Assess the stability / benefit of Cinacalcet treatment over conventional therapy based on bone metabolism, arterial stiffness and vascular calcification in advanced chronic renal failure

Conditions: Bone's disorders and mineral metabolism and vascular involvement
MedDRA version: 16.1Level: PTClassification code 10051753Term: Vascular calcificationSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Registration Number: EUCTR2013-002270-52-ES

Lead Sponsor: Hospital Universitari de Girona Dr.Josep Trueta

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Patients of both sexes, aged greater than or equal to 18.
2. Adult patients suffering from chronic kidney failure (stadium V)and less than 1 year in sustitutive treatment
3.Patients with secondary hyperparathyroidism: iPTH> 150 pg / ml before inclusion in the study.
4.Patients in whom it has obtained written informed consent
for participation in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Patients younger than 18 years.
2. Patients who have been treated with cinacalcet 3 months prior to initiation of study.
3.Serum calcium levels less than 8.4 mg / dl at the time of inclusion
4.Functioning renal transplant patients
5.Gestation or pregnancy desire
6.Women of childbearing age, sexually active and who do not follow a contraception method acceptable to the researcher.
7.Nursing

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate stability or improvement in stiffness parameters and vascular calcification in patients with chronic kidney disease (CKD) stage 5 and hyperparathyroidism secondary after 1 year, added Cinacalcet to conventional treatment versus patients in conventional treatment (vitamin D + chelating phosphorus);Secondary Objective: Evaluate the progression of mineral metabolism parameters in these patients.;Primary end point(s): Improvement or stabilization of the vascular stiffness defined by:<br>1) Stabilization or improvement of the speed wave of pulsar mesured by VOP<br>2) Stabilization or improvement in the score of vascular calcification mesured by CTA<br>3) Improvement or stabilization of subclinical atherosclerosis measured from the intimate grosor Media (GIM) and the identifications of atheroma.;Timepoint(s) of evaluation of this end point: 1 year

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes, in Analytical Parameters: <br>-Calcium, <br>-Phosphorus, <br>-Calcium / phosphorus, <br>-PTH;Timepoint(s) of evaluation of this end point: 1 year