Trial Outcomes & Findings for Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT) (NCT NCT00828347)

NCT ID: NCT00828347

Last Updated: 2016-01-25

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 35 participants
• Primary outcome timeframe: Participants were followed for 24 weeks
• Results posted on: 2016-01-25

Participant Flow

Participant milestones

Measure	High Dose Alfacalcidol oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to \< 150 pg/mL by initial maxacalcitol therapy.	Low Dose Alfacalcidol oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to \< 150 pg/mL by initial maxacalcitol therapy.
Overall Study STARTED	12	11
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)

Baseline characteristics by cohort

Measure	High Dose Alfacalcidol n=12 Participants oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to \< 150 pg/mL by initial maxacalcitol therapy.	Low Dose Alfacalcidol n=11 Participants oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to \< 150 pg/mL by initial maxacalcitol therapy.	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	66.3 years STANDARD_DEVIATION 9.9 • n=5 Participants	69.0 years STANDARD_DEVIATION 13.7 • n=7 Participants	67.7 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment Japan	12 participants n=5 Participants	11 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Participants were followed for 24 weeks

Outcome measures

Measure	High Dose Alfacalcidol n=12 Participants oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to \< 150 pg/mL by initial maxacalcitol therapy.	Low Dose Alfacalcidol n=11 Participants oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to \< 150 pg/mL by initial maxacalcitol therapy.
Number of Participants With iPTH Levels Maintained at the Target Levels of 60-180 pg/mL iPTH Level Controlled cases	10 participants	4 participants
Number of Participants With iPTH Levels Maintained at the Target Levels of 60-180 pg/mL iPTH Level Uncontrolled cases	2 participants	7 participants

Adverse Events

High Dose Alfacalcidol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Dose Alfacalcidol

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

A study of maintenance therapy after intravenous maxacalcitol for secondary hyperparathyroidism

Department of Nephrology, Kumamoto University Graduate School of Medical Sciences

Phone: +81-96-373-5164

Email: m-adachi@gpo.kumamoto-u.ac.jp

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place