Bone's disorders and mineral metabolism and vascular involvement MedDRA version: 16.1 Level: PT Classification code 10051753 Term: Vascular calcification System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: Cinacalcet
Pharmaceutical Form: Tablet
Trade Name: Rocaltrol
Pharmaceutical Form: Coated tablet
Trade Name: Fosrenol
Pharmaceutical Form: Powder for oral solution
Sponsors
Hospital Universitari de Girona Dr.Josep Trueta
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 1) Stabilization or improvement of the speed wave of pulsar mesured by VOP 2) Stabilization or improvement in the score of vascular calcification mesured by CTA 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes, in Analytical Parameters: -Calcium, -Phosphorus, -Calcium / phosphorus, -PTH;Timepoint(s) of evaluation of this end point: 1 year | — |
Countries
Spain
Contacts
Public ContactCristina Martinez
Hospital Universitari de Girona Dr.Josep Trueta
Outcome results
None listed