Trial · NCT00497146

The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4

NCT00497146, Phase 3, Completed, AbbVie (prior sponsor, Abbott); results first posted 2011-12-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4. Trials, record NCT00497146. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00497146

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4
NCT number: NCT00497146
Status: Completed
Phases: Phase 3
Enrollment: 227 participants, actual
Lead sponsor: AbbVie (prior sponsor, Abbott)
Conditions: Chronic Kidney Disease, Left Ventricular Hypertrophy
Interventions: paricalcitol, placebo
First posted: 2007-07-06
Last updated: 2013-03-12
Other registries' IDs: eudract:2007-001689-34
Results first posted: 2011-12-23

Source ClinicalTrials.gov

Registered outcomes17

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 to 48 weeks	The Central Cardiac MRI Core Laboratory (CCL) interpreted and analyzed all cardiac MRI data. Left Ventricular Mass (LVM) was normalized to the participant's height by the following equation to obtain LVMI: LVM (grams) divided by height (meters)\^2.7.
Secondary	Change in Diastolic Mitral Annular Relaxation Velocity (E')	Baseline to 48 weeks	Diastolic mitral annular relaxation velocity (lateral E wave velocity; E') is a measure of diastolic function.
Secondary	Change in Ratio of Peak E Wave Velocity to Lateral E Wave Velocity (E/E')	Baseline to 48 weeks	The ratio of peak E wave velocity to lateral E wave velocity (E/E') is a measure of diastolic function.
Secondary	Change in E-wave Deceleration Time (DT)	Baseline to 48 weeks	E-wave deceleration time (DT) is a measure of diastolic function.
Secondary	Change in Isovolumetric Relaxation Time (IVRT)	Baseline to 48 weeks	Isovolumetric relaxation time (IVRT) is a measure of diastolic function.
Secondary	Change in Left Atrial Volume	Baseline to 48 weeks	Left atrial volume is a measure of diastolic function.
Secondary	Change in Plasma Triiodothyronine (T3)	Baseline to 48 weeks	Plasma triiodothyronine (T3) is a biological and inflammatory marker.
Secondary	Change in Interleukin-6 (IL-6)	Baseline to 48 weeks	Interleukin-6 (IL-6) is a biological and inflammatory marker.
Secondary	Change in Troponin-T	Baseline to 48 weeks	Troponin-T is a biological and inflammatory marker.
Secondary	Change in B-type Natriuretic Peptide (BNP)	Baseline to 48 weeks	B-type natriuretic peptide (BNP) is a biological and inflammatory marker.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)	Baseline to 48 weeks	The analysis was based on the intent-to-treat (ITT) population, defined as all randomized participants who took at least one dose of study drug, with available data.	grams/meter^2.7	LEAST_SQUARES_MEAN
SECONDARY	Change in Diastolic Mitral Annular Relaxation Velocity (E')	Baseline to 48 weeks	The intent-to-treat (ITT) population, participants with available data.	centimeters/second	LEAST_SQUARES_MEAN
SECONDARY	Change in Ratio of Peak E Wave Velocity to Lateral E Wave Velocity (E/E')	Baseline to 48 weeks	The intent-to-treat (ITT) population, participants with available data.	ratio	LEAST_SQUARES_MEAN
SECONDARY	Change in E-wave Deceleration Time (DT)	Baseline to 48 weeks	The intent-to-treat (ITT) population, participants with available data.	seconds	LEAST_SQUARES_MEAN
SECONDARY	Change in Isovolumetric Relaxation Time (IVRT)	Baseline to 48 weeks	The intent-to-treat (ITT) population, participants with available data.	seconds	LEAST_SQUARES_MEAN
SECONDARY	Change in Left Atrial Volume	Baseline to 48 weeks	The intent-to-treat (ITT) population, participants with available data.	milliliters	LEAST_SQUARES_MEAN
SECONDARY	Change in Plasma Triiodothyronine (T3)	Baseline to 48 weeks	The intent-to-treat (ITT) population, participants with available data.	nanomoles/liter	LEAST_SQUARES_MEAN
SECONDARY	Change in Interleukin-6 (IL-6)	Baseline to 48 weeks	The intent-to-treat (ITT) population, participants with available data.	nanograms/liter	LEAST_SQUARES_MEAN
SECONDARY	Change in Troponin-T	Baseline to 48 weeks	The intent-to-treat (ITT) population, participants with available data.	micrograms/liter	LEAST_SQUARES_MEAN
SECONDARY	Change in B-type Natriuretic Peptide (BNP)	Baseline to 48 weeks	The intent-to-treat (ITT) population, participants with available data.	log nanograms/liter	LEAST_SQUARES_MEAN

