Effect of Paricalcitol Over Vessel Wall

Phase 4

Terminated

• Conditions: Nephropathy
• Interventions: Drug: Paricalcitol

• Registration Number: NCT02372695
• Lead Sponsor: Effice Servicios Para la Investigacion S.L.

Brief Summary

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.

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-03-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-20
• Last Update Submitted: 2015-02-20
• Study First Posted: 2015-02-26
• Last Update Posted: 2015-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Paricalcitol	Patient will take one pill of paricalcitol a day.

Primary Outcome Measures

Name	Time	Method
Prevention on vessels progression based on paricalcitol intake.	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.