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
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Vitamin D Deficiency
Coronary Calcification
Disorders of Calcium and Bone Metabolism
Drug: Calcitriol (Rocaltrol®)
Drug: Paricalcitol
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Calcitriol 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®
Active Comparator: Paricalcitol 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®

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752102

Contacts
Contact: Philip T Cochetti 215-615-3848 philip.cochetti@uphs.upenn.edu
Contact: Christine Bonney 215-615-3848 christine.bonney@uphs.upenn.edu

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Sylvia E Rosas, MD, MSCE         
Sponsors and Collaborators
University of Pennsylvania
Abbott
Investigators
Principal Investigator: Sylvia E Rosas, MD, MSCE University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00752102     History of Changes
Other Study ID Numbers: Abbott #20128
Study First Received: September 11, 2008
Last Updated: November 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Secondary Hyperparathryoidism
Chronic Kidney Disease
Vitamin D
Coronary Calcification
Bone metabolism

Additional relevant MeSH terms:
Calcinosis
Kidney Diseases
Vitamin D Deficiency
Vascular Calcification
Renal Insufficiency, Chronic
Calcium Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Renal Insufficiency
Calcitriol
Vitamin D
Vitamins
Ergocalciferols
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 20, 2014