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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001689-34 | EudraCT Number |
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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
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To evaluate the effects of paricalcitol capsules on cardiac structure and function over 48 weeks in patients with Stage 3/4 chronic kidney disease (CKD) who had left ventricular hypertrophy (LVH).
Patients who met the inclusion criteria and did not meet any of the exclusion criteria were randomized in a 1:1 ratio to each treatment group to receive paricalcitol capsules or placebo. A stratified randomization scheme was used to ensure balance among treatment groups with respect to country, gender, and baseline renin angiotensin-aldosterone system (RAAS) inhibitor use (yes/no).
Participants who completed the 48-Week Treatment Period could continue on in the ongoing Long-term Follow-up Period that was to last 18 months, with study visits at 6 months, 12 months and 18 months post Treatment Week 48 Visit. Participants did not receive study drug, nor were they to have undergone echocardiogram/MRI procedures during the Long-term Follow-up Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paricalcitol | Experimental | Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period. |
|
| Placebo | Placebo Comparator | Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paricalcitol | Drug | 2 µg capsule |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI) | 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. | Baseline to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diastolic Mitral Annular Relaxation Velocity (E') | Diastolic mitral annular relaxation velocity (lateral E wave velocity; E') is a measure of diastolic function. | Baseline to 48 weeks |
| Change in Ratio of Peak E Wave Velocity to Lateral E Wave Velocity (E/E') |
Not provided
Inclusion Criteria:
Estimated glomerular filtration rate (GFR) between 15-60 mL/min/1.73 m^2
Serum intact parathyroid hormone (iPTH) value between 50-300 pg/mL
Corrected serum calcium level 8.0-10.0 mg/dL (2.0-2.5 mmol/L)
Phosphorous level less than or equal to 5.2 mg/dL (1.68 mmol/L)
Serum albumin greater than or equal to 3.0 g/dL (30 g/L)
Echocardiogram results of:
If the subject is receiving renin-angiotensin-aldosterone system (RAAS) inhibitors the dose must have been stable for greater than one month prior to the Screening Period. However, the subject may have switched to different brands but at equivalent doses as determined by the study physician during the month prior to the Screening Period.
Subject must have a technically adequate baseline cardiac magnetic resonance imaging (MRI).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Eldred, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 8062 | Phoenix | Arizona | 85012 | United States | ||
| Site Reference ID/Investigator# 8867 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23194491 | Derived | Tamez H, Zoccali C, Packham D, Wenger J, Bhan I, Appelbaum E, Pritchett Y, Chang Y, Agarwal R, Wanner C, Lloyd-Jones D, Cannata J, Thompson BT, Andress D, Zhang W, Singh B, Zehnder D, Pachika A, Manning WJ, Shah A, Solomon SD, Thadhani R. Vitamin D reduces left atrial volume in patients with left ventricular hypertrophy and chronic kidney disease. Am Heart J. 2012 Dec;164(6):902-9.e2. doi: 10.1016/j.ahj.2012.09.018. Epub 2012 Oct 29. | |
| 22337679 |
| Label | URL |
|---|---|
| Related Info | View source |
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Not provided
Participants were enrolled in the study at US and ex-US investigative sites. Recruitment began in March 2008 and ended in December 2009. The study population consisted of participants with Stage 3/4 chronic kidney disease who had a diagnosis of left ventricular hypertrophy confirmed by echocardiogram and cardiac magnetic resonance imaging.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paricalcitol | Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
Not provided
Not provided
Not provided
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| placebo | Drug | placebo capsule |
|
The ratio of peak E wave velocity to lateral E wave velocity (E/E') is a measure of diastolic function. |
| Baseline to 48 weeks |
| Change in E-wave Deceleration Time (DT) | E-wave deceleration time (DT) is a measure of diastolic function. | Baseline to 48 weeks |
| Change in Isovolumetric Relaxation Time (IVRT) | Isovolumetric relaxation time (IVRT) is a measure of diastolic function. | Baseline to 48 weeks |
| Change in Left Atrial Volume | Left atrial volume is a measure of diastolic function. | Baseline to 48 weeks |
| Change in Plasma Triiodothyronine (T3) | Plasma triiodothyronine (T3) is a biological and inflammatory marker. | Baseline to 48 weeks |
| Change in Interleukin-6 (IL-6) | Interleukin-6 (IL-6) is a biological and inflammatory marker. | Baseline to 48 weeks |
| Change in Troponin-T | Troponin-T is a biological and inflammatory marker. | Baseline to 48 weeks |
| Change in B-type Natriuretic Peptide (BNP) | B-type natriuretic peptide (BNP) is a biological and inflammatory marker. | Baseline to 48 weeks |
| Change in High Sensitivity C-reactive Protein (hsCRP) | High sensitivity C-reactive protein (hsCRP) is a biological and inflammatory marker. | Baseline to 48 weeks |
| Change in Progression of Thoraco-abdominal Aortic Plaque Volume | Change from baseline to Week 48 in thoraco-abdominal aortic plaque volume. | Baseline to 48 weeks |
| Change in Progression of Thoraco-abdominal Aortic Wall Volume | Change from baseline to Week 48 in thoraco-abdominal aortic wall volume | Baseline to 48 weeks |
| Change in Progression of Aortic Compliance | Change from baseline to Week 48 in aortic compliance. | Baseline to 48 weeks |
| Change in Progression of Left Ventricular End-systolic Volume Index | Change from baseline to Week 48 in left ventricular end-systolic volume index. | Baseline to 48 weeks |
| Change in Progression of Left Ventricular End-diastolic Volume Index | Change from baseline to Week 48 in left ventricular end-diastolic volume index. | Baseline to 48 weeks |
| Change in Progression of Left Ventricular Ejection Fraction | Change from baseline to Week 48 in left ventricular ejection fraction. | Baseline to 48 weeks |
| Tempe |
| Arizona |
| 85284 |
| United States |
| Site Reference ID/Investigator# 8864 | San Diego | California | 92123 | United States |
| Site Reference ID/Investigator# 7257 | San Dimas | California | 91773 | United States |
| Site Reference ID/Investigator# 7727 | Denver | Colorado | 80230 | United States |
| Site Reference ID/Investigator# 8861 | Miami | Florida | 33136 | United States |
| Site Reference ID/Investigator# 7260 | Orlando | Florida | 32806 | United States |
| Site Reference ID/Investigator# 7725 | Tampa | Florida | 33603 | United States |
| Site Reference ID/Investigator# 7824 | Tampa | Florida | 33614 | United States |
| Site Reference ID/Investigator# 18882 | Meridian | Idaho | 83642 | United States |
| Site Reference ID/Investigator# 7823 | Chicago | Illinois | 60617 | United States |
| Site Reference ID/Investigator# 7249 | Evergreen Park | Illinois | 60805 | United States |
| Site Reference ID/Investigator# 7816 | Bethesda | Maryland | 20814 | United States |
| Site Reference ID/Investigator# 18881 | Rockville | Maryland | 20852 | United States |
| Site Reference ID/Investigator# 7817 | Springfield | Massachusetts | 01107 | United States |
| Site Reference ID/Investigator# 7245 | Detroit | Michigan | 48202 | United States |
| Site Reference ID/Investigator# 7248 | Royal Oak | Michigan | 48073 | United States |
| Site Reference ID/Investigator# 8868 | Kansas City | Missouri | 64128 | United States |
| Site Reference ID/Investigator# 7828 | St Louis | Missouri | 63110 | United States |
| Site Reference ID/Investigator# 14442 | Omaha | Nebraska | 68131-3403 | United States |
| Site Reference ID/Investigator# 6567 | Winston-Salem | North Carolina | 27103 | United States |
| Site Reference ID/Investigator# 7262 | Winston-Salem | North Carolina | 27157-1045 | United States |
| Site Reference ID/Investigator# 7826 | Allentown | Pennsylvania | 18103 | United States |
| Site Reference ID/Investigator# 8865 | Chattanooga | Tennessee | 37404 | United States |
| Site Reference ID/Investigator# 7261 | Houston | Texas | 77004 | United States |
| Site Reference ID/Investigator# 8058 | Houston | Texas | 77099 | United States |
| Site Reference ID/Investigator# 7830 | San Antonio | Texas | 78229 | United States |
| Site Reference ID/Investigator# 7825 | Murray | Utah | 84157-7000 | United States |
| Site Reference ID/Investigator# 8866 | Provo | Utah | 84604 | United States |
