Clinical Trials Register

Summary
EudraCT Number:	2013-000192-33
Sponsor's Protocol Code Number:	20120360
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-06-10
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2013-000192-33

A.3

Full title of the trial

A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism

Estudio multicéntrico de dosis múltiples, con dos grupos, control activo, doble ciego y doble enmascarado para comparar la eficacia y la seguridad terapéutica de dosis orales de cinacalcet HCI con dosis intravenosas de AMG 416 en sujetos sometidos a hemodiálisis con hiperparatiroidismo secundario

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Compare therapeutic efficacy and safey of AMG 416 and cinacalcet HCl in hemodialysis subjects with secondary hyperparathyroidism

Para comparar la eficacia y seguridad de AMG 416 y cinacalcet HCI en sujetos sometidos a hemodiálisis con hiperparatiroidismo secundario

A.4.1

Sponsor's protocol code number

20120360

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	KAI Pharmaceuticals, Inc (a subsidiary of Amgen, Inc.)
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Amgen Inc
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Amgen (EUROPE) GmbH
B.5.2	Functional name of contact point	IHQ Medical Info - Clinical Trials
B.5.3	Address:
B.5.3.1	Street Address	Dammstrasse 23, P.O. Box 1557
B.5.3.2	Town/ city	Zug
B.5.3.3	Post code	(CH-)6300
B.5.3.4	Country	Switzerland
B.5.6	E-mail	MedinfoInternational@amgen.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	AMG 416
D.3.2	Product code	AMG 416
D.3.4	Pharmaceutical form	Powder for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent) Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AMG 416
D.3.9.1	CAS number	1334237-71-6
D.3.9.2	Current sponsor code	AMG 416
D.3.9.3	Other descriptive name	n/a
D.3.9.4	EV Substance Code	SUB14950MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Cinacalcet
D.2.1.1.2	Name of the Marketing Authorisation holder	Amgen Inc.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Cinacalcet
D.3.2	Product code	AMG073
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CINACALCET
D.3.9.1	CAS number	226256-56-0
D.3.9.2	Current sponsor code	AMG 073
D.3.9.3	Other descriptive name	na
D.3.9.4	EV Substance Code	SUB25416
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Cinacalcet
D.2.1.1.2	Name of the Marketing Authorisation holder	Amgen Inc.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Cinacalcet
D.3.2	Product code	AMG073
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CINACALCET
D.3.9.1	CAS number	226256-56-0
D.3.9.2	Current sponsor code	AMG 073
D.3.9.3	Other descriptive name	na
D.3.9.4	EV Substance Code	SUB25416
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Cinacalcet
D.2.1.1.2	Name of the Marketing Authorisation holder	Amgen Inc.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Cinacalcet
D.3.2	Product code	AMG073
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CINACALCET
D.3.9.1	CAS number	226256-56-0
D.3.9.2	Current sponsor code	AMG 073
D.3.9.3	Other descriptive name	na
D.3.9.4	EV Substance Code	SUB25416
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	90
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Powder and solution for solution for injection
D.8.4	Route of administration of the placebo	Intravenous bolus use (Noncurrent)
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic Kidney Disease
Secondary Hyperparathyroidism (SHPT)

Enfermedad Renal Crónica
Hiperparatiroidismo Secundario (HPTS)

E.1.1.1

Medical condition in easily understood language

Chronic Kidney Disease
Secondary Hyperparathyroidism (SHPT)

Enfermedad Renal Crónica
Hiperparatiroidismo Secundario (HPTS)

E.1.1.2

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10064848
E.1.2	Term	Chronic kidney disease
E.1.2	System Organ Class	100000004857

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
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.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Demonstrate that treatment with AMG 416 is not inferior to treatment with cinacalcet for lowering plasma intact parathyroid hormone (PTH) levels by > 30% from baseline among subjects with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

