Effect of Paricalcitol Over Vessel Wall (MICROBUB)

Effect of Paricalcitol Over Vessel Wall: Pleiotropic Analogues Vitamin D Effects

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.

Study Overview

• Status: Terminated
• Conditions: Nephropathy
• Intervention / Treatment: Drug: Paricalcitol

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Patient will take one pill of paricalcitol a day.	Drug: Paricalcitol; Other Names: Zemplar- 1 ug/day
No Intervention: Usual treatment.; Patient allocated to this arm will only take his/her habitual treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevention on vessels progression based on paricalcitol intake.	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.	participants will be followed for the duration of whole study, an expected average of 1 year

Collaborators and Investigators

• Sponsor: Effice Servicios Para la Investigacion S.L.
• Collaborators: Jaume Arnó Renal Foundation
• Investigators: Principal Investigator: Maria Vittoria Arcidiacono, Ph D, Hospital Universitario Arnau de Vilanova de Lleida.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: March 5, 2013
• First Submitted That Met QC Criteria: February 20, 2015
• First Posted (Estimate): February 26, 2015

Study Record Updates

• Last Update Posted (Estimate): February 26, 2015
• Last Update Submitted That Met QC Criteria: February 20, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: MICROBUB-2011-01; 2011-002554-30 (EudraCT Number)