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The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5 (PRIMO II)

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: NCT00616902
Recruitment Status : Terminated (This study was prematurely terminated due to low enrollment)
First Posted : February 15, 2008
Results First Posted : August 4, 2010
Last Update Posted : January 20, 2012
Sponsor:
Collaborators:
Massachusetts General Hospital
Harvard University
Information provided by (Responsible Party):
Abbott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Chronic Kidney Disease (CKD) Stage 5
Hypertrophy, Left Ventricular
Interventions Drug: paricalcitol injection 4 mcg/mL
Drug: Placebo Injection 4 mcg/mL
Enrollment 12
Recruitment Details A total of 220 participants were to be randomized in a 1:1 ratio to each treatment group to receive paricalcitol injection or placebo at 75 US and ex-US sites. A stratified randomization scheme was used to ensure balance among treatment groups with respect to country, sex, and baseline Renin Angiotensin-Aldosterone System (RAAS) inhibitor use.
Pre-assignment Details The Screening Period consisted of 3 visits and occurred within 6 weeks prior to participant randomization and enrollment into the Treatment Period of the study. For enrollment, all screening labs and echocardiogram requirements had to be met. Also, a technically adequate cardiac MRI had to be obtained for participant to be randomized into study.
Arm/Group Title Paricalcitol Injection 4 Mcg/mL Placebo Injection 4 Mcg/mL
Hide Arm/Group Description Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis. Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Period Title: Overall Study
Started 6 6
Completed 0 0
Not Completed 6 6
Reason Not Completed
Termination of study             6             6
Arm/Group Title Paricalcitol Injection 4 Mcg/mL Placebo Injection 4 Mcg/mL Total
Hide Arm/Group Description Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis. Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis. Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
< 40 years 1 0 1
40 - < 60 years 3 2 5
>= 60 years 2 4 6
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
54.5  (16.01) 58.8  (7.05) 56.7  (12.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
4
  66.7%
3
  50.0%
7
  58.3%
Male
2
  33.3%
3
  50.0%
5
  41.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  33.3%
0
   0.0%
2
  16.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  16.7%
2
  33.3%
3
  25.0%
White
3
  50.0%
4
  66.7%
7
  58.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)
Hide Description

Change from Baseline in left ventricular mass index (LVMI) over 48 weeks measured by cardiac MRI. The effects of paricalcitol injection on progression or regression of left ventricular hypertrophy (LVH) in participants with Stage 5 chronic kidney disease (CKD) on hemodialysis (HD) compared to placebo. Left Ventricular Mass is normalized to the participant's height by the following equation to obtain LVMI: LVM (g) divided by height (m)2.7.

The primary comparison was between the 4 mcg paricalcitol injection and the placebo treatment groups in the change from baseline to Week 48.

