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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00497146
Registration number
NCT00497146
Ethics application status
Date submitted
3/07/2007
Date registered
6/07/2007
Date last updated
12/03/2013
Titles & IDs
Public title
The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4
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Scientific title
The PRIMO Study: Paricalcitol Capsules Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4
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Secondary ID [1]
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2007-001689-34
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Secondary ID [2]
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M10-030
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Universal Trial Number (UTN)
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Trial acronym
PRIMO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease
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Left Ventricular Hypertrophy
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Renal and Urogenital
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Other renal and urogenital disorders
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - paricalcitol
Treatment: Drugs - placebo
Experimental: 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.
Placebo comparator: 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.
Treatment: Drugs: paricalcitol
2 µg capsule
Treatment: Drugs: placebo
placebo capsule
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to 48 weeks
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Secondary outcome [1]
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Change in Diastolic Mitral Annular Relaxation Velocity (E')
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Assessment method [1]
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Diastolic mitral annular relaxation velocity (lateral E wave velocity; E') is a measure of diastolic function.
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Timepoint [1]
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Baseline to 48 weeks
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Secondary outcome [2]
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Change in Ratio of Peak E Wave Velocity to Lateral E Wave Velocity (E/E')
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Assessment method [2]
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The ratio of peak E wave velocity to lateral E wave velocity (E/E') is a measure of diastolic function.
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Timepoint [2]
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Baseline to 48 weeks
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Secondary outcome [3]
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Change in E-wave Deceleration Time (DT)
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Assessment method [3]
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E-wave deceleration time (DT) is a measure of diastolic function.
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Timepoint [3]
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Baseline to 48 weeks
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Secondary outcome [4]
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Change in Isovolumetric Relaxation Time (IVRT)
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Assessment method [4]
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Isovolumetric relaxation time (IVRT) is a measure of diastolic function.
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Timepoint [4]
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Baseline to 48 weeks
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Secondary outcome [5]
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Change in Left Atrial Volume
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Assessment method [5]
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Left atrial volume is a measure of diastolic function.
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Timepoint [5]
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Baseline to 48 weeks
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Secondary outcome [6]
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Change in Plasma Triiodothyronine (T3)
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Assessment method [6]
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Plasma triiodothyronine (T3) is a biological and inflammatory marker.
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Timepoint [6]
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Baseline to 48 weeks
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Secondary outcome [7]
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Change in Interleukin-6 (IL-6)
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Assessment method [7]
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Interleukin-6 (IL-6) is a biological and inflammatory marker.
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Timepoint [7]
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Baseline to 48 weeks
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Secondary outcome [8]
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Change in Troponin-T
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Assessment method [8]
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Troponin-T is a biological and inflammatory marker.
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Timepoint [8]
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Baseline to 48 weeks
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Secondary outcome [9]
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Change in B-type Natriuretic Peptide (BNP)
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Assessment method [9]
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B-type natriuretic peptide (BNP) is a biological and inflammatory marker.
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Timepoint [9]
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Baseline to 48 weeks
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Secondary outcome [10]
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Change in High Sensitivity C-reactive Protein (hsCRP)
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Assessment method [10]
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High sensitivity C-reactive protein (hsCRP) is a biological and inflammatory marker.
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Timepoint [10]
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Baseline to 48 weeks
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Secondary outcome [11]
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Change in Progression of Thoraco-abdominal Aortic Plaque Volume
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Assessment method [11]
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Change from baseline to Week 48 in thoraco-abdominal aortic plaque volume.
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Timepoint [11]
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Baseline to 48 weeks
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Secondary outcome [12]
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Change in Progression of Thoraco-abdominal Aortic Wall Volume
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Assessment method [12]
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Change from baseline to Week 48 in thoraco-abdominal aortic wall volume
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Timepoint [12]
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Baseline to 48 weeks
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Secondary outcome [13]
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Change in Progression of Aortic Compliance
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Assessment method [13]
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Change from baseline to Week 48 in aortic compliance.
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Timepoint [13]
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Baseline to 48 weeks
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Secondary outcome [14]
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Change in Progression of Left Ventricular End-systolic Volume Index
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Assessment method [14]
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Change from baseline to Week 48 in left ventricular end-systolic volume index.
