Vitamin D and Coronary Calcification Study - Tabular View

Tracking Information

First Received Date ^ICMJE

September 11, 2008

Last Updated Date

March 25, 2009

Start Date ^ICMJE

September 2008

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00752102 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Vitamin D and Coronary Calcification Study

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Condition ^ICMJE

Chronic Kidney Disease
Vitamin D
Coronary Calcification
Bone Metabolism

Intervention ^ICMJE

Drug: Calcitriol (Rocaltrol®)
Drug: Paricalcitol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2011

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 NKF guidelines:
  - CKD stage 3 (eGFR 30-59) with iPTH >7.7 pmol/L (70 pg/ml), calcium <9.5, and phosphorus <4.6
  - CKD stage 4 (eGFR 15-29) with iPTH >12.1 pmol/L (110 pg/ml)
CAC score >10
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 myocardial infarction
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.

Gender

Both

Ages

35 Years to 74 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Philip T Cochetti	215-615-3848	philip.cochetti@uphs.upenn.edu
Contact: Katharine Schankel	215-615-3848	katharine.schankel@uphs.upenn.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00752102

Responsible Party

Sylvia E. Rosas, MD, MSCE, University of Pennsylvania

Study ID Numbers ^ICMJE

Abbott #20128

Study Sponsor ^ICMJE

University of Pennsylvania

Collaborators ^ICMJE

Abbott

Investigators ^ICMJE

Principal Investigator:

Sylvia E Rosas, MD, MSCE

University of Pennsylvania

Information Provided By

University of Pennsylvania

Verification Date

March 2009

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