Trial Outcomes & Findings for How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis (NCT NCT00528788)

Results Overview

Endothelial cell function was assessed by performing flow mediated vasodilatation testing in a vascular laboratory prior to receiving doxercalciferol (either 2 mcg or 4 mcg 3 times per week at hemodialysis) and then after receiving the drug for 30 days.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

1 month

Results posted on

2016-01-22

Participant Flow

We prospectively enrolled 24 hemodialysis patients with secondary hyperparathyroidism into an open-label 30-day observational study.

Participants underwent review of history and meds. Hemodialysis (HD) blood was drawn. seen in vascular laboratory for testing of endothelial cell function and arterial stiffness. Doxercalciferol was initiated at dose of 2 mcg IV 3x/wk or 4 mcg IV 3x/wk. After 30 days of medication, repeat blood drawn and repeat testing in vascular laboratory.

Participant milestones

Participant milestones
Measure	Pre Doxercalciferol/Post Doxercalciferol all end stage renal disease patients with secondary hyperparathyroidism who are vitamin D naive compared pre- and post doxercalciferol.
Overall Study STARTED	24
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pre-post Comparison n=20 Participants ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive doxercalciferol : 2 or 4 mcg
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	50.4 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: prospective open-label 30-day observational study testing the effects of doxercalciferol on mediated vasodilation (FMD) among 20 dialysis pts with secondary hyperparathyroidism

Endothelial cell function was assessed by performing flow mediated vasodilatation testing in a vascular laboratory prior to receiving doxercalciferol (either 2 mcg or 4 mcg 3 times per week at hemodialysis) and then after receiving the drug for 30 days.

Outcome measures

Outcome measures
Measure	Pre-post Comparison n=20 Participants ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive doxercalciferol
Change in Endothelial Cell Function	.23 percent change in FMD Standard Deviation 1.4

Adverse Events

Pre and Post Doxicalciferol

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pre and Post Doxicalciferol n=20 participants at risk ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive doxercalciferol 2 mcg or 4 mcg three times per week for 1 month
Cardiac disorders atypical chest pain	5.0% 1/20 • Number of events 1
Metabolism and nutrition disorders diabetic gastroparesis	5.0% 1/20 • Number of events 1

Other adverse events

Other adverse events
Measure	Pre and Post Doxicalciferol n=20 participants at risk ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive doxercalciferol 2 mcg or 4 mcg three times per week for 1 month
Metabolism and nutrition disorders serum phosphorus 10.4	5.0% 1/20 • Number of events 1

Additional Information

Jula Inrig, MD

Duke University Medical Center

Phone: 919-660-6882

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place