E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Secondary hyperparathyroidism in subjects with chronic kidney disease |
Hiperparatiroidismo secundario en pacientes con insuficiencia renal crónica |
|
E.1.1.1 | Medical condition in easily understood language |
Hyperparathyroidism (high levels of parathyroid hormone) secondary to chronic kidney disease |
Hiperparatiroidismo (niveles elevados de hormona paratiroidea) secundario a la insuficiencia renal crónica |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Symptoms and general pathology [C23] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020708 |
E.1.2 | Term | Hyperparathyroidism secondary |
E.1.2 | System Organ Class | 10014698 - Endocrine disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020706 |
E.1.2 | Term | Hyperparathyroidism NOS |
E.1.2 | System Organ Class | 10014698 - Endocrine disorders |
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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 |
To characterize the long-term safety and tolerability of AMG 416 in the treatment of SHPT in subjects with chronic kidney disease on hemodialysis. |
Caracterizar la seguridad y la tolerabilidad a largo plazo de AMG 416 en el tratamiento del HPTS en pacientes con insuficiencia renal crónica sometidos a hemodiálisis |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives are to characterize the long-term efficacy of AMG 416 on intact parathyroid hormone (iPTH), corrected calcium (cCa), corrected calcium-phosphorus product (cCa x P), and phosphorus |
Los objetivos secundarios son caracterizar la eficacia a largo plazo de AMG 416 sobre la hormona paratiroidea intacta (PTHi), la calcemia corregida (Cac), el producto entre la calcemia corregida y el fósforo (Cac x P) y el fósforo. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? Subject understands the study procedures and agrees to participate in the study by giving written informed consent. ? Subject must complete the treatment and follow-up period, or have been discontinued for rising iPTH, from an AMG 416 phase 3 parent study prior to the start of dosing in this study. ? Subject agrees to not participate in another study of an investigational agent during the study. ? Dialysis prescription dialysate calcium concentration must be ? 2.25 mEq/L. ? Female subject who is post menopausal (post menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, has a medical condition that prevents pregnancy, remains abstinent, or is willing to use highly effective contraception during the study and for 3 months after the last dose. Women of child-bearing potential must have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416. ? Male subject is willing to use highly effective contraception when sexually active and will not donate sperm during the treatment phase and for 3 months after the last dose. ? Subject?s legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent. |
? El sujeto comprende los procedimientos del estudio y acepta participar en él dando su consentimiento informado por escrito. ? Antes de empezar el tratamiento del estudio, el sujeto habrá completado el tratamiento y el período de seguimiento o se habrá retirado de uno de los estudios originales de AMG416 Fase III debido a una elevación de la PTHi. ? El sujeto se compromete a no participar durante el estudio en ningún otro estudio de un fármaco en investigación. ? La concentración de calcio en el líquido de diálisis prescrita para la diálisis debe ser ? 2,25 mEq/l. ? Mujeres posmenopáusicas (con ausencia de menstruación durante el año precedente y mayores de 50 años), sometidas a esterilización quirúrgica, con un trastorno médico que impida el embarazo, que no mantienen relaciones sexuales o que están dispuestas a utilizar métodos anticonceptivos sumamente eficaces durante el estudio y hasta tres meses después de la última dosis. Las mujeres en edad fértil deben tener un resultado negativo en la prueba de embarazo en suero en las dos semanas previas a la primera dosis de AMG 416. ? Los varones deben estar dispuestos a utilizar un método anticonceptivo de gran eficacia cuando mantengan relaciones sexuales y no donarán semen durante la fase de tratamiento y hasta tres meses después de la última dosis. ? El representante legal del sujeto ha otorgado su consentimiento informado en el caso de que éste presente un trastorno de cualquier tipo que, en opinión del investigador, pueda afectar a su capacidad para dar el consentimiento informado por escrito. |
|
E.4 | Principal exclusion criteria |
