CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 44 enrolled
Drug / intervention
Calcitriol (Rocaltrol®) +1 moredrug
Likely dose
Calcitriol (Rocaltrol®) 0.25 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00752102
NCT00752102Phase 4Completed

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

Joslin Diabetes Center·interventional·Posted Sep 15, 2008·Updated Dec 8, 2017

In Brief

A Phase 4 clinical trial evaluating Calcitriol (Rocaltrol®) and Paricalcitol for Chronic Kidney Disease and 3 related conditions. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAbbott

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 15, 2008
Enrollment StartSep 1, 2008
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 17.8 years ago

Interventions

Calcitriol (Rocaltrol®)drug

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.

Paricalcitoldrug

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.