Demostrar que el tratamiento con AMG 416 no es inferior al tratamiento con cinacalcet para reducir en > 30% los niveles séricos de hormona paratiroidea (PTH) intacta, con respecto al valor basal, entre sujetos con ERC e HPTS que necesitan tratamiento con hemodiálisis

E.2.2

Secondary objectives of the trial

Assess whether treatment with AMG 416 is superior to treatment with cinacalcet as measured by the mean days of vomiting or nausea per week, proportion of subjects with > 50% decrease in plasma PTH from baseline, change from baseline in albumin corrected calcium concentration (cCa), mean pre-dialysis serum phosphorous (P), mean severity of nausea, and mean episodes of vomiting. Information about nausea and vomiting will be collected via a patient reported outcome.

Evaluar si el tratamiento con AMG 416 es superior al tratamiento con cinacalcet medido mediante la media de días con vómitos o náuseas por semana, la proporción de sujetos con reducción de la PTH sérica > 50% con respecto al valor basal, el cambio respecto al valor basal de la concentración de calcio corregido por albúmina (Cac), la media de fósforo (P) sérico anterior a la diálisis, la media de la severidad de las náuseas y la media de episodios de vómitos por semana. Se recogerá información sobre náuseas y vómitos por medio de un instrumento de resultados notificados por el paciente

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Subject has provided informed consent.
- 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.
- Subject is 18 years of age or older.
- Female subject must be willing to use highly effective contraception during the study and for 3 months after the last dose of investigational product (unless postmenopausal or surgically sterilized).
- Male subject must be willing to use highly effective contraception during the
- Subject must be receiving maintenance hemodialysis 3 times weekly for at least 3 months, with adequate hemodialysis with a delivered Kt/V ? 1.2 or urea reduction ratio (URR) ? 65% within 4 weeks prior to screening laboratory assessments.
- Dialysate calcium concentration must be ? 2.5 mEq/L and stable for at least 3 months prior to screening laboratory assessments, and must remain ? 2.5 mEq/L for the duration of the study.
- Subject must have SHPT as defined by having 2 consecutive central laboratory screening predialysis plasma PTH values > 600 pg/mL, measured on separate days within 4 weeks prior to randomization.
? For a subject currently receiving vitamin D sterols, the vitamin D dose must have been constant with no change for a minimum of 4 weeks prior to screening laboratory assessments and until randomization.
- Subject must have 2 consecutive screening predialysis serum cCa laboratory values measured on separate days within 4 weeks prior to randomization, and the results on both days must be ? 8.3 mg/dL.
- A subject receiving calcium supplements must be on a stable dose for at least 2 weeks prior to screening laboratory assessments and until randomization.
- A subject receiving phosphate binders must be on a stable dose for at least 2 weeks prior to screening laboratory assessments and dose should remain stable throughout the study except as noted in the protocol.