| Site Reference ID/Investigator# 7263 | Fairfax | Virginia | 22033 | United States |
| Site Reference ID/Investigator# 8493 | Adelaide | 5000 | Australia |
| Site Reference ID/Investigator# 8506 | Liverpool | 2170 | Australia |
| Site Reference ID/Investigator# 8507 | Parkville | 3050 | Australia |
| Site Reference ID/Investigator# 9581 | Reservoir | 3073 | Australia |
| Site Reference ID/Investigator# 9582 | Richmond | 3121 | Australia |
| Site Reference ID/Investigator# 8500 | Westmead | 2145 | Australia |
| Site Reference ID/Investigator# 8245 | Prague | 12808 | Czechia |
| Site Reference ID/Investigator# 8246 | Prague | 14021 | Czechia |
| Site Reference ID/Investigator# 8499 | Prague | 16900 | Czechia |
| Site Reference ID/Investigator# 6692 | Dortmund | 44263 | Germany |
| Site Reference ID/Investigator# 9723 | Düsseldorf | 40210 | Germany |
| Site Reference ID/Investigator# 6630 | Lübeck | 23538 | Germany |
| Site Reference ID/Investigator# 7268 | Nettetal | 41334 | Germany |
| Site Reference ID/Investigator# 6622 | Würzburg | 97080 | Germany |
| Site Reference ID/Investigator# 10626 | Lido di Camaiore | 55041 | Italy |
| Site Reference ID/Investigator# 8070 | Naples | 80131 | Italy |
| Site Reference ID/Investigator# 8060 | Rome | 00165 | Italy |
| Site Reference ID/Investigator# 8519 | Lodz | 90-153 | Poland |
| Site Reference ID/Investigator# 7702 | Humacao | 00791 | Puerto Rico |
| Site Reference ID/Investigator# 7269 | Ponce | 00717-1322 | Puerto Rico |
| Site Reference ID/Investigator# 7818 | Rio Piedras | 00935 | Puerto Rico |
| Site Reference ID/Investigator# 7270 | San Juan | 00909 | Puerto Rico |
| Site Reference ID/Investigator# 7712 | San Juan | 00918 | Puerto Rico |
| Site Reference ID/Investigator# 7266 | Toa Baja | 00949 | Puerto Rico |
| Site Reference ID/Investigator# 8881 | Bucharest | 010731 | Romania |
| Site Reference ID/Investigator# 8518 | Bucharest | 022328 | Romania |
| Site Reference ID/Investigator# 8514 | Iași | 700503 | Romania |
| Site Reference ID/Investigator# 22682 | Moscow | 105229 | Russia |
| Site Reference ID/Investigator# 8009 | Moscow | 123182 | Russia |
| Site Reference ID/Investigator# 7251 | Moscow | 125284 | Russia |
| Site Reference ID/Investigator# 7250 | Moscow | 127473 | Russia |
| Site Reference ID/Investigator# 8883 | Barcelona | 08003 | Spain |
| Site Reference ID/Investigator# 8358 | Barcelona | 08035 | Spain |
| Site Reference ID/Investigator# 8355 | Madrid | 28007 | Spain |
| Site Reference ID/Investigator# 8356 | Madrid | 28041 | Spain |
| Site Reference ID/Investigator# 8882 | Santander (Cantabria) | 39008 | Spain |
| Site Reference ID/Investigator# 8884 | Taipei | 10002 | Taiwan |
| Site Reference ID/Investigator# 8228 | Taipei | Taiwan |
| Site Reference ID/Investigator# 8229 | Taoyuan | Taiwan |
| Site Reference ID/Investigator# 8234 | Xinzhuang | Taiwan |
| Site Reference ID/Investigator# 8823 | Coventry | CV2 2DX | United Kingdom |
| Derived |
| Thadhani R, Appelbaum E, Pritchett Y, Chang Y, Wenger J, Tamez H, Bhan I, Agarwal R, Zoccali C, Wanner C, Lloyd-Jones D, Cannata J, Thompson BT, Andress D, Zhang W, Packham D, Singh B, Zehnder D, Shah A, Pachika A, Manning WJ, Solomon SD. Vitamin D therapy and cardiac structure and function in patients with chronic kidney disease: the PRIMO randomized controlled trial. JAMA. 2012 Feb 15;307(7):674-84. doi: 10.1001/jama.2012.120. |
| 21242674 | Derived | Thadhani R, Appelbaum E, Chang Y, Pritchett Y, Bhan I, Agarwal R, Zoccali C, Wanner C, Lloyd-Jones D, Cannata J, Thompson T, Audhya P, Andress D, Zhang W, Ye J, Packham D, Singh B, Zehnder D, Manning WJ, Pachika A, Solomon SD. Vitamin D receptor activation and left ventricular hypertrophy in advanced kidney disease. Am J Nephrol. 2011;33(2):139-49. doi: 10.1159/000323551. Epub 2011 Jan 18. |
| 18591942 | Derived | Thadhani R. Targeted ablation of the vitamin D 1alpha-hydroxylase gene: getting to the heart of the matter. Kidney Int. 2008 Jul;74(2):141-3. doi: 10.1038/ki.2008.219. |
| FG001 |
| Placebo |
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Long-term Follow-up Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Paricalcitol | Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period. |
| BG001 | Placebo | Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Baseline RAAS Status | Baseline renin angiotensin-aldosterone system (RAAS) status refers to whether or not (yes/no) the participant was receiving RAAS inhibitor therapy at baseline. | Number | participants |
