- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00616902
The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5 (PRIMO II)
Clinical Study Protocol M10-221 The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New South Wales
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Liverpool, New South Wales, Australia, 2170
- Liverpool Hospital - Renal Unit
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Sydney, New South Wales, Australia, 2145
- Westmead Hospital - Dept. of Renal Medicine
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Queensland
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Wooloongabba, Queensland, Australia, 4102
- The Princess Alexandra Hospital - Nephrology Dept.
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Victoria
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Parkville, Victoria, Australia, 3050
- Royal Melbourne Hospital - Dept. of Nephrology
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Brno, Czech Republic, 62500
- Faculty hospital Brno
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Pizen, Czech Republic, 304 60
- FN Pizen Lochotin - Charles University Teaching Hospital
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Prague 4, Czech Republic, 140 21
- IKEM - Nephrology Dept.
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Praha 2, Czech Republic, 120 08
- 1st LF UK - Nephrology Dept.
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Praha 6, Czech Republic, 169 00
- 1st LF UK - Nephrology Dept. Strahov
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Coburg, Germany, 96450
- KfH Nierenzentrum
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Dortmund, Germany, 44263
- Gemeinschaftspraxis Dialyse
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Dusseldorf, Germany, 40210
- Gemeinschaftspraxix Karlstrasse
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Nettetal, Germany, 41334
- Niren-, Dochdruck und Dialysepraxis
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Wurzburg, Germany, 97080
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Athens, Greece, 15562
- IASO General - Renal Unit
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Thessaloniki, Greece, 56403
- Papageorgiou General Hospital of Thessaloniki
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Bologna, Italy, 40138
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Monza, Italy, 20052
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Pavia, Italy, 27100
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Trieste, Italy, 34125
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Katowice, Poland, 40-027
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Lodz, Poland, 90-153
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Szczecin, Poland, 70-111
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Warszawa, Poland, 02-006
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Warszawa, Poland, 02-507
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Caguas, Puerto Rico, 00725
- Fresenius Medical Care
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Rio Piedras, Puerto Rico, 00935
- University of Puerto Rico
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Bucuresti, Romania, 013221
- Spitalul "Dr. C. Davila" - Clinica de Nefrologie
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Bucuresti, Romania, 022328
- Institut Clinic Fundeni - Clinica Medicine Interna/Nefrologie
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Cluj-Napoca, Romania, 400006
- Nefromed Dialysis Centre Cluj
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Cluj-Napoca, Romania, 400006
- Spitalul Clinic Judetean Cluj - Clinica de Nefrologie
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Iasi, Romania, 700503
- Spitalul Clinic "Dr. C. I. Parhon" - Clinica de Nefrologie
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Moscow, Russian Federation, 123182
- City Clinical Hospital #52
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Moscow, Russian Federation, 125284
- Moscow City Clinical Hospital named after Botkin
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Moscow, Russian Federation, 127473
- Hospital for War Veterans #2
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Cordoba, Spain, 14004
- Servicio de Nefrologia - Planta Baja
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Madrid, Spain, 28040
- Fundacion Jimenez Diaz - Servicio de Nefrologia
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Palma de Mallorca, Spain, 07014
- Hospital Universitario Son Dureta
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Pamplona, Spain, 31008
- Clinica Universitaria de la Universidad de Navarra
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Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocio - Servicio de Nefrologia
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Hsin-Chuang City, Taiwan
- Hsin-Jen Hospital
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Taipei, Taiwan
- National Taiwan University Hospital
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Taipei, Taiwan
- Cheng Hsin Rehabilitation Medical Center
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Taoyuan, Taiwan
- Chang Gung memorial hospital
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Coventry, United Kingdom, CV2 2DX
- University Hospitals Coventry and Warwickshire NHS Trust - University Hospital (UHCW)
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London, United Kingdom, W12 0NN
- Hammersmith Hospital
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Salford, United Kingdom, M6 8HD
- Salford Royal NHS Foundation Trust - Dept. of Nephrology
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Arizona
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Phoenix, Arizona, United States, 85027
- Arizona Kidney Disease & Hypertension Center
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Tempe, Arizona, United States, 85284
- Southwest Kidney Institute
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California
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Bakersfield, California, United States, 93309
- National Institute of Clinical Research
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Los Angeles, California, United States, 90017