- El sujeto ha dado su consentimiento informado.
- El representante legal autorizado del sujeto proporciona el consentimiento informado cuando el sujeto presenta cualquier tipo de enfermedad que, según la opinión del investigador, puede comprometer su capacidad para proporcionar el consentimiento informado por escrito.
- El sujeto tiene 18 años o más.
Las mujeres deben usar métodos anticonceptivos altamente eficaces durante el estudio y los 3 meses posteriores a la última dosis de producto en investigación ( a menos que sean postmenopáusica o esterilizadas quirúrgicamente)
Los hombres deben usar métodos anticonceptivos altamente eficaces durante el estudio y los 9 días posteriors a la última dosis del product en investigación.
El sujeto debe estar recibiendo hemodiálisis de mantenimiento 3 veces a la semana durante al menos 3 meses y recibir una hemodiálisis adecuada con Kt/V ? 1,2 o una tasa de reducción de urea (TRU) ? 65% durante las 4 semanas anteriores a las evaluaciones de laboratorio de selección.
-La concentración de calcio en el dializado debe ser ? 2,5 mEq/L y estable durante al menos 3 meses antes de las evaluaciones analíticas de selección y debe mantenerse ? 2,5 mEq/L durante el estudio.
- El sujeto debe tener HPTS definido por 2 valores de selección consecutivos de la PTH sérica previa a la diálisis > 600 pg/mL, determinados en el laboratorio central y medidos en días distintos en las 4 semanas previas a la aleatorización.
?En un sujeto que esté recibiendo esteroles de la vitamina D, la dosis de vitamina D debe haber sido constante sin cambios durante al menos 4 semanas antes de las determinaciones de laboratorio para la selección y hasta la aleatorización.
-El sujeto debe tener en la selección 2 valores analíticos consecutivos de Cac sérico previos a la diálisis medidos en días distintos durante las 4 semanas anteriores a la aleatorización y cuyo resultado en ambos días sea ? 8,3 mg/dL.
- En un sujeto que recibe suplementos de calcio la dosis debe ser estable durante al menos 2 semanas antes de las evaluaciones analíticas de selección y hasta la aleatorización.
- En un sujeto que recibe quelantes del fosfato la dosis debe ser estable durante al menos 2 semanas antes de las evaluaciones analíticas de selección, y la dosis debe mantenerse estable durante todo el estudio excepto cuando se menciona en el protocolo.

E.4

Principal exclusion criteria

- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
- Currently receiving other investigational procedures while participating in this study are excluded.
- Subject has participated in a prior clinical trial of AMG 416 (also known as KAI-4169).
- Subject has received cinacalcet during the 3 months prior to the first screening laboratory assessments.
- Subject has known sensitivity to any of the products or components of either cinacalcet or AMG 416 to be administered during dosing.
- Subject has entered this study previously.
- Anticipated or scheduled parathyroidectomy during the study period.
- Subject has received a parathyroidectomy within 6 months prior to dosing.
- Anticipated or scheduled kidney transplant during the study period.
- 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.
- Malignancy within the last 5 years (except non-melanoma skin cancers or cervical carcinoma in situ).
- Subject is pregnant or nursing.
- Subject has a history of symptomatic ventricular dysrhythmias or Torsades de Pointes.
- Subject has a history of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening.
- Subject has clinically significant abnormalities on prestudy clinical examination or central laboratory tests during the 4 weeks prior to randomization according to the Investigator including but not limited to the following:
? serum albumin < 2.5 g/dL
? serum magnesium < 1.5 mg/dL
? serum transaminase (alanine transaminase [ALT] or Serum glutamic pyruvic transaminase [SGPT], aspartate aminotransferase [AST] or serum glutamic oxaloacetic transaminase [SGOT]) > 2.5 times the upper limit of normal (ULN) at screening
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and Investigator?s knowledge.
- 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. This includes a subject who previously received cinacalcet, and in the opinion of the Investigator, is not a good candidate for future cinacalcet treatment.