? Currently receiving treatment in another investigational device or drug study. ? Currently receiving other investigational procedures while participating in this study. ? Subject has known sensitivity to any of the products or components to be administered during dosing. ? Subject has received cinacalcet between the last dose of investigational product in the parent study (20120229 or 20120230) and the start of dosing with AMG 416 in the current study. ? Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator. ? Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject. ? Subject has a serious concurrent medical condition (eg, malignancy) likely to result in death during the next 12 months. ? Subject is pregnant or nursing. ? History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. |
? Actualmente en tratamiento en otro estudio de un dispositivo o fármaco en investigación. ? Estar sometiéndose a otros procedimientos experimentales durante la participación en este estudio. ? El sujeto tiene sensibilidad conocida a alguno de los productos o componentes que se vayan a administrar durante el tratamiento del estudio. ? El sujeto ha recibido cinacalcet entre la última dosis del producto en investigación en el estudio original (20120229 0 20120230) y el comienzo de la administración de AMG 416 en el presente estudio. ? El sujeto padece una enfermedad inestable de acuerdo con la historia clínica, la exploración física y los análisis clínicos habituales, o se encuentra inestable en opinión del investigador. ? El sujeto tiene antecedentes de cualquier enfermedad que, en opinión del investigador, puede confundir los resultados del estudio o suponer un riesgo adicional para el sujeto. ? El sujeto tiene una enfermedad concomitante grave (por ejemplo, neoplasia maligna) que probablemente cause la muerte en los próximos 12 meses. ? La paciente está embarazada o en período de lactancia. ? Antecedentes o signos de cualquier anomalía, trastorno o enfermedad de importancia clínica (a excepción de los descritos anteriormente) que, en opinión del investigador o del médico de Amgen, en el caso de que se le consulte, suponga un riesgo para la seguridad del sujeto o pueda interferir en la evaluación, los procedimientos o la compleción del estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
? nature, frequency, severity, and relationship to treatment of all adverse events reported throughout the study ? vital signs and changes in laboratory parameters, including clinical chemistry ? evaluation of antibody formation to AMG 416 |
? naturaleza, frecuencia, intensidad y relación con el tratamiento de todos los acontecimientos adversos notificados durante el estudio. ? constantes vitales y alteraciones en los parámetros analíticos, incluida la bioquímica clínica. ? evaluación de la formación de anticuerpos anti-AMG 416. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the efficacy assessment phase |
Durante la fase de valoración de la eficacia |
|
E.5.2 | Secondary end point(s) |
? proportion of subjects with > 30% reduction from baseline in predialysis iPTH during the efficacy assessment phase (EAP) and the EAP at 12 months (EAP12) ? proportion of subjects with predialysis iPTH ? 300 pg/mL during the EAP and EAP12 ? percent change from baseline in predialysis iPTH during the EAP and EAP12 ? percent change from baseline in predialysis serum cCa during the EAP and EAP12 ? percent change from baseline in predialysis cCa x P during the EAP and EAP12 ? percent change from baseline in predialysis serum phosphorus during the EAP and EAP12 |
? porcentaje de sujetos que presentan, durante la fase de evaluación de la eficacia (FEE) y la FEE a los 12 meses (FEE12), una reducción de la concentración de PTHi anterior a la diálisis mayor del 30% con respecto al período basal. ? porcentaje de sujetos con una concentración de PTHi anterior a la diálisis inferior o igual a 300 pg/ml durante la FEE y la FEE12. ? variación porcentual, con respecto al valor basal, de la PTHi anterior a la diálisis durante la FEE y la FEE12. ? variación porcentual, con respecto al valor basal, del Cac sérico anterior a la diálisis durante la FEE y la FEE12. ? variación porcentual, con respecto al valor basal, del producto Cac x P anterior a la diálisis durante la FEE y la FEE12. ? variación porcentual, con respecto al valor basal, del fósforo sérico anterior a la diálisis durante la FEE y la FEE12. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Throughout the efficacy assessment phase |
Durante la fase de valoración de la eficacia |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 115 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Austria |
Belgium |
Canada |
Czech Republic |
France |
Germany |
Hungary |
Israel |
Italy |
Netherlands |
Poland |
Russian Federation |
Spain |
Sweden |
United Kingdom |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
LVLS |
Última visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |