Effect of Paricalcitol Over Vessel Wall

Overview

To provide evidence based prospectives of the potential benefit effects of paricalcitol, an analog of vitamin D, over the prevention / retardation of the progression of neoangiogenesis (vessels), atherosclerosis and vascular calcification.

Full Title of Study: “Effect of Paricalcitol Over Vessel Wall: Pleiotropic Analogues Vitamin D Effects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2013

Detailed Description

Providing prospective results based on evidence of potential beneficial effects of paricalcitol, an analogue of vitamin D in the prevention / delay of progression of neoangiogenesis (vessels), atherosclerosis and vascular calcification.

Interventions

  • Drug: Paricalcitol

Arms, Groups and Cohorts

  • Experimental: Treatment
    • Patient will take one pill of paricalcitol a day.
  • No Intervention: Usual treatment.
    • Patient allocated to this arm will only take his/her habitual treatment

Clinical Trial Outcome Measures

Primary Measures

  • Prevention on vessels progression based on paricalcitol intake.
    • Time Frame: participants will be followed for the duration of whole study, an expected average of 1 year
    • Providing prospective results based on evidence of potential beneficial effects of paricalcitol, an analogue of vitamin D in the prevention / delay of progression of neoangiogenesis (vessels), atherosclerosis and vascular calcification.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients aged between 50 and 75 years. – 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). – No exclusion criteria for the use of contrast. Exclusion Criteria:

  • Allergic reaction to sulfur hexafluoride. – 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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Effice Servicios Para la Investigacion S.L.
  • Collaborator
    • Jaume Arnó Renal Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Maria Vittoria Arcidiacono, Ph D, Principal Investigator, Hospital Universitario Arnau de Vilanova de Lleida.

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