Trial Outcomes & Findings for Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol (NCT NCT01725113)

NCT ID: NCT01725113

Last Updated: 2023-11-07

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 16 participants
• Primary outcome timeframe: Up to Month 6
• Results posted on: 2023-11-07

Participant Flow

Of the 16 enrolled participants, 3 were removed due to screen failure and 1 patient experienced death before the start of study.

Participant milestones

Measure	Calcitriol, Then Paricalcitol Patients randomized to an active vitamin D treatment protocol based on IV calcitriol. After 14 weeks, patients cross-over to an active vitamin D protocol based on IV paricalcitol for 14 weeks. Calcitriol: 3 times weekly Paricalcitol: 3 times weekly	Paricalcitol, Then Calcitriol Patients randomized to an active vitamin D treatment protocol based on IV paricalcitol. After 14 weeks, patients cross-over to an active vitamin D protocol based on IV calcitriol for 14 weeks. Calcitriol: 3 times weekly Paricalcitol: 3 times weekly
Overall Study STARTED	6	6
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Calcitriol, Then Paricalcitol Patients randomized to an active vitamin D treatment protocol based on IV calcitriol. After 14 weeks, patients cross-over to an active vitamin D protocol based on IV paricalcitol for 14 weeks. Calcitriol: 3 times weekly Paricalcitol: 3 times weekly	Paricalcitol, Then Calcitriol Patients randomized to an active vitamin D treatment protocol based on IV paricalcitol. After 14 weeks, patients cross-over to an active vitamin D protocol based on IV calcitriol for 14 weeks. Calcitriol: 3 times weekly Paricalcitol: 3 times weekly
Overall Study Kidney Transplant	1	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol

Baseline characteristics by cohort

Measure	Total Participants Who Completed Trial n=9 Participants Participants (n=9) who completed the trial.
Age, Continuous	74.11 years STANDARD_DEVIATION 5.57 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Month 6

Outcome measures

Measure	Calcitriol n=9 Participants Comprises participants who received Calcitriol either in the first 14 weeks or last 14 weeks of the treatment period.
Calcium Levels at Month 3 Post Calcitriol Treatment Initiation	8.78 mg/dl Standard Deviation 0.332

PRIMARY outcome

Timeframe: Up to Month 6

Outcome measures

Measure	Calcitriol n=9 Participants Comprises participants who received Calcitriol either in the first 14 weeks or last 14 weeks of the treatment period.
Calcium Levels at Month 3 Post Paricalcitol Treatment Initiation	8.6 mg/dl Standard Deviation 0.3

SECONDARY outcome

Timeframe: Up to Month 6

Outcome measures

Measure	Calcitriol n=9 Participants Comprises participants who received Calcitriol either in the first 14 weeks or last 14 weeks of the treatment period.
PTH Levels at Month 3 Post Calcitriol Treatment Initiation	309.58 pg/dl Standard Deviation 183.33

SECONDARY outcome

Timeframe: Up to Month 6

Outcome measures

Measure	Calcitriol n=9 Participants Comprises participants who received Calcitriol either in the first 14 weeks or last 14 weeks of the treatment period.
PTH Levels at Month 3 Post Paricalcitol Treatment Initiation	332.83 pg/dl Standard Deviation 146.9

SECONDARY outcome

Timeframe: Up to Month 6

Outcome measures

Measure	Calcitriol n=9 Participants Comprises participants who received Calcitriol either in the first 14 weeks or last 14 weeks of the treatment period.
Phosphorus Levels at Month 3 Post Calcitriol Initiation	4.09 mg/dl Standard Deviation 0.71

SECONDARY outcome

Timeframe: Up to Month 6

Outcome measures

Measure	Calcitriol n=9 Participants Comprises participants who received Calcitriol either in the first 14 weeks or last 14 weeks of the treatment period.
Phosphorus Levels at Month 3 Post Paricalcitol Initiation	4.45 mg/dl Standard Deviation 1.18

SECONDARY outcome

Timeframe: Up to Month 6

Outcome measures

Measure	Calcitriol n=9 Participants Comprises participants who received Calcitriol either in the first 14 weeks or last 14 weeks of the treatment period.
Amount of Active Vitamin D Analog Used Through Month 3 Post Calcitriol Initiation	36.9 mcg Standard Deviation 34.18

SECONDARY outcome

Timeframe: Up to Month 6

Outcome measures

Measure	Calcitriol n=9 Participants Comprises participants who received Calcitriol either in the first 14 weeks or last 14 weeks of the treatment period.
Amount of Active Vitamin D Analog Used Through Month 3 Post Paricalcitol Initiation	134.6 mcg Standard Deviation 87.35

Adverse Events

Calcitriol

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Paricalcitol

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Calcitriol n=9 participants at risk Comprises participants who received Calcitriol either in the first 14 weeks or last 14 weeks of the treatment period.	Paricalcitol n=9 participants at risk Comprises participants who received Paricalcitol either in the first 14 weeks or last 14 weeks of the treatment period.
Renal and urinary disorders Hematuria	11.1% 1/9 • 6 months	11.1% 1/9 • 6 months
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/9 • 6 months	11.1% 1/9 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Candace Grant

NYU Langone Health

Phone: 5166632171

Email: Candace.Grant@nyulangone.org

Results disclosure agreements

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