- National Institute of Clinical Research
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Los Angeles, California, United States, 90033
- University of Southern California Kidney Center
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San Dimas, California, United States, 91773
- North American Research Institute - California Kidney Specialist
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Simi Valley, California, United States, 93065
- Kidney Center of Simi Valley
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Colorado
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Arvada, Colorado, United States, 80002
- Western Nephrology and Metabolic bone disease
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Westminster, Colorado, United States, 80031
- Western Nephrology
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District of Columbia
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Washington, District of Columbia, United States, 20017
- Washington Nephrology Associates, LLP
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Florida
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Tampa, Florida, United States, 33624
- Fresenius Dialysis - Carrollwood
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Georgia
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Atlanta, Georgia, United States, 30329
- FMC-NA Central Atlanta
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois at Chicago - Nephrology Research
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Chicago, Illinois, United States, 60617
- The University of Chicago - Stony Island Dialysis Unit
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Evanston, Illinois, United States, 60201
- Evanston Northwestern Healthcare Corp. - Division of Nephrology
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Evergreen Park, Illinois, United States, 60805
- Research by Design, LLC
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Gurnee, Illinois, United States, 60031
- North Suburban Nephrology
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Maryland
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Rockville, Maryland, United States, 20852
- Biolab Research LLC
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Michigan
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Kalamazoo, Michigan, United States, 49007
- Fresenius Medical Care
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Missouri
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Kansas City, Missouri, United States, 64128
- V.A. Medical Center Research
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St. Louis, Missouri, United States, 63110
- Washington University School of Medicine - Division of Renal Disease
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Nebraska
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Omaha, Nebraska, United States, 68131
- Creighton University Medical Center
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New York
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Brooklyn, New York, United States, 11212
- Brookdale Physicians Dialysis Associates
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North Carolina
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Winston-Salem, North Carolina, United States, 27103-7108
- Nephrology Associates, PLLC
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Ohio
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Cleveland, Ohio, United States, 44109
- MetroHealth Medical Center
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Tennessee
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Knoxville, Tennessee, United States, 37923
- G. Edward Newman, MD, LLC
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Nashville, Tennessee, United States, 37212
- V.A. Tennessee Valley Healthcare System
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Texas
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Houston, Texas, United States, 77099
- Southwest Houston Research, Ltd
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San Antonio, Texas, United States, 78229
- The University of Texas - Health Science Center at San Antonio
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Stage 5 CKD receiving chronic hemodialysis three times per week for >= 3 months and <= 12 months from date of Randomization (Day 1).
- Serum intact parathyroid hormone (iPTH) value between 100-350 pg/mL.
- Serum calcium level between 8.4-10.5 mg/dL (2.1-2.6 mmol/L).
- Phosphate < 7 mg/dL.
- Serum albumin >= 3.0 g/dL (30 g/L).
Echocardiogram results:
- For females, left ventricular (LV) ejection fraction >= 50% and septal wall thickness between 11-17 mm.
- For males, LV ejection fraction >= 50% and septal wall thickness between 12-18 mm.
- 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.
- A technically adequate baseline cardiac magnetic resonance imaging (MRI).
- If female, subject is not breast feeding or is not pregnant, or is not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile, or is of childbearing potential and practicing one of the following methods of birth control:
- Double-barrier method
- Hormonal contraceptives for at least three months prior to and during study drug administration
- Maintains a monogamous relationship with a vasectomized partner
- Total abstinence from sexual intercourse during the study.
Exclusion Criteria:
- Subject has previously been on active vitamin D therapy (calcitriol, paricalcitol, doxercalciferol, alfacalcidol) for a total duration greater than three months since the start of dialysis.
- Subject has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug.
- Subject is expected to receive an increased dose of RAAS inhibitor (Angiotensin converting enzyme inhibitor [ACEi], Angiotensin II receptor blocker [ARB] or aldosterone inhibitor) during the course of the study.
Subject has clinically significant coronary artery disease (CAD) within 3 months prior to the Screening Period, defined as one of the following:
- Hospitalization for myocardial infarction (MI) or unstable angina; or
- New onset angina with positive functional study or coronary angiogram revealing stenosis; or
- Coronary revascularization procedure.