1 to 10 of 17Source ClinicalTrials.gov

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Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)	Paricalcitol	0.34	Standard Error 0.248	grams/meter^2.7
Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)	Placebo	-0.07	Standard Error 0.246	grams/meter^2.7
Change in Diastolic Mitral Annular Relaxation Velocity (E')	Paricalcitol	-0.01	Standard Error 0.314	centimeters/second
Change in Diastolic Mitral Annular Relaxation Velocity (E')	Placebo	-0.30	Standard Error 0.323	centimeters/second
Change in Ratio of Peak E Wave Velocity to Lateral E Wave Velocity (E/E')	Paricalcitol	0.16	Standard Error 0.580	ratio
Change in Ratio of Peak E Wave Velocity to Lateral E Wave Velocity (E/E')	Placebo	-0.33	Standard Error 0.601	ratio
Change in E-wave Deceleration Time (DT)	Paricalcitol	0.01	Standard Error 0.004	seconds
Change in E-wave Deceleration Time (DT)	Placebo	-0.00	Standard Error 0.005	seconds
Change in Isovolumetric Relaxation Time (IVRT)	Paricalcitol	0.00	Standard Error 0.002	seconds
Change in Isovolumetric Relaxation Time (IVRT)	Placebo	-0.00	Standard Error 0.002	seconds

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period	STARTED	Paricalcitol	115
Treatment Period	STARTED	Placebo	112
Treatment Period	COMPLETED	Paricalcitol	88
Treatment Period	COMPLETED	Placebo	91
Treatment Period	NOT COMPLETED	Paricalcitol	27
Treatment Period	NOT COMPLETED	Placebo	21
Long-term Follow-up Period	STARTED	Paricalcitol	65
Long-term Follow-up Period	STARTED	Placebo	72
Long-term Follow-up Period	COMPLETED	Paricalcitol	50
Long-term Follow-up Period	COMPLETED	Placebo	66

1 to 10 of 12Source ClinicalTrials.gov

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Adverse events616

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
other	Anaemia	Blood and lymphatic system disorders	Paricalcitol: Treatment Period	7	115
other	Anaemia	Blood and lymphatic system disorders	Placebo: Treatment Period	6	112
other	Anaemia	Blood and lymphatic system disorders	Paricalcitol: Long-term Follow-up	1	65
other	Anaemia	Blood and lymphatic system disorders	Placebo: Long-term Follow-up	0	72
other	Bradycardia	Cardiac disorders	Paricalcitol: Treatment Period	0	115
other	Bradycardia	Cardiac disorders	Placebo: Treatment Period	4	112
other	Bradycardia	Cardiac disorders	Paricalcitol: Long-term Follow-up	0	65
other	Bradycardia	Cardiac disorders	Placebo: Long-term Follow-up	0	72
other	Vertigo	Ear and labyrinth disorders	Paricalcitol: Treatment Period	3	115
other	Vertigo	Ear and labyrinth disorders	Placebo: Treatment Period	4	112

1 to 10 of 616Source ClinicalTrials.gov

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Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Paricalcitol: Treatment Period
Total, all-cause mortality	Placebo: Treatment Period
Total, all-cause mortality	Paricalcitol: Long-term Follow-up
Total, all-cause mortality	Placebo: Long-term Follow-up
Total, other adverse events	Paricalcitol: Treatment Period	75	115
Total, other adverse events	Placebo: Treatment Period	68	112
Total, other adverse events	Paricalcitol: Long-term Follow-up	4	65
Total, other adverse events	Placebo: Long-term Follow-up	8	72
Total, serious adverse events	Paricalcitol: Treatment Period	20	115
Total, serious adverse events	Placebo: Treatment Period	20	112

1 to 10 of 12Source ClinicalTrials.gov

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Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
18591942	DERIVED	PubMed
21242674	DERIVED	PubMed
22337679	DERIVED	PubMed
23194491	DERIVED	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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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