| |||||||||||||||||
| Diabetic Status | Number | participants |
| ||||||||||||||||||
| Age at Beginning of Long term Follow-up Period | Age demographics for the long-term follow-up population include data for 65 and 72 participants in the paricalcitol and placebo groups, respectively. | Mean | Standard Deviation | years |
| ||||||||||||||||
| Gender at Beginning of Long term Follow-up Period | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI) | 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. | 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. | Posted | Least Squares Mean | Standard Error | grams/meter^2.7 | Baseline to 48 weeks |
|
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| Secondary | Change in Diastolic Mitral Annular Relaxation Velocity (E') | Diastolic mitral annular relaxation velocity (lateral E wave velocity; E') is a measure of diastolic function. | The intent-to-treat (ITT) population, participants with available data. | Posted | Least Squares Mean | Standard Error | centimeters/second | Baseline to 48 weeks |
|
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| Secondary | Change in Ratio of Peak E Wave Velocity to Lateral E Wave Velocity (E/E') | The ratio of peak E wave velocity to lateral E wave velocity (E/E') is a measure of diastolic function. | The intent-to-treat (ITT) population, participants with available data. | Posted | Least Squares Mean | Standard Error | ratio | Baseline to 48 weeks |
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| Secondary | Change in E-wave Deceleration Time (DT) | E-wave deceleration time (DT) is a measure of diastolic function. | The intent-to-treat (ITT) population, participants with available data. | Posted | Least Squares Mean | Standard Error | seconds | Baseline to 48 weeks |
|
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| Secondary | Change in Isovolumetric Relaxation Time (IVRT) | Isovolumetric relaxation time (IVRT) is a measure of diastolic function. | The intent-to-treat (ITT) population, participants with available data. | Posted | Least Squares Mean | Standard Error | seconds | Baseline to 48 weeks |
|
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| Secondary | Change in Left Atrial Volume | Left atrial volume is a measure of diastolic function. | The intent-to-treat (ITT) population, participants with available data. | Posted | Least Squares Mean | Standard Error | milliliters | Baseline to 48 weeks |
|
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| Secondary | Change in Plasma Triiodothyronine (T3) | Plasma triiodothyronine (T3) is a biological and inflammatory marker. | The intent-to-treat (ITT) population, participants with available data. | Posted | Least Squares Mean | Standard Error | nanomoles/liter | Baseline to 48 weeks |
|
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| Secondary | Change in Interleukin-6 (IL-6) | Interleukin-6 (IL-6) is a biological and inflammatory marker. | The intent-to-treat (ITT) population, participants with available data. | Posted | Least Squares Mean | Standard Error | nanograms/liter | Baseline to 48 weeks |
|
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| Secondary | Change in Troponin-T | Troponin-T is a biological and inflammatory marker. | The intent-to-treat (ITT) population, participants with available data. | Posted | Least Squares Mean | Standard Error | micrograms/liter | Baseline to 48 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in B-type Natriuretic Peptide (BNP) | B-type natriuretic peptide (BNP) is a biological and inflammatory marker. | The intent-to-treat (ITT) population, participants with available data. | Posted | Least Squares Mean | Standard Error | log nanograms/liter | Baseline to 48 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in High Sensitivity C-reactive Protein (hsCRP) | High sensitivity C-reactive protein (hsCRP) is a biological and inflammatory marker. | The intent-to-treat (ITT) population, participants with available data. | Posted | Least Squares Mean | Standard Error | milligrams/liter | Baseline to 48 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Progression of Thoraco-abdominal Aortic Plaque Volume | Change from baseline to Week 48 in thoraco-abdominal aortic plaque volume. | The