Trial · NCT00616902
The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5
NCT00616902, Phase 3, Terminated, Abbott; results first posted 2010-08-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5. Trials, record NCT00616902. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00616902
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5
- NCT number
- NCT00616902
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 12 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Chronic Kidney Disease (CKD) Stage 5, Hypertrophy, Left Ventricular
- Interventions
- paricalcitol injection 4 mcg/mL, Placebo Injection 4 mcg/mL
- First posted
- 2008-02-15
- Last updated
- 2012-01-20
- Other registries' IDs
- eudract:2007-005092-33
- Results first posted
- 2010-08-04
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI) | Baseline, 24 Weeks, and 48 Weeks/Early Termination | 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. |
| Secondary | Change From Baseline in the Echocardiographic Assessment of Diastolic Function Assessed by Evaluating Changes in Diastolic Mitral Annular Relaxation Velocity (E') Over 48 Weeks. | Baseline, 24 Weeks, and 48 Weeks/Early Termination | Mitral Annular relaxation velocity is a measure of diastolic heart function. |
| Secondary | Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Isovolumetric Relaxation Time (IVRT) Over 48 Weeks. | Baseline, 24 Weeks, and 48 Weeks/Early Termination | Isovolumetric relaxation time is a measure of diastolic heart function. |
| Secondary | 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. | Baseline, Week 24, and Week 48/Early Termination | The ratio of peak E-wave velocity to lateral e-wave velocity is a measure of diastolic heart function. |
| Secondary | Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function E-wave Deceleration Time (DT) Over 48 Weeks | Baseline, 24 Weeks, and 48 Weeks/Early Termination | E-wave deceleration time is a measure of diastolic heart function. |
| Secondary | Change From Baseline in Biological Marker Triiodothyronine (T3). | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) | 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. |
| Secondary | Change From Baseline in Biological Marker Plasma Troponin-T Over 48 Weeks | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) | 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. |
| Secondary | Change From Baseline in Biological Marker Plasma Interleukin-6 (IL-6) Over 48 Weeks | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) | 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. |
| Secondary | Change From Baseline in Biological Marker Plasma High Sensitivity C-reactive Protein (hsCRP) Over 48 Weeks | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) | 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. |
| Secondary | Change From Baseline in Biological Marker Plasma B-Type Natriuretic Peptide (BNP) | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Change From Baseline in the Echocardiographic Assessment of Diastolic Function Assessed by Evaluating Changes in Diastolic Mitral Annular Relaxation Velocity (E') Over 48 Weeks. | Baseline, 24 Weeks, and 48 Weeks/Early Termination | 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. | cm/sec | MEAN |
| PRIMARY | Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI) | Baseline, 24 Weeks, and 48 Weeks/Early Termination | 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. | g/m2.7 | MEAN |
| SECONDARY | Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Isovolumetric Relaxation Time (IVRT) Over 48 Weeks. | Baseline, 24 Weeks, and 48 Weeks/Early Termination | 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. | sec | MEAN |
| SECONDARY | 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. | Baseline, Week 24, and Week 48/Early Termination | 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. | cm/sec | MEAN |
| SECONDARY | Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function E-wave Deceleration Time (DT) Over 48 Weeks | Baseline, 24 Weeks, and 48 Weeks/Early Termination | 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. | sec | MEAN |
| SECONDARY | Change From Baseline in Biological Marker Triiodothyronine (T3). | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) | 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. | nmol/L | MEAN |
| SECONDARY | Change From Baseline in Biological Marker Plasma Troponin-T Over 48 Weeks | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) | 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. | mcg/L | MEAN |
