Trial Outcomes & Findings for Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease (NCT NCT00285467)

Results Overview

Percent reduction in PTH from baseline to 3 months

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

55 participants

Primary outcome timeframe

3 month

Results posted on

2016-05-02

Participant Flow

Participant milestones

Participant milestones
Measure	Doxercalciferol, Active Vitamin D Doxercalciferol is an active Vitamin D readily usable by human body.	Cholecalciferol, Inactive Vitamin D Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
Overall Study STARTED	25	22
Overall Study COMPLETED	25	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Doxercalciferol, Active Vitamin D n=25 Participants Doxercalciferol is an active Vitamin D readily usable by human body.	Cholecalciferol, Inactive Vitamin D n=22 Participants Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.	Total n=47 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 10 • n=5 Participants	62 years STANDARD_DEVIATION 10 • n=7 Participants	63.5 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	22 participants n=7 Participants	47 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 month

Population: The initial sample size was based on the published response to doxercalciferol versus placebo where a 46% reduction in PTH was observed over 6 months, with a 51% SD. The expected reduction in PTH with cholecalciferol was based on the best-case scenario decrease of 17.8% in PTH with ergocalciferol from our own clinic setting.

Percent reduction in PTH from baseline to 3 months

Outcome measures

Outcome measures
Measure	Doxercalciferol, Active Vitamin D n=25 Participants Doxercalciferol is an active Vitamin D readily usable by human body.	Cholecalciferol, Inactive Vitamin D n=22 Participants Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
Percent Reduction in PTH	27 % change in PTH baseline to 3 months Standard Deviation 34	10 % change in PTH baseline to 3 months Standard Deviation 31

SECONDARY outcome

Timeframe: 3 month

systolic blood pressure at 3 months

Outcome measures

Outcome measures
Measure	Doxercalciferol, Active Vitamin D n=25 Participants Doxercalciferol is an active Vitamin D readily usable by human body.	Cholecalciferol, Inactive Vitamin D n=22 Participants Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
Systolic Blood Pressure at 3 Months	120 mmHg Standard Deviation 47	128 mmHg Standard Deviation 33

Adverse Events

Doxercalciferol, Active Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cholecalciferol, Inactive Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sharon Moe, MD

Indiana University School of Medicine

Phone: 317-278-2868

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place