Trial Outcomes & Findings for Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects (NCT NCT00664430)

Results Overview

This outcome was measured at Visit 15, which could occur at different timepoints from study start, depending on the duration of each study period for each participant, relative to values on Visit 4. For participants who did not perform visit 4, the reduction of the PTH levels were to be assessed relative to visit 5 values.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

13 participants

Primary outcome timeframe

Up to Week 24

Results posted on

2012-01-20

Participant Flow

After Screening, participants entered an 8-week controlled calcitriol period. Participants whose parathyroid hormone (PTH) levels decreased after 8 weeks (i.e., participants who were not resistant to calcitriol) were discontinued from the study.

Participant milestones

Participant milestones
Measure	Calcitriol Challenge Followed by Paricalcitol To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
Overall Study STARTED	13
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Calcitriol Challenge Followed by Paricalcitol n=13 Participants To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment Brazil	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 24

Population: No efficacy analysis was performed in this study. At the time the study was stopped, 3 participants were receiving paricalcitol, but none of them had reached the time point for the primary analysis.

This outcome was measured at Visit 15, which could occur at different timepoints from study start, depending on the duration of each study period for each participant, relative to values on Visit 4. For participants who did not perform visit 4, the reduction of the PTH levels were to be assessed relative to visit 5 values.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 3 months

Population: No efficacy analysis was performed in this study. At the time the study was stopped, 3 participants were receiving paricalcitol, but none of them had reached the time point for the secondary analysis.

Deoxypyridinoline and bone-specific alkaline phosphatase levels were to be measured every 3 months and changes over time analyzed using descriptive statistics.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 year

The occurrence of adverse events was considered a secondary endpoint in this study. For details on adverse events that occurred prior to study termination, refer to the safety section below.

Outcome measures

Outcome measures
Measure	Calcitriol Challenge Followed by Paricalcitol n=13 Participants To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
Number of Participants With Adverse Events	3 Participants

Adverse Events

Calcitriol Challenge Followed by Paricalcitol

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Calcitriol Challenge Followed by Paricalcitol n=13 participants at risk To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
Nervous system disorders Headache	15.4% 2/13 • Number of events 5
Cardiac disorders Tachycardia	7.7% 1/13 • Number of events 1
Vascular disorders Hypertension	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Nausea	7.7% 1/13 • Number of events 3
Vascular disorders Hypotension	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Transitory dyspepsia	7.7% 1/13 • Number of events 1
Nervous system disorders Paresthesia of right upper limbs	7.7% 1/13 • Number of events 1

Additional Information

Global Medical Services

Abbott

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER