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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00664430
Recruitment Status : Terminated (Low enrollment rate)
First Posted : April 23, 2008
Results First Posted : August 18, 2010
Last Update Posted : January 20, 2012
Sponsor:
Collaborator:
Statistika Consultoria Ltda
Information provided by (Responsible Party):
Abbott

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Secondary Hyperparathyroidism
Dialysis
Interventions Drug: Calcitriol
Drug: Paricalcitol
Enrollment 13
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Calcitriol Challenge Followed by Paricalcitol
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 13
Completed 0 [1]
Not Completed 13
[1]
Study terminated early due to low enrollment rate.
Arm/Group Title Calcitriol Challenge Followed by Paricalcitol
Hide Arm/Group Description 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 Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
  92.3%
>=65 years
1
   7.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
6
  46.2%
Male
7
  53.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 13 participants
13
1.Primary Outcome
Title Proportion of Participants With a 50% Reduction in Parathyroid Hormone (PTH) Levels Relative to Visit 4 Values
Hide Description 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.
Time Frame Up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Calcitriol Challenge Followed by Paricalcitol
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Changes in Bone Remodeling Markers Over Time
Hide Description Deoxypyridinoline and bone-specific alkaline phosphatase levels were to be measured every 3 months and changes over time analyzed using descriptive statistics.
Time Frame Every 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Calcitriol Challenge Followed by Paricalcitol
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description 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.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calcitriol Challenge Followed by Paricalcitol
Hide Arm/Group Description:
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 Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: Participants
3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Calcitriol Challenge Followed by Paricalcitol
Hide Arm/Group Description 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.
All-Cause Mortality
Calcitriol Challenge Followed by Paricalcitol
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Calcitriol Challenge Followed by Paricalcitol
Affected / at Risk (%) # Events
Total   0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Calcitriol Challenge Followed by Paricalcitol
Affected / at Risk (%) # Events
Total   3/13 (23.08%)    
Cardiac disorders   
Tachycardia  1  1/13 (7.69%)  1
Gastrointestinal disorders   
Nausea  1  1/13 (7.69%)  3
Transitory dyspepsia  1  1/13 (7.69%)  1
Nervous system disorders   
Headache  1  2/13 (15.38%)  5
Paresthesia of right upper limbs  1  1/13 (7.69%)  1
Vascular disorders   
Hypertension  1  1/13 (7.69%)  1
Hypotension  1  1/13 (7.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART
Early termination leading to no efficacy evaluation. All adverse events occurred during calcitriol challenge phase.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
Layout table for additonal information
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00664430     History of Changes
Other Study ID Numbers: W10-131
First Submitted: April 21, 2008
First Posted: April 23, 2008
Results First Submitted: June 3, 2010
Results First Posted: August 18, 2010
Last Update Posted: January 20, 2012