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Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT01071070
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : January 26, 2012
Last Update Posted : January 26, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Chronic Kidney Disease
Intervention Drug: paricalcitol
Enrollment 216
Recruitment Details Participants were enrolled in the study at investigative sites in China. Recruitment began in October 2009 and ended in July 2010. The study population consisted of participants with Stage 5 chronic kidney disease who were receiving hemodialysis.
Pre-assignment Details If subjects were receiving vitamin D receptor (VDR) activators, they participated in a Washout Phase for 2 weeks prior to entering into the Screening Phase in order to wash out any VDR activators and their potential hysteresis or carryover effects.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL). Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
Period Title: Overall Study
Started 108 108
Completed 104 105
Not Completed 4 3
Reason Not Completed
Adverse Event             0             3
Withdrawal by Subject             1             0
Missed 3 consecutive doses of study drug             2             0
Hypercalcemia             1             0
Arm/Group Title Group 1 Group 2 Total
Hide Arm/Group Description Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL). Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg) Total of all reporting groups
Overall Number of Baseline Participants 108 108 216
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 108 participants 216 participants
50.5  (13.55) 50.8  (12.67) 50.6  (13.09)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 108 participants 108 participants 216 participants
< 65 years 91 93 184
>=65 years 17 15 32
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 108 participants 216 participants
Female
41
  38.0%
36
  33.3%
77
  35.6%
Male
67
  62.0%
72
  66.7%
139
  64.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 108 participants 108 participants 216 participants
108 108 216
1.Primary Outcome
Title The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels
Hide Description The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values
Time Frame Baseline to 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the per-protocol population, which consisted of all randomized participants who completed at least 6 weeks of treatment and met the conditions that defined the per-protocol population.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
Overall Number of Participants Analyzed 105 102
Measure Type: Number
Unit of Measure: participants
Yes 93 57
No 12 45
2.Secondary Outcome
Title The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL
Hide Description The number of subjects with (Yes) or without (No) final intact parathyroid hormone (iPTH) values between 150 and 300 pg/mL
Time Frame Baseline to 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
Overall Number of Participants Analyzed 108 108
Measure Type: Number
Unit of Measure: participants
Yes 19 21
No 89 87
3.Secondary Outcome
Title The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value
Hide Description [Not Specified]
Time Frame Baseline to 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
Overall Number of Participants Analyzed 108 108
Mean (Standard Error)
Unit of Measure: pg/mL
-342.57  (43.82) -191.53  (43.82)
4.Secondary Outcome
Title The Change From Baseline to the Final Observation in Calcium
Hide Description [Not Specified]
Time Frame Baseline to 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
Overall Number of Participants Analyzed 108 108
Mean (Standard Error)
Unit of Measure: mg/dL
0.64  (0.06) 0.59  (0.06)
5.Secondary Outcome
Title The Change From Baseline to the Final Observation in Calcium-phosphorus Product
Hide Description [Not Specified]
Time Frame Baseline to 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
Overall Number of Participants Analyzed 108 108
Mean (Standard Error)
Unit of Measure: mg^2/dL^2
7.53  (1.47) 8.15  (1.47)
6.Secondary Outcome
Title The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure
Hide Description [Not Specified]
Time Frame Baseline to 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
Overall Number of Participants Analyzed 108 108
Mean (Standard Deviation)
Unit of Measure: mm Hg
-1.47  (19.76) -1.75  (21.03)
7.Secondary Outcome
Title The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure
Hide Description [Not Specified]
Time Frame Baseline to 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