Time Frame Baseline, 24 Weeks, and 48 Weeks/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug and the Evaluable population (a subset of ITT population and consists of those participants who have completed Week 24 visit). None of the participants completed 24 or 48 weeks.
Arm/Group Title Paricalcitol Injection 4 Mcg/mL Placebo Injection 4 Mcg/mL
Hide Arm/Group Description:
Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline in the Echocardiographic Assessment of Diastolic Function Assessed by Evaluating Changes in Diastolic Mitral Annular Relaxation Velocity (E') Over 48 Weeks.
Hide Description Mitral Annular relaxation velocity is a measure of diastolic heart function.
Time Frame Baseline, 24 Weeks, and 48 Weeks/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.
Arm/Group Title Paricalcitol Injection 4 Mcg/mL Placebo Injection 4 Mcg/mL
Hide Arm/Group Description:
Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Isovolumetric Relaxation Time (IVRT) Over 48 Weeks.
Hide Description Isovolumetric relaxation time is a measure of diastolic heart function.
Time Frame Baseline, 24 Weeks, and 48 Weeks/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.
Arm/Group Title Paricalcitol Injection 4 Mcg/mL Placebo Injection 4 Mcg/mL
Hide Arm/Group Description:
Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Peak E-wave Velocity to Lateral E-wave Velocity (E/E') Over 48 Weeks.
Hide Description The ratio of peak E-wave velocity to lateral e-wave velocity is a measure of diastolic heart function.
Time Frame Baseline, Week 24, and Week 48/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.
Arm/Group Title Paricalcitol Injection 4 Mcg/mL Placebo Injection 4 Mcg/mL
Hide Arm/Group Description:
Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function E-wave Deceleration Time (DT) Over 48 Weeks
Hide Description E-wave deceleration time is a measure of diastolic heart function.
Time Frame Baseline, 24 Weeks, and 48 Weeks/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.
Arm/Group Title Paricalcitol Injection 4 Mcg/mL Placebo Injection 4 Mcg/mL
Hide Arm/Group Description:
Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change From Baseline in Biological Marker Triiodothyronine (T3).
Hide Description Plasma T3 is a circulating hormone that may have an effect on diastolic heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.
Time Frame Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.
Arm/Group Title Paricalcitol Injection 4 Mcg/mL Placebo Injection 4 Mcg/mL
Hide Arm/Group Description:
Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: nmol/L
0.005  (0.5455) -0.152  (0.3640)
7.Secondary Outcome
Title Change From Baseline in Biological Marker Plasma Troponin-T Over 48 Weeks
Hide Description Plasma troponin-t is a marker of heart damage and and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.
Time Frame Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.
Arm/Group Title Paricalcitol Injection 4 Mcg/mL Placebo Injection 4 Mcg/mL
Hide Arm/Group Description:
Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: mcg/L
-0.014  (0.0195) -0.007  (0.0175)
8.Secondary Outcome
Title Change From Baseline in Biological Marker Plasma Interleukin-6 (IL-6) Over 48 Weeks
Hide Description Plasma IL-6 is a biomarker of inflammation that may have an effect on heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.
Time Frame Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.
Arm/Group Title Paricalcitol Injection 4 Mcg/mL Placebo Injection 4 Mcg/mL
Hide Arm/Group Description:
Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: cm/sec
-0.200  (1.0954) 0.333  (3.7771)
9.Secondary Outcome
Title Change From Baseline in Biological Marker Plasma High Sensitivity C-reactive Protein (hsCRP) Over 48 Weeks
Hide Description Plasma high sensitivity CRP is a biomarker of inflammation that may have an effect on heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.
Time Frame Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.
Arm/Group Title Paricalcitol Injection 4 Mcg/mL Placebo Injection 4 Mcg/mL
Hide Arm/Group Description:
Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: mg/L
1.104  (1.9361) -0.762  (5.0013)
10.Secondary Outcome
Title Change From Baseline in Biological Marker Plasma B-Type Natriuretic Peptide (BNP)
Hide Description Plasma BNP is a product from the heart that becomes elevated with an enlarged heart and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.
Time Frame Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.
Arm/Group Title Paricalcitol Injection 4 Mcg/mL Placebo Injection 4 Mcg/mL
Hide Arm/Group Description:
Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: ng/L
-134.200  (119.6963) 572.800  (903.6101)
Time Frame 48 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paricalcitol Injection 4 Mcg/mL Placebo Injection 4 Mcg/mL
Hide Arm/Group Description Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis. Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
All-Cause Mortality
Paricalcitol Injection 4 Mcg/mL Placebo Injection 4 Mcg/mL
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Paricalcitol Injection 4 Mcg/mL Placebo Injection 4 Mcg/mL
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Paricalcitol Injection 4 Mcg/mL Placebo Injection 4 Mcg/mL
Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   3/6 (50.00%) 
Ear and labyrinth disorders     
Ear pruritus * 1  1/6 (16.67%)  0/6 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/6 (16.67%)  0/6 (0.00%) 
Abdominal discomfort * 1  0/6 (0.00%)  1/6 (16.67%) 
vomiting * 1  0/6 (0.00%)  1/6 (16.67%) 
General disorders     
Chills * 1  1/6 (16.67%)  0/6 (0.00%) 
Infections and infestations     
Upper respiratory tract infection * 1  1/6 (16.67%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders     
musculoskeletal pain * 1  0/6 (0.00%)  1/6 (16.67%) 
Nervous system disorders     
Headache * 1  1/6 (16.67%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Rhinitis allergic * 1  1/6 (16.67%)  0/6 (0.00%) 
Respiratory disorder * 1  0/6 (0.00%)  1/6 (16.67%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  1/6 (16.67%)  0/6 (0.00%) 
Rash papular * 1  1/6 (16.67%)  0/6 (0.00%) 
Rash pruritic * 1  1/6 (16.67%)  0/6 (0.00%) 
Vascular disorders     
Hypertension * 1  0/6 (0.00%)  1/6 (16.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
This study was prematurely terminated due to low enrollment. Only 12 subjects were randomized at 10 investigative sites with none of the subjects completing the study.
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: NCT00616902    
Other Study ID Numbers: M10-221
2007-005092-33 ( EudraCT Number )
First Submitted: February 5, 2008
First Posted: February 15, 2008
Results First Submitted: May 21, 2010
Results First Posted: August 4, 2010
Last Update Posted: January 20, 2012