| Outcome Measures: |
Primary: Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI), 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., Baseline, 24 Weeks, and 48 Weeks/Early Termination | 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., Mitral Annular relaxation velocity is a measure of diastolic heart function., Baseline, 24 Weeks, and 48 Weeks/Early Termination|Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Isovolumetric Relaxation Time (IVRT) Over 48 Weeks., Isovolumetric relaxation time is a measure of diastolic heart function., Baseline, 24 Weeks, and 48 Weeks/Early Termination|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., The ratio of peak E-wave velocity to lateral e-wave velocity is a measure of diastolic heart function., Baseline, Week 24, and Week 48/Early Termination|Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function E-wave Deceleration Time (DT) Over 48 Weeks, E-wave deceleration time is a measure of diastolic heart function., Baseline, 24 Weeks, and 48 Weeks/Early Termination|Change From Baseline in Biological Marker Triiodothyronine (T3)., 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., Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|Change From Baseline in Biological Marker Plasma Troponin-T Over 48 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., Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|Change From Baseline in Biological Marker Plasma Interleukin-6 (IL-6) Over 48 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., Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|Change From Baseline in Biological Marker Plasma High Sensitivity C-reactive Protein (hsCRP) Over 48 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., Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|Change From Baseline in Biological Marker Plasma B-Type Natriuretic Peptide (BNP), 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., Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
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| Locations: |
Arizona Kidney Disease & Hypertension Center, Phoenix, Arizona, 85027, United States|Southwest Kidney Institute, Tempe, Arizona, 85284, United States|National Institute of Clinical Research, Bakersfield, California, 93309, United States|National Institute of Clinical Research, Los Angeles, California, 90017, United States|University of Southern California Kidney Center, Los Angeles, California, 90033, United States|North American Research Institute - California Kidney Specialist, San Dimas, California, 91773, United States|Kidney Center of Simi Valley, Simi Valley, California, 93065, United States|Western Nephrology and Metabolic bone disease, Arvada, Colorado, 80002, United States|Western Nephrology, Westminster, Colorado, 80031, United States|Washington Nephrology Associates, LLP, Washington, District of Columbia, 20017, United States|Fresenius Dialysis - Carrollwood, Tampa, Florida, 33624, United States|FMC-NA Central Atlanta, Atlanta, Georgia, 30329, United States|University of Illinois at Chicago - Nephrology Research, Chicago, Illinois, 60612, United States|The University of Chicago - Stony Island Dialysis Unit, Chicago, Illinois, 60617, United States|Evanston Northwestern Healthcare Corp. - Division of Nephrology, Evanston, Illinois, 60201, United States|Research By Design, LLC, Evergreen Park, Illinois, 60805, United States|North Suburban Nephrology, Gurnee, Illinois, 60031, United States|Biolab Research LLC, Rockville, Maryland, 20852, United States|Fresenius Medical Care, Kalamazoo, Michigan, 49007, United States|V.A. Medical Center Research, Kansas City, Missouri, 64128, United States|Washington University School of Medicine - Division of Renal Disease, St. Louis, Missouri, 63110, United States|Creighton University Medical Center, Omaha, Nebraska, 68131, United States|Brookdale Physicians Dialysis Associates, Brooklyn, New York, 11212, United States|Nephrology Associates, PLLC, Winston-Salem, North Carolina, 27103-7108, United States|MetroHealth Medical Center, Cleveland, Ohio, 44109, United States|G. Edward Newman, MD, LLC, Knoxville, Tennessee, 37923, United States|V.A. Tennessee Valley Healthcare System, Nashville, Tennessee, 37212, United States|Southwest Houston Research, Ltd, Houston, Texas, 77099, United States|The University of Texas - Health Science Center at San Antonio, San Antonio, Texas, 78229, United States|Liverpool Hospital - Renal Unit, Liverpool, New South Wales, 2170, Australia|Westmead Hospital - Dept. of Renal Medicine, Sydney, New South Wales, 2145, Australia|The Princess Alexandra Hospital - Nephrology Dept., Wooloongabba, Queensland, 4102, Australia|Royal Melbourne Hospital - Dept. of Nephrology, Parkville, Victoria, 3050, Australia|Faculty Hospital Brno, Brno, 62500, Czech Republic|FN Pizen Lochotin - Charles University Teaching Hospital, Pizen, 304 60, Czech Republic|IKEM - Nephrology Dept., Prague 4, 140 21, Czech Republic|1st LF UK - Nephrology Dept., Praha 2, 120 08, Czech Republic|1st LF UK - Nephrology Dept. Strahov, Praha 6, 169 00, Czech Republic|KfH Nierenzentrum, Coburg, 96450, Germany|Gemeinschaftspraxis Dialyse, Dortmund, 44263, Germany|Gemeinschaftspraxix Karlstrasse, Dusseldorf, 40210, Germany|Niren-, Dochdruck und Dialysepraxis, Nettetal, 41334, Germany|Wurzburg, 97080, Germany|IASO General - Renal Unit, Athens, 15562, Greece|Papageorgiou General Hospital of Thessaloniki, Thessaloniki, 56403, Greece|Bologna, 40138, Italy|Monza, 20052, Italy|Pavia, 27100, Italy|Trieste, 34125, Italy|Katowice, 40-027, Poland|Lodz, 90-153, Poland|Szczecin, 70-111, Poland|Warszawa, 02-006, Poland|Warszawa, 02-507, Poland|Fresenius Medical Care, Caguas, 00725, Puerto Rico|University of Puerto Rico, Rio Piedras, 00935, Puerto Rico|Spitalul "Dr. C. Davila" - Clinica de Nefrologie, Bucuresti, 013221, Romania|Institut Clinic Fundeni - Clinica Medicine Interna/Nefrologie, Bucuresti, 022328, Romania|Nefromed Dialysis Centre Cluj, Cluj-Napoca, 400006, Romania|Spitalul Clinic Judetean Cluj - Clinica de Nefrologie, Cluj-Napoca, 400006, Romania|Spitalul Clinic "Dr. C. I. Parhon" - Clinica de Nefrologie, Iasi, 700503, Romania|City Clinical Hospital #52, Moscow, 123182, Russian Federation|Moscow City Clinical Hospital named after Botkin, Moscow, 125284, Russian Federation|Hospital for War Veterans #2, Moscow, 127473, Russian Federation|Servicio de Nefrologia - Planta Baja, Cordoba, 14004, Spain|Fundacion Jimenez Diaz - Servicio de Nefrologia, Madrid, 28040, Spain|Hospital Universitario Son Dureta, Palma de Mallorca, 07014, Spain|Clinica Universitaria de la Universidad de Navarra, Pamplona, 31008, Spain|Hospital Universitario Virgen del Rocio - Servicio de Nefrologia, Sevilla, 41013, Spain|Hsin-Jen Hospital, Hsin-Chuang City, Taiwan|Cheng Hsin Rehabilitation Medical Center, Taipei, Taiwan|National Taiwan University Hospital, Taipei, Taiwan|Chang Gung Memorial Hospital, Taoyuan, Taiwan|University Hospitals Coventry and Warwickshire NHS Trust - University Hospital (UHCW), Coventry, CV2 2DX, United Kingdom|Hammersmith Hospital, London, W12 0NN, United Kingdom|Salford Royal NHS Foundation Trust - Dept. of Nephrology, Salford, M6 8HD, United Kingdom
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