intent-to-treat (ITT) population, participants with available data. | Posted | Least Squares Mean | Standard Error | milliliters | Baseline to 48 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Progression of Thoraco-abdominal Aortic Wall Volume | Change from baseline to Week 48 in thoraco-abdominal aortic wall volume | The intent-to-treat (ITT) population, participants with available data. | Posted | Least Squares Mean | Standard Error | milliliters | Baseline to 48 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Progression of Aortic Compliance | Change from baseline to Week 48 in aortic compliance. | The intent-to-treat (ITT) population, participants with available data. | Posted | Least Squares Mean | Standard Error | 10^-4 cm^2/mmHg | Baseline to 48 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Progression of Left Ventricular End-systolic Volume Index | Change from baseline to Week 48 in left ventricular end-systolic volume index. | The intent-to-treat (ITT) population, participants with available data. | Posted | Least Squares Mean | Standard Error | milliliters/meter^2.7 | Baseline to 48 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Progression of Left Ventricular End-diastolic Volume Index | Change from baseline to Week 48 in left ventricular end-diastolic volume index. | The intent-to-treat (ITT) population, participants with available data. | Posted | Least Squares Mean | Standard Error | milliliters/meter^2.7 | Baseline to 48 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Progression of Left Ventricular Ejection Fraction | Change from baseline to Week 48 in left ventricular ejection fraction. | The intent-to-treat (ITT) population, participants with available data. | Posted | Least Squares Mean | Standard Error | percent | Baseline to 48 weeks |
|
|
All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period.
AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paricalcitol: Treatment Period | Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. | 20 | 115 | 75 | 115 | ||
| EG001 | Placebo: Treatment Period | Participants received 2 placebo capsules once a day for up to 48 weeks. | 20 | 112 | 68 | 112 | ||
| EG002 | Paricalcitol: Long-term Follow-up | Participants who received paricalcitol and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period. | 18 | 65 | 4 | 65 | ||
| EG003 | Placebo: Long-term Follow-up | Participants who received placebo and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period. | 13 | 72 | 8 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Scrotal abscess | Infections and infestations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Diabetic foot | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Autoimmune thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Aortic valve disease | Cardiac disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Congenital cystic kidney disease | Congenital, familial and genetic disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Angle closure glaucoma | Eye disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Small intestine obstruction | Gastrointestinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Cardiac death | General disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Bronchitis | Injury, poisoning and procedural complications | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Femoral neck injury | Injury, poisoning and procedural complications | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Tetany | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Intracranial haematoma | Nervous system disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Post-traumatic epilepsy | Nervous system disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Vesicourteric reflux | Renal and urinary disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Pickwickian syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.0 / 14.1 | Systematic Assessment |
|
AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D017379 | Hypertrophy, Left Ventricular |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
Not provided
Not provided
| ID | Term |
|---|---|
| C084656 | paricalcitol |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Other |
|
| >=65 years |
|
| Male |
|
| No |
|
| Type II |
|
| None |
|
| Male |
|
|
|
|
|
|
|
|
|
|
|
|
|
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