NCT02372695

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_4

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
Last Updated

February 26, 2015

Status Verified

February 1, 2015

Enrollment Period

10 months

First QC Date

March 5, 2013

Last Update Submit

February 20, 2015

Conditions

Nephropathy

Outcome Measures

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.

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

Study Arms (2)

Treatment

EXPERIMENTAL

Patient will take one pill of paricalcitol a day.

Drug: Paricalcitol

Usual treatment.

NO INTERVENTION

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

Interventions

ParicalcitolDRUG
Also known as: Zemplar- 1 ug/day
Treatment

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Diseases

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Maria Vittoria Arcidiacono, Ph D

    Hospital Universitario Arnau de Vilanova de Lleida.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2013

First Posted

February 26, 2015

Study Start

July 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

February 26, 2015

Record last verified: 2015-02