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Effect of Paricalcitol Over Vessel Wall (MICROBUB)

E

Effice Research

Status and phase

Terminated
Phase 4

Conditions

Nephropathy

Treatments

Drug: Paricalcitol

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02372695
MICROBUB-2011-01
2011-002554-30 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Treatment
Experimental group
Description:
Patient will take one pill of paricalcitol a day.
Treatment:
Drug: Paricalcitol
Usual treatment.
No Intervention group
Description:
Patient allocated to this arm will only take his/her habitual treatment

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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