Trial Outcomes & Findings for Vascular Reactivity in Chronic Kidney Disease (CKD) Patients Receiving Paricalcitol Versus Placebo (NCT NCT00915876)

Results Overview

Values of ICAM-1 (intracellular adhesion molecule) a measure of vascular reactivity, at three time points: baseline, day 28, and day 56

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

Day 28 and Day 56

Results posted on

2016-12-02

Participant milestones
Measure	Paricalcitol Paricalcitol: paricalcitol 1 mcg QD x 8 weeks	Placebo Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
Overall Study STARTED	20	21
Overall Study Moving Beyond First Dose	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal
Measure	Paricalcitol Paricalcitol: paricalcitol 1 mcg QD x 8 weeks	Placebo Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
Overall Study Adverse Event	0	1

Vascular Reactivity in Chronic Kidney Disease (CKD) Patients Receiving Paricalcitol Versus Placebo

Baseline characteristics by cohort
Measure	Placebo n=20 Participants Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks	Paricalcitol n=20 Participants Paricalcitol: paricalcitol 1 mcg QD x 8 weeks	Total n=40 Participants Total of all reporting groups
Age, Continuous	67 years STANDARD_DEVIATION 11 • n=5 Participants	64 years STANDARD_DEVIATION 14 • n=7 Participants	66 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants
estimated glomerular filtration rate	36 mL/min/1.73m2 STANDARD_DEVIATION 11 • n=5 Participants	30 mL/min/1.73m2 STANDARD_DEVIATION 9 • n=7 Participants	35 mL/min/1.73m2 STANDARD_DEVIATION 10 • n=5 Participants

Timeframe: Day 28 and Day 56

Values of ICAM-1 (intracellular adhesion molecule) a measure of vascular reactivity, at three time points: baseline, day 28, and day 56

Outcome measures
Measure	Placebo n=20 Participants Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks	Paricalcitol n=20 Participants Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56 Baseline	707 nanogram/ml Standard Deviation 504	701 nanogram/ml Standard Deviation 603
Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56 Day 28	679 nanogram/ml Standard Deviation 557	627 nanogram/ml Standard Deviation 570
Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56 Day 56	590 nanogram/ml Standard Deviation 458	477 nanogram/ml Standard Deviation 382

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Placebo n=21 participants at risk Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks	Paricalcitol n=20 participants at risk Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
Nervous system disorders Weakness	4.8% 1/21 • Number of events 1 • TENTATIVE: 7 weeks of intervention and 30 days of followup, totalling up to 12 weeks per person	0.00% 0/20 • TENTATIVE: 7 weeks of intervention and 30 days of followup, totalling up to 12 weeks per person

University of Michigan

Phone: 7346470005