NephropathyPhase 4MICROBUBNCT02372695
Effect of Paricalcitol Over Vessel Wall
A Phase 4 study testing Paricalcitol in people with Nephropathy, run by Effice Servicios Para la Investigacion S.L..
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Nephropathy
- What is being tested?
- Paricalcitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to May 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nephropathy
- Being tested
- Paricalcitol
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParicalcitolDrug
Also called Zemplar- 1 ug/day
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patient will take one pill of paricalcitol a day. Receives: Drug: Paricalcitol |
| Usual treatment. | No intervention | Patient allocated to this arm will only take his/her habitual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: participants will be followed for the duration of whole study, an expected average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startJul 2012
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: Protocol showed to be inappropriate for the evaluation of the selected patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Effice Servicios Para la Investigacion S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jaume Arnó Renal Foundation
- Responsible party
- Sponsor
- Investigators
- Maria Vittoria Arcidiacono, Ph D, Principal investigator, Hospital Universitario Arnau de Vilanova de Lleida.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372695
- Sponsor's protocol ID
- MICROBUB-2011-01
- Other IDs
- 2011-002554-30
- Acronym
- MICROBUB
- Status last verified
- Feb 2015
- First submitted
- 5 Mar 2013
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Paricalcitol Over Vessel Wall: Pleiotropic Analogues Vitamin D Effects
- ClinicalTrials.gov ID
- NCT02372695
- Acronym / sponsor ID
- MICROBUB / MICROBUB-2011-01
- Conditions
- Nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol showed to be inappropriate for the evaluation of the selected patients
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Effice Servicios Para la Investigacion S.L.Industry (pharma, biotech, devices)
- Collaborators
- Jaume Arnó Renal Foundation
- Study start
- Jul 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: ParicalcitolPatient will take one pill of paricalcitol a day. |
| Usual treatment. | No intervention | –Patient allocated to this arm will only take his/her habitual treatment |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParicalcitolAlso: Zemplar- 1 ug/day | Drug | Treatment |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Protocol showed to be inappropriate for the evaluation of the selected patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Vittoria Arcidiacono, Ph D principal investigator
Hospital Universitario Arnau de Vilanova de Lleida.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paricalcitol in people with Nephropathy, run by Effice Servicios Para la Investigacion S.L..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Protocol showed to be inappropriate for the evaluation of the selected patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2015; AzTrials last refreshed its copy on 5 Nov 2026.