Effect of Paricalcitol Over Vessel Wall

Nephropathy Clinical Trial

— MICROBUB  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02372695
• Other study ID #: MICROBUB-2011-01
• Secondary ID: 2011-002554-30
• Status: Terminated
• Phase: Phase 4
• First received: March 5, 2013
• Last updated: February 20, 2015
• Start date: July 2012
• Est. completion date: May 2013

Study information

• Verified date: February 2015
• Source: Effice Servicios Para la Investigacion S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nephropathy

Intervention

Drug:
• Paricalcitol

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Effice Servicios Para la Investigacion S.L.	Fundació Renal Jaume Arnó

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No