E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic kidney disease |
Enfermedad Renal Crónica |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic kidney disease |
Enfermedad Renal Crónica |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Male diseases of the urinary and reproductive systems [C12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10064848 |
E.1.2 | Term | Chronic kidney disease |
E.1.2 | System Organ Class | 10038359 - Renal and urinary 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 provide continuing open-label treatment with bardoxolone methyl as part of this extended access program while collecting ongoing safety and tolerability data of bardoxolone methyl. |
Proporcionar un tratamiento sin enmascaramiento continuo con bardoxolona metilo como parte de este programa de acceso ampliado, mientras se recaban datos continuos relativos a la seguridad y la tolerabilidad de la bardoxolona metilo |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Treatment-compliant patients who are participating in qualifying ongoing studies and have completed required End-of-Treatment and/or Follow-up visits in a prior clinical study with bardoxolone methyl and who, according to the assessment of the investigator, have a potential positive benefit-risk assessment for participating in the trial. 2. Meets the following eligibility criteria from the prior qualifying study. Patients not meeting the following criteria may be eligible if discussed with the medical monitor prior to enrollment to assess their current clinical status and written approval is obtained: a. eGFR ≥ 30 mL/min/1.73 m^2 at the last on-treatment visit in the prior qualifying study; b. BNP < 200 pg/mL at the last on-treatment visit in the prior qualifying study; c. No occurrence of a cardiovascular serious adverse event in the prior qualifying study. 3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures; 4. Evidence of a personally signed and dated informed consent document (and assent form if necessary) indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any protocol-mandated procedures. |
1. Pacientes que cumplen con el tratamiento, estén participando en estudios de preselección y hayan acudido a las visitas necesarias de fin de tratamiento o seguimiento en un estudio clínico previo con bardoxolona metilo. Asimismo, deben contar, de acuerdo con la evaluación del investigador, con una evaluación potencial positiva de beneficios y riesgos de la participación en el ensayo. 2. Pacientes que cumplan los siguientes criterios de elegibilidad del estudio de cualificación previo. Los pacientes que no cumplan los siguientes criterios pueden ser aptos. Su caso se debe examinar con el monitor médico antes de la incorporación al estudio, para evaluar su estado clínico actual y obtenerse la aprobación por escrito: a. eGFR ≥ 30 ml/min/1,73 m2 en la última visita bajo tratamiento del estudio de cualificación previo; b. BNP < 200 pg/ml en la última visita bajo tratamiento del estudio de cualificación previo; c. Ausencia de acontecimientos adversos graves cardiovasculares en el estudio de cualificación previo. 3. Paciente dispuesto y en condiciones de cumplir las visitas programadas, el plan terapéutico, las pruebas de laboratorio y otros procedimientos del estudio; 4. Existencia de un documento de consentimiento informado firmado personalmente y fechado (y formulario de asentimiento si es necesario), que indique que se ha informado al paciente (o un representante legalmente aceptable) de todos los aspectos pertinentes del estudio, antes de iniciar cualquier procedimiento exigido por el protocolo. |
|
E.4 | Principal exclusion criteria |
1. Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication; 2. Patients who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bardoxolone methyl; 3. Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while taking study drug; 4. Women who are pregnant or breastfeeding; 5. Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason; 6. Known hypersensitivity to any component of the study drug. |
1. Participación en otros estudios clínicos de investigación que impliquen pruebas de productos intervencionistas o usos de los mismos de manera diferente a la aprobada o en indicaciones no aprobadas; 2. Pacientes con AAG en curso de un estudio clínico que el investigador juzgue relacionados con la bardoxolona metilo; 3. Pacientes no dispuestos a practicar métodos aceptables de contracepción (hombres con parejas que pueden quedarse embarazadas y mujeres con posibilidad de quedar embarazadas) mientras toman el fármaco del estudio; 4. Mujeres embarazadas o que dan el pecho; 5. El paciente es, en opinión del investigador, incapaz de cumplir los requisitos del protocolo del estudio o es inadecuado para el estudio por cualquier razón; 6. Hipersensibilidad conocida a algún componente del fármaco del estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Frequency, intensity, and relationship to study drug of adverse events (AEs) and serious adverse events (SAEs), and change from baseline in the following assessments: physical examinations, vital sign measurements, weight, urine albumin to creatinine ratio (UACR), and results of laboratory results. |
Frecuencia, intensidad y relación con el fármaco del estudio de los acontecimientos adversos (AA) y los acontecimientos adversos graves (AAG), y cambios con respecto a los valores iniciales en las siguientes evaluaciones: exámenes físicos, mediciones de signos vitales, peso, cociente de albúmina/creatinina en orina (UACR) y resultados de los análisis de laboratorio. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the clinical trial. |
A lo largo del ensayo clínico. |
|
E.5.2 | Secondary end point(s) |
not applicable |
No aplicable |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
not applicable |
No aplicable |
|
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 | 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) | 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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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 |
France |
Japan |
Spain |
United States |
|
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
|
LVLS |
Ultima visita último sujeto |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 9 |