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Timepoint [14]
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Baseline to 48 weeks
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Secondary outcome [15]
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Change in Progression of Left Ventricular End-diastolic Volume Index
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Assessment method [15]
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Change from baseline to Week 48 in left ventricular end-diastolic volume index.
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Timepoint [15]
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Baseline to 48 weeks
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Secondary outcome [16]
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Change in Progression of Left Ventricular Ejection Fraction
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Assessment method [16]
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Change from baseline to Week 48 in left ventricular ejection fraction.
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Timepoint [16]
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Baseline to 48 weeks
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Eligibility
Key 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:
* Females: Left ventricular (LV) ejection fraction greater than or equal to 50% and septal wall thickness between 11-17 mm; and,
* Males: LV ejection fraction greater than or equal to 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. 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).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Subject has previously been on active vitamin D therapy within the four weeks prior to the Screening Period
* Pregnant or lactating females
* Subject is expected to initiate renal replacement therapy within one year
* Subject is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except topical or inhaled glucocorticoids)
* Subject had clinically significant coronary artery disease (CAD) within 3 months prior to the Screening Period, defined as either hospitalization for myocardial infarction (MI) or unstable angina; new onset angina with positive functional study or coronary angiogram revealing stenosis; or coronary revascularization procedure.
* Subject had major cardiac valve abnormality linked with LVH and/or diastolic dysfunction, defined as either aortic valve area = 1.5 cm^2 or a mean gradient of > 20 mmHg; or regurgitation lesions; more than moderate mitral regurgitation, or more than moderate aortic regurgitation.
* Subject had asymmetric septal hypertrophy defined as septal wall thickness/posterior wall thickness ratio > 1.5 based on screening echocardiogram.
* Subject had a severe cerebrovascular accident (CVA) within the last 3 months (e.g., hemorrhagic) prior to screening.
* Subject had full remission from a malignancy for less than 1 year except completely excised non-melanoma skin cancer (e.g., basal or squamous carcinoma) or any history of bone metastasis.
* Subject had comorbid conditions (e.g., advanced malignancy, advanced liver disease) with a life expectancy less than 1 year.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2012
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Sample size
Target
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Accrual to date
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Final
227
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Site Reference ID/Investigator# 8493 - Adelaide
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Recruitment hospital [2]
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Site Reference ID/Investigator# 8506 - Liverpool
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Recruitment hospital [3]
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Site Reference ID/Investigator# 8507 - Parkville
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Recruitment hospital [4]
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Site Reference ID/Investigator# 9581 - Reservoir
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Recruitment hospital [5]
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Site Reference ID/Investigator# 9582 - Richmond
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Recruitment hospital [6]
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Site Reference ID/Investigator# 8500 - Westmead
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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2170 - Liverpool
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Recruitment postcode(s) [3]
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3050 - Parkville
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Recruitment postcode(s) [4]
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3073 - Reservoir
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Recruitment postcode(s) [5]
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3121 - Richmond
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Recruitment postcode(s) [6]
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2145 - Westmead
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Recruitment outside Australia
Country [1]
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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Nebraska
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United States of America
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North Carolina
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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Utah
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Virginia
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Czech Republic
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Prague 4
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Czech Republic
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Prague 6
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Czech Republic
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Prague
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Germany
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Dortmund
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Germany
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Duesseldorf
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Germany
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Luebeck
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Germany
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Nettetal
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Germany
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Wuerzburg
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Italy
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Lido di Camaiore
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Italy
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Naples
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Italy
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Rome
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Poland
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Lodz
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Puerto Rico
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Humacao
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Puerto Rico
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Ponce
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Puerto Rico
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Rio Piedras
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Puerto Rico
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San Juan
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Puerto Rico
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Toa Baja
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Romania
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Bucharest
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Romania
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Iasi
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Russian Federation
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Moscow
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Spain
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Barcelona
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Spain
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Madrid
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Country [40]
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Spain
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Santander (Cantabria)
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Country [41]
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Taiwan
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Hsin-Chuang City
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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United Kingdom
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State/province [44]
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Coventry
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie (prior sponsor, Abbott)
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Massachusetts General Hospital
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT00497146
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Trial related presentations / publications
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. 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. 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. 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.
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Public notes
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Contacts
Principal investigator
Name
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Ann Eldred, MD
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00497146
Download to PDF