| SECONDARY | Change From Baseline in Biological Marker Plasma Interleukin-6 (IL-6) Over 48 Weeks | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) | 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. | cm/sec | MEAN |
| SECONDARY | Change From Baseline in Biological Marker Plasma High Sensitivity C-reactive Protein (hsCRP) Over 48 Weeks | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) | 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. | mg/L | MEAN |
| SECONDARY | Change From Baseline in Biological Marker Plasma B-Type Natriuretic Peptide (BNP) | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) | 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. | ng/L | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Biological Marker Triiodothyronine (T3). | Paricalcitol Injection 4 Mcg/mL | 0.005 | Standard Deviation 0.5455 | nmol/L | |
| Change From Baseline in Biological Marker Triiodothyronine (T3). | Placebo Injection 4 Mcg/mL | -0.152 | Standard Deviation 0.3640 | nmol/L | |
| Change From Baseline in Biological Marker Plasma Troponin-T Over 48 Weeks | Paricalcitol Injection 4 Mcg/mL | -0.014 | Standard Deviation 0.0195 | mcg/L | |
| Change From Baseline in Biological Marker Plasma Troponin-T Over 48 Weeks | Placebo Injection 4 Mcg/mL | -0.007 | Standard Deviation 0.0175 | mcg/L | |
| Change From Baseline in Biological Marker Plasma Interleukin-6 (IL-6) Over 48 Weeks | Paricalcitol Injection 4 Mcg/mL | -0.200 | Standard Deviation 1.0954 | cm/sec | |
| Change From Baseline in Biological Marker Plasma Interleukin-6 (IL-6) Over 48 Weeks | Placebo Injection 4 Mcg/mL | 0.333 | Standard Deviation 3.7771 | cm/sec | |
| Change From Baseline in Biological Marker Plasma High Sensitivity C-reactive Protein (hsCRP) Over 48 Weeks | Paricalcitol Injection 4 Mcg/mL | 1.104 | Standard Deviation 1.9361 | mg/L | |
| Change From Baseline in Biological Marker Plasma High Sensitivity C-reactive Protein (hsCRP) Over 48 Weeks | Placebo Injection 4 Mcg/mL | -0.762 | Standard Deviation 5.0013 | mg/L | |
| Change From Baseline in Biological Marker Plasma B-Type Natriuretic Peptide (BNP) | Paricalcitol Injection 4 Mcg/mL | -134.200 | Standard Deviation 119.6963 | ng/L | |
| Change From Baseline in Biological Marker Plasma B-Type Natriuretic Peptide (BNP) | Placebo Injection 4 Mcg/mL | 572.800 | Standard Deviation 903.6101 | ng/L |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paricalcitol Injection 4 Mcg/mL | 6 | |
| Overall Study | STARTED | Placebo Injection 4 Mcg/mL | 6 | |
| Overall Study | COMPLETED | Paricalcitol Injection 4 Mcg/mL | 0 | |
| Overall Study | COMPLETED | Placebo Injection 4 Mcg/mL | 0 | |
| Overall Study | NOT COMPLETED | Paricalcitol Injection 4 Mcg/mL | 6 | |
| Overall Study | NOT COMPLETED | Placebo Injection 4 Mcg/mL | 6 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chills | General disorders | Paricalcitol Injection 4 Mcg/mL | 1 | 6 | |
| other | Chills | General disorders | Placebo Injection 4 Mcg/mL | 0 | 6 | |
| other | Headache | Nervous system disorders | Paricalcitol Injection 4 Mcg/mL | 1 | 6 | |
| other | Headache | Nervous system disorders | Placebo Injection 4 Mcg/mL | 0 | 6 | |
| other | Upper respiratory tract infection | Infections and infestations | Paricalcitol Injection 4 Mcg/mL | 1 | 6 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo Injection 4 Mcg/mL | 0 | 6 | |
| other | Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Paricalcitol Injection 4 Mcg/mL | 1 | 6 | |
| other | Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Placebo Injection 4 Mcg/mL | 0 | 6 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Paricalcitol Injection 4 Mcg/mL | 1 | 6 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Placebo Injection 4 Mcg/mL | 0 | 6 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paricalcitol Injection 4 Mcg/mL | ||
| Total, all-cause mortality | Placebo Injection 4 Mcg/mL | ||
| Total, other adverse events | Paricalcitol Injection 4 Mcg/mL | 3 | 6 |
| Total, other adverse events | Placebo Injection 4 Mcg/mL | 3 | 6 |
| Total, serious adverse events | Paricalcitol Injection 4 Mcg/mL | 0 | 6 |
| Total, serious adverse events | Placebo Injection 4 Mcg/mL | 0 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 18591942 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Paricalcitol Injection 4 Mcg/mL vs Placebo Injection 4 Mcg/mL: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00616902
GET https://conductscience.org/api/trials/v1/NCT00616902/events?page=2