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 sujetos 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 (Altos niveles de la hormona paratiroidea) secundario con 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 | 16.1 |
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 | 16.1 |
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 |
|
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 velcalcetide in the treatment of SHPT in subjects with CKD on hemodialysis. |
Describir la seguridad y la tolerabilidad a largo plazo de velcalcetide en el tratamiento del HPTS en sujetos con IRC sometidos a hemodiálisis. |
|
E.2.2 | Secondary objectives of the trial |
To characterize intact parathyroid hormone (iPTH), total serum corrected calcium (cCa), and serum phosphorous (P) values in the treatment of SHPT in subjects with CKD on hemodialysis, who are being treated with velcalcetide. |
Describir los valores de hormona paratiroidea intacta (iPTH), calcio sérico total corregido por albúmina (Cac) y fósforo sérico (P) en el tratamiento del HPTS en sujetos con IRC sometidos a hemodiálisis, que están siendo tratados con velcalcetide. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
101.Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
102. Subject has completed treatment in Study 20120231 (also known as KAI-4169-008) or Study 20120360, or has participated in Study 20120334 (also known as KAI-4169-005-01).
103. Female subjects who are:
-post menopausal (post menopausal is defined as no menses for the previous 1 year and over the age of 50 years)
-surgically sterilized
-have a medical condition that prevents pregnancy
-remain abstinent
-or are willing to use highly effective contraception during the study and for 3 months after the last dose
Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 2 weeks prior to the first dose of velcalcetide in the current study.
104. Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months.
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-El sujeto ha proporcionado su consentimiento informado antes de iniciar cualquier procedimiento/actividad específico del estudio.
-El sujeto ha completado el tratamiento en el estudio 20120231 (también denominado KAI-4169-008) o en el estudio 20120360, o ha participado en el estudio 20120334 (también denominado KAI-4169-005-01).
-Las sujetos femeninos que:
Sean posmenopáusicas (posmenopáusica se define como la ausencia de menstruación durante el año precedente y mayores de 50 años).
Se hayan sometido a esterilización quirúrgica.
Tengan un trastorno médico que impida el embarazo.
No mantengan relaciones sexuales
O que estén dispuestas a utilizar un método anticonceptivo altamente eficaz durante el estudio y durante 3 meses después de la última dosis.
-Las mujeres en edad fértil (MEF) deberán obtener una prueba negativa de embarazo en suero durante las 2 semanas anteriores a la primera dosis de velcalcetide en el estudio actual.
-El sujeto debe estar recibiendo hemodiálisis 3 o 4 veces por semana durante como mínimo 3 meses.
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E.4 | Principal exclusion criteria |
201. Currently receiving treatment in another investigational device or drug study (other than in one of the designated parent studies).
202. Other investigational procedures while participating in this study are excluded.
203. Subject has known sensitivity to any of the products or components to be administered during dosing.
204. Subject has been prescribed cinacalcet by the primary nephrologist between the conclusion of the parent study and the start of dosing with velcalcetide in the current study.
205. Subject has any illness that, in the judgment of the Investigator, might confound the results of the study or pose additional risk to the subject.
206. Subject is receiving dialysis prescription dialysate calcium concentration < 2.25 mEq/L
207. Subject is pregnant or nursing.
208. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the judgment of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
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-Estar recibiendo actualmente tratamiento en otro estudio de un fármaco o dispositivo en investigación (aparte del indicado en los estudios originales designados).
-Están excluidos 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 nefrólogo principal ha prescrito cinacalcet al sujeto entre la conclusión del estudio original y el inicio de la administración de la dosis con velcalcetide en el estudio actual.
-El sujeto tiene cualquier enfermedad que, según el criterio del investigador, puede confundir los resultados del estudio o suponer un riesgo adicional para el sujeto.
-El sujeto recibe una concentración de calcio en el dializado prescrita para la diálisis < 2,25 mEq/L.
-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, según el criterio del investigador, supongan un riesgo para la seguridad del sujeto o puedan interferir en la evaluación, los procedimientos o la finalización del estudio.
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E.5 End points |
E.5.1 | Primary end point(s) |
Subject incidence of adverse events reported throughout the study |
Incidencia en los sujetos de los acontecimientos adversos notificados a lo largo del estudio. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the study |
Durante todo el estudio |
|
E.5.2 | Secondary end point(s) |
• Occurrence of iPTH value at Months 6, 12, and 18 which is within 2x to 9x the upper limit of normal (ULN) for the assay used
• Occurrence of P ≤ 4.6 mg/dL at Months 6, 12, and 18
|
-Aparición en los meses 6, 12 y 18 de valores de la iPTH entre 2 y 9 veces el límite superior de la normalidad (LSN) para el análisis utilizado.
-Aparición en los meses 6, 12 y 18 de valores de P ≤ 4,6 mg/dL.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At 6, 12 & 18 months. |
A los 6, 12 y 18 meses |
|
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 | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 17 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 95 |
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 |
Belgium |
Denmark |
France |
Greece |
Italy |
Austria |
Netherlands |
Portugal |
Sweden |
Czech Republic |
Estonia |
Germany |
Hungary |
Latvia |
Lithuania |
Spain |
Israel |
Mexico |
Poland |
Russian Federation |
Switzerland |
Turkey |
United Kingdom |
|
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, 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 | 6 |
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 | 6 |