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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
227
2 µg capsule
placebo capsule
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.
Time frame: Baseline to 48 weeks
Change in Diastolic Mitral Annular Relaxation Velocity (E')
Diastolic mitral annular relaxation velocity (lateral E wave velocity; E') is a measure of diastolic function.
Time frame: Baseline to 48 weeks
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.
Time frame: Baseline to 48 weeks
Change in E-wave Deceleration Time (DT)
E-wave deceleration time (DT) is a measure of diastolic function.
Time frame: Baseline to 48 weeks
Change in Isovolumetric Relaxation Time (IVRT)
Isovolumetric relaxation time (IVRT) is a measure of diastolic function.
Time frame: Baseline to 48 weeks
Change in Left Atrial Volume
Left atrial volume is a measure of diastolic function.
Time frame: Baseline to 48 weeks
Change in Plasma Triiodothyronine (T3)
Plasma triiodothyronine (T3) is a biological and inflammatory marker.
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Site Reference ID/Investigator# 8062
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Time frame: Baseline to 48 weeks
Change in Interleukin-6 (IL-6)
Interleukin-6 (IL-6) is a biological and inflammatory marker.
Time frame: Baseline to 48 weeks
Change in Troponin-T
Troponin-T is a biological and inflammatory marker.
Time frame: Baseline to 48 weeks
Change in B-type Natriuretic Peptide (BNP)
B-type natriuretic peptide (BNP) is a biological and inflammatory marker.
Time frame: Baseline to 48 weeks
Change in High Sensitivity C-reactive Protein (hsCRP)
High sensitivity C-reactive protein (hsCRP) is a biological and inflammatory marker.
Time frame: 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.
Time frame: 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
Time frame: Baseline to 48 weeks
Change in Progression of Aortic Compliance
Change from baseline to Week 48 in aortic compliance.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 48 weeks
Change in Progression of Left Ventricular Ejection Fraction
Change from baseline to Week 48 in left ventricular ejection fraction.
Time frame: Baseline to 48 weeks