Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
50 participants
INTERVENTIONAL
2012-07-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
Patient will take one pill of paricalcitol a day.
Paricalcitol
Usual treatment.
Patient allocated to this arm will only take his/her habitual treatment
No interventions assigned to this group
Interventions
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Paricalcitol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic kidney disease stage 5 D or 4-5 No D as calculated glomerular filtration rate (MDRD).
* Concentration of intact parathyroid hormone (iPTH): 150-400 pg/ml.
* Plasma concentrations of 25 (OH) vitamin D \<30 ng/ml.
* Without vitamin D supplementation for 3 months before the study.
* Serum P\> 3.8 mg / dl.
* Serum Ca\> 9.8 mg / dl.
* No history of cardiovascular events (angina or myocardial infarction, stroke, peripheral arterial disease).
Exclusion Criteria
* Recent unstable cardiac symptoms.
* Patients with recent coronary intervention (\<7 days)
* Patients with class III and IV heart failure or severe arrhythmias.
* Severe pulmonary hypertension.
50 Years
75 Years
ALL
No
Sponsors
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Jaume Arnó Renal Foundation
OTHER
Effice Servicios Para la Investigacion S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Maria Vittoria Arcidiacono, Ph D
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Arnau de Vilanova de Lleida.
Other Identifiers
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2011-002554-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MICROBUB-2011-01
Identifier Type: -
Identifier Source: org_study_id
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