Back to resultsEffect of Paricalcitol Over Vessel Wall (MICROBUB)
Primary Purpose
Nephropathy
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Paricalcitol
Sponsored by
About this trial
This is an interventional treatment trial for Nephropathy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Usual treatment.
Arm Description
Patient will take one pill of paricalcitol a day.
Patient allocated to this arm will only take his/her habitual treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02372695
First Posted
March 5, 2013
Last Updated
February 20, 2015
Sponsor
Effice Servicios Para la Investigacion S.L.
Collaborators
Jaume Arnó Renal Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02372695
Brief Title
Effect of Paricalcitol Over Vessel Wall
Acronym
MICROBUB
Official Title
Effect of Paricalcitol Over Vessel Wall: Pleiotropic Analogues Vitamin D Effects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
Protocol showed to be inappropriate for the evaluation of the selected patients
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Effice Servicios Para la Investigacion S.L.
Collaborators
Jaume Arnó Renal Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patient will take one pill of paricalcitol a day.
Arm Title
Usual treatment.
Arm Type
No Intervention
Arm Description
Patient allocated to this arm will only take his/her habitual treatment
Intervention Type
Drug
Intervention Name(s)
Paricalcitol
Other Intervention Name(s)
Zemplar- 1 ug/day
Primary Outcome Measure Information:
Title
Prevention on vessels progression based on paricalcitol intake.
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.
Time Frame
participants will be followed for the duration of whole study, an expected average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Vittoria Arcidiacono, Ph D
Organizational Affiliation
Hospital Universitario Arnau de Vilanova de Lleida.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effect of Paricalcitol Over Vessel Wall
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