Overall Number of Participants Analyzed 108 108
Mean (Standard Deviation)
Unit of Measure: mm Hg
-1.47  (11.31) -0.32  (13.68)
8.Secondary Outcome
Title The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate
Hide Description [Not Specified]
Time Frame Baseline to 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
Overall Number of Participants Analyzed 108 108
Mean (Standard Deviation)
Unit of Measure: beats per minute
0.51  (9.48) -0.89  (11.38)
9.Secondary Outcome
Title The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)
Hide Description The number of subjects with (Yes) or without (No) two consecutive calcium measurements greater than 11.0 mg/dL (2.75 mmol/L)
Time Frame Baseline to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
Overall Number of Participants Analyzed 108 108
Measure Type: Number
Unit of Measure: participants
Yes 1 0
No 107 108
Time Frame From the time of study drug administration until 30 days following discontinuation of study drug administration.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL). Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
All-Cause Mortality
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   3/108 (2.78%) 
Cardiac disorders     
Myocardial ischaemia  0/108 (0.00%)  1/108 (0.93%) 
Ear and labyrinth disorders     
Deafness neurosensory  0/108 (0.00%)  1/108 (0.93%) 
Nervous system disorders     
Cerebral haemorrhage  0/108 (0.00%)  1/108 (0.93%) 
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   29/108 (26.85%)   19/108 (17.59%) 
Blood and lymphatic system disorders     
Nephrogenic anaemia  0/108 (0.00%)  1/108 (0.93%) 
Cardiac disorders     
Palpitations  1/108 (0.93%)  1/108 (0.93%) 
Eye disorders     
Eyelid oedema  0/108 (0.00%)  1/108 (0.93%) 
Gastrointestinal disorders     
Abdominal discomfort  0/108 (0.00%)  1/108 (0.93%) 
Abdominal rigidity  1/108 (0.93%)  0/108 (0.00%) 
Diarrhoea  2/108 (1.85%)  2/108 (1.85%) 
Enteritis  1/108 (0.93%)  0/108 (0.00%) 
Gingivitis  1/108 (0.93%)  0/108 (0.00%) 
Haemorrhoidal haemorrhage  0/108 (0.00%)  1/108 (0.93%) 
Lip oedema  0/108 (0.00%)  1/108 (0.93%) 
Vomiting  1/108 (0.93%)  0/108 (0.00%) 
General disorders     
Chest discomfort  1/108 (0.93%)  0/108 (0.00%) 
Chest pain  1/108 (0.93%)  0/108 (0.00%) 
Oedema peripheral  0/108 (0.00%)  1/108 (0.93%) 
Pyrexia  1/108 (0.93%)  2/108 (1.85%) 
Infections and infestations     
Pharyngitis  1/108 (0.93%)  0/108 (0.00%) 
Respiratory tract infection  1/108 (0.93%)  0/108 (0.00%) 
Upper respiratory tract infection  8/108 (7.41%)  6/108 (5.56%) 
Injury, poisoning and procedural complications     
Fibula fracture  1/108 (0.93%)  0/108 (0.00%) 
Procedural hypotension  2/108 (1.85%)  0/108 (0.00%) 
Investigations     
Alanine aminotransferase increased  1/108 (0.93%)  0/108 (0.00%) 
Aspartate aminotransferase increased  1/108 (0.93%)  0/108 (0.00%) 
Metabolism and nutrition disorders     
Hypercalcaemia  2/108 (1.85%)  0/108 (0.00%) 
Hyperkalaemia  1/108 (0.93%)  0/108 (0.00%) 
Hyperphosphataemia  0/108 (0.00%)  1/108 (0.93%) 
Hypoglycaemia  2/108 (1.85%)  1/108 (0.93%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1/108 (0.93%)  0/108 (0.00%) 
Back pain  0/108 (0.00%)  1/108 (0.93%) 
Muscle spasms  1/108 (0.93%)  1/108 (0.93%) 
Myalgia  0/108 (0.00%)  1/108 (0.93%) 
Tenosynovitis  1/108 (0.93%)  0/108 (0.00%) 
Nervous system disorders     
Cerebral haemorrhage  1/108 (0.93%)  0/108 (0.00%) 
Dizziness  1/108 (0.93%)  2/108 (1.85%) 
Headache  1/108 (0.93%)  1/108 (0.93%) 
Psychiatric disorders     
Insomnia  1/108 (0.93%)  2/108 (1.85%) 
Renal and urinary disorders     
Haematuria  0/108 (0.00%)  1/108 (0.93%) 
Respiratory, thoracic and mediastinal disorders     
Cough  2/108 (1.85%)  0/108 (0.00%) 
Dyspnoea  0/108 (0.00%)  1/108 (0.93%) 
Oropharyngeal pain  1/108 (0.93%)  0/108 (0.00%) 
Upper airway obstruction  1/108 (0.93%)  0/108 (0.00%) 
Skin and subcutaneous tissue disorders     
Drug eruption  1/108 (0.93%)  0/108 (0.00%) 
Pruritus  3/108 (2.78%)  0/108 (0.00%) 
Rash  0/108 (0.00%)  1/108 (0.93%) 
Vascular disorders     
Hypertension  3/108 (2.78%)  1/108 (0.93%) 
Hypotension  1/108 (0.93%)  0/108 (0.00%) 
1
Term from vocabulary, MedDRA 13.0
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
Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01071070     History of Changes
Other Study ID Numbers: M06-823
First Submitted: November 25, 2009
First Posted: February 19, 2010
Results First Submitted: November 7, 2011
Results First Posted: January 26, 2012
Last Update Posted: January 26, 2012