Metabolism
  • Drug: Calcitriol (Rocaltrol®)
    Subjects taking calcitriol will be started at 0.25 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then calcitriol will be increased to 0.5 mcg 3x/week.
    Other Names:
    • Calcijex®
    • Rocaltrol®
  • Drug: Paricalcitol
    Subjects taking paricalcitol will be started at 2 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then paricalcitol will be increased to 4 mcg 3x/week.
    Other Name: Zemplar®
  • Active Comparator: Calcitriol
    Intervention: Drug: Calcitriol (Rocaltrol®)
  • Active Comparator: Paricalcitol
    Intervention: Drug: Paricalcitol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2013
October 2012   (final data collection date for primary outcome measure)

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.
Both
25 Years and older
No
Contact: Philip T Cochetti 215-615-3848 philip.cochetti@uphs.upenn.edu
Contact: Christine Bonney 215-615-3848 christine.bonney@uphs.upenn.edu
United States
 
NCT00752102
Abbott #20128
No
University of Pennsylvania
University of Pennsylvania
Abbott
Principal Investigator: Sylvia E Rosas, MD, MSCE University of Pennsylvania
University of Pennsylvania
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP