E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bone's disorders and mineral metabolism and vascular involvement |
trastornos del metabolismo óseo y mineral y la afectación vascular |
|
E.1.1.1 | Medical condition in easily understood language |
Bone's disorders and mineral metabolism and vascular involvement |
trastornos del metabolismo óseo y mineral y la afectación vascular |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051753 |
E.1.2 | Term | Vascular calcification |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
Evaluar la estabilidad o mejoría en los parámetros de rigidez y calcificación vascular en pacientes con enfermedad renal crónica (IRC) estadío 5 e hiperparatiroidismo secundario después de 1 año, al añadir Cinacalcet al tratamiento convencional versus mantener tratamiento convencional (vitamina D+ quelantes fósforo) |
|
E.2.2 | Secondary objectives of the trial |
Evaluate the progression of mineral metabolism parameters in these patients. |
Evaluar la progresión de los parámetros de metabolismo fosfocálcico en estos pacientes. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
1. Pacientes de ambos sexos con edad superior o igual a 18 años. 2. Pacientes adultos y afectos de insuficiencia renal crónica V y un tiempo inferior a 1 año en tratamiento sustitutivo renal. 3. Pacientes con hiperparatiroidismo secundario con: PTHi > 150 pg/ml antes de la inclusión en el estudio. 4. Pacientes en los que se haya obtenido el consentimiento informado por escrito para la participación en el estudio |
|
E.4 | Principal 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 |
1. Pacientes con edad inferior a 18 años. 2. Pacientes que hayan recibido tratamiento con cinacalcet 3 meses anteriores al inicio del tratamiento. 3. Calcemia sérica inferior a 8.4 mg/dl en el momento de la inclusión 4. Pacientes con trasplante renal funcionante 5. Gestación o deseo de gestación 6. Mujer en edad fértil, con vida sexual activa, que no siga un método anticonceptivo considerado aceptable por el investigador. 7. Lactancia |
|
E.5 End points |
E.5.1 | 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. |
Estabilizacón o mejoria de la rigidez vascular definida por: 1. Estabilización o mejorÍa en la velocidad de onda de pulso medida por VOP 2. Estabilización o mejorÍa en el score de calcificación vascular medida por TAC 3. Estabilización o mejorÍa de arteriosclerosis subclínica a partir de la medición del grosor íntima media (GIM) y la identificación de placas de ateroma. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Changes, in Analytical Parameters: -Calcium, -Phosphorus, -Calcium / phosphorus, -PTH |
Cambios en parámetros analíticos: -Calcio, -Fósforo, -Cacio/Fósforo, -PTH |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
End of trial will be considered when the last patient included in the study will made the last study visit established by protocol |
Se considerará final de ensayo cuando el último paciente incluido realice la última visita establecida en el protocolo |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |