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TerminatedNCT02372695MICROBUBUpdated Feb 26, 2015

Effect of Paricalcitol Over Vessel Wall

A Phase 4 interventional study of Paricalcitol in Nephropathy, sponsored by Effice Servicios Para la Investigacion S.L.. Terminated. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-02-26.

Sponsored by Effice Servicios Para la Investigacion S.L. · Phase 4, Interventional, and Treatment

Why this study was terminated
Protocol showed to be inappropriate for the evaluation of the selected patients
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Nephropathy

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03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 50 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

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Lead sponsor

This is the only study on the registry with Effice Servicios Para la Investigacion S.L. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Treatment

    Patient will take one pill of paricalcitol a day.

    Drug: Paricalcitol

  • No intervention
    Usual treatment.

    Patient allocated to this arm will only take his/her habitual treatment

Interventions

  • DrugParicalcitol

    Also known as: Zemplar- 1 ug/day

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: participants will be followed for the duration of whole study, an expected average of 1 year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02372695
Lead sponsor
Effice Servicios Para la Investigacion S.L.
Collaborators
Jaume Arnó Renal Foundation
Responsible party
Sponsor
First posted
Feb 26, 2015
Start date
Jul 2012
Primary completion
May 2013
Completion
May 2013
Last update
Feb 26, 2015

Study contacts

Maria Vittoria Arcidiacono, Ph D
principal investigator · Hospital Universitario Arnau de Vilanova de Lleida.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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