Subject has major cardiac valve abnormality linked with left ventricular hypertrophy (LVH) and/or diastolic dysfunction, defined as one of the following:
- Aortic valve area <= 1.5 cm2 or a mean gradient of > 20 mmHg; or
- Regurgitation lesions; more than moderate mitral regurgitation or more than moderate aortic regurgitation.
- Subject has asymmetric septal hypertrophy.
- Subject has had a severe cerebrovascular accident (CVA) within the last three months (e.g., hemorrhagic) prior to screening.
- Full remission from a malignancy for less than one year except completely excised non-Melanoma skin cancer (e.g. basal or squamous carcinoma) or any history of bone metastasis.
- Subject has co-morbid conditions.
- Subject has received any investigational drug within 30 days prior to study drug administration or is currently enrolled in another clinical trial.
- Subject has poorly controlled hypertension.
- Subject has history of renal artery stenosis, primary aldosteronism or pheochromocytoma
- Subject is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except topical or inhaled glucocorticoids)
- Subject is currently receiving immunosuppressant therapy and/or high doses of glucocorticoids
- Subject is known to be HIV positive.
- Use of known inhibitors or inducers of cytochrome P450 3A (CYP3A) within two weeks prior to study drug administration
- Subject is contraindicated for the MRI examination
- Investigator considers subject unsuitable for any reason
- Subject has a history of drug or alcohol abuse within six months prior to screening
- Subject weighs more than 340 pounds (154 kg)
- Subject has had a liver transplant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Paricalcitol Injection 4 mcg/mL
Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis
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Paricalcitol Injection 4 mcg/mL intravenously three times a week during dialysis
Other Names:
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Placebo Comparator: Placebo Injection 4 mcg/mL
Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis
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Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)
Time Frame: Baseline, 24 Weeks, and 48 Weeks/Early Termination
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Echocardiographic Assessment of Diastolic Function Assessed by Evaluating Changes in Diastolic Mitral Annular Relaxation Velocity (E') Over 48 Weeks.
Time Frame: Baseline, 24 Weeks, and 48 Weeks/Early Termination
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Mitral Annular relaxation velocity is a measure of diastolic heart function.
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Baseline, 24 Weeks, and 48 Weeks/Early Termination
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Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Isovolumetric Relaxation Time (IVRT) Over 48 Weeks.
Time Frame: Baseline, 24 Weeks, and 48 Weeks/Early Termination
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Isovolumetric relaxation time is a measure of diastolic heart function.
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Baseline, 24 Weeks, and 48 Weeks/Early Termination
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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.
Time Frame: Baseline, Week 24, and Week 48/Early Termination
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The ratio of peak E-wave velocity to lateral e-wave velocity is a measure of diastolic heart function.
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Baseline, Week 24, and Week 48/Early Termination
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Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function E-wave Deceleration Time (DT) Over 48 Weeks
Time Frame: Baseline, 24 Weeks, and 48 Weeks/Early Termination
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E-wave deceleration time is a measure of diastolic heart function.
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Baseline, 24 Weeks, and 48 Weeks/Early Termination
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Change From Baseline in Biological Marker Triiodothyronine (T3).
Time Frame: Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
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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.
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Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
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Change From Baseline in Biological Marker Plasma Troponin-T Over 48 Weeks
Time Frame: Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
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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.
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Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
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Change From Baseline in Biological Marker Plasma Interleukin-6 (IL-6) Over 48 Weeks
Time Frame: Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
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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.
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Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
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Change From Baseline in Biological Marker Plasma High Sensitivity C-reactive Protein (hsCRP) Over 48 Weeks
Time Frame: Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
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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.
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Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
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Change From Baseline in Biological Marker Plasma B-Type Natriuretic Peptide (BNP)
Time Frame: Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
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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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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Dennis Andress, MD, Abbott
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Urologic Diseases
- Pathological Conditions, Anatomical
- Cardiomegaly
- Kidney Diseases
- Renal Insufficiency, Chronic
- Renal Insufficiency
- Hypertrophy
- Hypertrophy, Left Ventricular
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Ergocalciferols
Other Study ID Numbers
- M10-221
- 2007-005092-33 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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