- Estar recibiendo actualmente tratamiento en otro estudio de un fármaco o dispositivo en investigación o haber transcurrido menos de 30 días desde el fin del tratamiento en otro estudio de un fármaco o dispositivo en investigación.
- Recibiendo actualmente otro procedimiento de investigación mientras se participe en este estudio.
- El sujeto ha participado en un ensayo clínico anterior de AMG 416 (también conocido como KAI-4169).
- El sujeto ha recibido cinacalcet durante los 3 meses anteriores a las primeras evaluaciones analíticas de selección.
- El sujeto presenta una sensibilidad conocida a alguno de los productos o componentes de cinacalcet o AMG 416 que se administrarán durante la dosificación.
- El sujeto ya ha sido incluido anteriormente en este estudio.
- Paratiroidectomía prevista o programada durante el período de estudio.
- El sujeto se ha sometido a una paratiroidectomía durante los 6 meses previos a la administración.
- Trasplante de riñón previsto o programado durante el período de estudio.
- El sujeto tiene un proceso médico inestable según su historia clínica, la exploración física y las pruebas analíticas de rutina, o de lo contrario es inestable a criterio del investigador.
- Neoplasia durante los últimos 5 años (excepto cánceres de piel no melanomatosos o carcinoma cervical in situ).
- La paciente está embarazada o en período de lactancia.
- El sujeto tiene antecedentes de disritmias ventriculares sintomáticas o torsades des pointes.
- El sujeto tiene antecedentes de infarto de miocardio, angioplastia coronaria o injerto de derivación de arteria coronaria durante los últimos 6 meses anteriores a la selección.
- El sujeto sufre anomalías clínicamente significativas en la exploración clínica previa al estudio o en las pruebas del laboratorio central durante las 4 semanas previas a la aleatorización según el investigador que incluyen, aunque sin limitación:
?albúmina sérica < 3,0g/dL
?magnesio sérico < 1,5 mg/dL
?transaminasa sérica (alanina transaminasa [ALT] o transaminasa piruvato-glutamato sérica [SGPT], aspartato aminotransferasa [AST] o transaminasa glutámico-oxalacética sérica [SGOT] > 2,5 veces el límite superior de la normalidad (LSN) en el momento de la selección.
-Según informan el sujeto y el investigador, es posible que el sujeto no esté disponible para completar todas las visitas o procedimientos del estudio requeridos por el protocolo y/o cumplir todos los procedimientos del estudio.
-Antecedentes o signos de cualquier otro trastorno, afección o enfermedad clínicamente significativa (a excepción de las que se indican arriba) que, en opinión del investigador o del médico de Amgen, si se consultan, puedan suponer un riesgo para la seguridad del sujeto o interferir en la evaluación, los procedimientos o la finalización del estudio. Esto incluye a un sujeto que ya ha recibido cinacalcet anteriormente y, según la opinión del investigador, no es un buen candidato para el futuro tratamiento con cinacalcet.

E.5 End points

E.5.1

Primary end point(s)

Achievement of a > 30% reduction from baseline in mean pre-dialysis serum plasma PTH level
during the efficacy assessment phase (EAP).

Alcanzar una reducción > 30% respecto al valor basal en el nivel medio de PTH sérica previa a la diálisis durante la fase de evaluación de la eficacia (FVE) del estudio (la FVE se define como el período de la semana 20 a la 27).

E.5.1.1

Timepoint(s) of evaluation of this end point

At day 20, 22, 24, 26 and 27

En los días 20, 22, 24, 26 y 27

E.5.2

Secondary end point(s)

- mean number of days of vomiting or nausea per week in the first 8 weeks
- achievement of a > 50% reduction from baseline in mean pre-dialysis plasma PTH during the EAP

- Número medio de días con vómitos o náuseas por semana durante las 8 primeras semanas.
- Alcanzar una reducción > 50% respecto al valor basal en la PTH sérica previa a la diálisis durante la FVE.

E.5.2.1

Timepoint(s) of evaluation of this end point

- Information about nausea and vomiting will be collected via a patient reported outcome instrument.
- At day 20, 22, 24, 26 and 27

La información sobre naúseas y vómitos será recopilada vía los pacientes mediante una herramienta de recogida de resultados
- En los días 20, 22, 24, 26 y 27

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

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

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

Denmark

Estonia

France

Germany

Greece

Hungary

Italy

Latvia

Lithuania

Poland

Portugal

Russian Federation

Spain

Sweden

Switzerland

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

The end of the entire study for all subjects occurs at the primary completion date, which is defined as the time when the last subject completes their end of study visit.

El fin de todo el estudio para todos los sujetos tiene lugar en la fecha de finalización principal, que se define como el momento en el cual el último sujeto completa la visita de fin del estudio.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

600

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

342

F.4.2.2

In the whole clinical trial

600

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Plans for treatment of care after the subject has ended participation are not different from the expected normal treatment for this condition.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	ERT
G.4.3.4	Network Country	United States

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-07-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-07-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-12-24

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IMP with orphan designation in the indication
Orphan Designation Number:
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