The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4
NCT ID: NCT00497146
Last Updated: 2013-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
227 participants
INTERVENTIONAL
2008-02-29
2012-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
paricalcitol
2 µg capsule
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.
placebo
placebo capsule
Interventions
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paricalcitol
2 µg capsule
placebo
placebo capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Ann Eldred, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 8062
Phoenix, Arizona, United States
Site Reference ID/Investigator# 8867
Tempe, Arizona, United States
Site Reference ID/Investigator# 8864
San Diego, California, United States
Site Reference ID/Investigator# 7257
San Dimas, California, United States
Site Reference ID/Investigator# 7727
Denver, Colorado, United States
Site Reference ID/Investigator# 8861
Miami, Florida, United States
Site Reference ID/Investigator# 7260
Orlando, Florida, United States
Site Reference ID/Investigator# 7725
Tampa, Florida, United States
Site Reference ID/Investigator# 7824
Tampa, Florida, United States
Site Reference ID/Investigator# 18882
Meridian, Idaho, United States
Site Reference ID/Investigator# 7823
Chicago, Illinois, United States
Site Reference ID/Investigator# 7249
Evergreen Park, Illinois, United States
Site Reference ID/Investigator# 7816
Bethesda, Maryland, United States
Site Reference ID/Investigator# 18881
Rockville, Maryland, United States
Site Reference ID/Investigator# 7817
Springfield, Massachusetts, United States
Site Reference ID/Investigator# 7245
Detroit, Michigan, United States
Site Reference ID/Investigator# 7248
Royal Oak, Michigan, United States
Site Reference ID/Investigator# 8868
Kansas City, Missouri, United States
Site Reference ID/Investigator# 7828
St Louis, Missouri, United States
Site Reference ID/Investigator# 14442
Omaha, Nebraska, United States
Site Reference ID/Investigator# 6567
Winston-Salem, North Carolina, United States
Site Reference ID/Investigator# 7262
Winston-Salem, North Carolina, United States
Site Reference ID/Investigator# 7826
Allentown, Pennsylvania, United States
Site Reference ID/Investigator# 8865
Chattanooga, Tennessee, United States
Site Reference ID/Investigator# 7261
Houston, Texas, United States
Site Reference ID/Investigator# 8058
Houston, Texas, United States
Site Reference ID/Investigator# 7830
San Antonio, Texas, United States
Site Reference ID/Investigator# 7825
Murray, Utah, United States
Site Reference ID/Investigator# 8866
Provo, Utah, United States
Site Reference ID/Investigator# 7263
Fairfax, Virginia, United States
Site Reference ID/Investigator# 8493
Adelaide, , Australia
Site Reference ID/Investigator# 8506
Liverpool, , Australia
Site Reference ID/Investigator# 8507
Parkville, , Australia
Site Reference ID/Investigator# 9581
Reservoir, , Australia
Site Reference ID/Investigator# 9582
Richmond, , Australia
Site Reference ID/Investigator# 8500
Westmead, , Australia
Site Reference ID/Investigator# 8245
Prague, , Czechia
Site Reference ID/Investigator# 8246
Prague, , Czechia
Site Reference ID/Investigator# 8499
Prague, , Czechia
Site Reference ID/Investigator# 6692
Dortmund, , Germany
Site Reference ID/Investigator# 9723
Düsseldorf, , Germany
Site Reference ID/Investigator# 6630
Lübeck, , Germany
Site Reference ID/Investigator# 7268
Nettetal, , Germany
Site Reference ID/Investigator# 6622
Würzburg, , Germany
Site Reference ID/Investigator# 10626
Lido di Camaiore, , Italy
Site Reference ID/Investigator# 8070
Naples, , Italy
Site Reference ID/Investigator# 8060
Rome, , Italy
Site Reference ID/Investigator# 8519
Lodz, , Poland
Site Reference ID/Investigator# 7702
Humacao, , Puerto Rico
Site Reference ID/Investigator# 7269
Ponce, , Puerto Rico
Site Reference ID/Investigator# 7818
Rio Piedras, , Puerto Rico
Site Reference ID/Investigator# 7270
San Juan, , Puerto Rico
Site Reference ID/Investigator# 7712
San Juan, , Puerto Rico
Site Reference ID/Investigator# 7266
Toa Baja, , Puerto Rico
Site Reference ID/Investigator# 8881
Bucharest, , Romania
Site Reference ID/Investigator# 8518
Bucharest, , Romania
Site Reference ID/Investigator# 8514
Iași, , Romania
Site Reference ID/Investigator# 22682
Moscow, , Russia
Site Reference ID/Investigator# 8009
Moscow, , Russia
Site Reference ID/Investigator# 7251
Moscow, , Russia
Site Reference ID/Investigator# 7250
Moscow, , Russia
Site Reference ID/Investigator# 8883
Barcelona, , Spain
Site Reference ID/Investigator# 8358
Barcelona, , Spain
Site Reference ID/Investigator# 8355
Madrid, , Spain
Site Reference ID/Investigator# 8356
Madrid, , Spain
Site Reference ID/Investigator# 8882
Santander (Cantabria), , Spain
Site Reference ID/Investigator# 8884
Taipei, , Taiwan
Site Reference ID/Investigator# 8228
Taipei, , Taiwan
Site Reference ID/Investigator# 8229
Taoyuan District, , Taiwan
Site Reference ID/Investigator# 8234
Xinzhuang, , Taiwan
Site Reference ID/Investigator# 8823
Coventry, , United Kingdom
Countries
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References
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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.
Related Links
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Related Info
Other Identifiers
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2007-001689-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M10-030
Identifier Type: -
Identifier Source: org_study_id
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