| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Anaemia of Chronic Kidney Disease |
| Anemia en nefropatía crónica |
|
| E.1.1.1 | Medical condition in easily understood language |
| A decrease in the number of red blood cells as a result of chronic kidney disease |
| Descenso en el número de glóbulos rojos, como resultado de Nefropatía crónica |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10058123 |
| E.1.2 | Term | Renal anaemia |
| E.1.2 | System Organ Class | 100000004851 |
|
| 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 |
1) To evaluate efficacy of treatment with BAY 85-3934 compared with darbepoetin alfa as measured by change from baseline to post-baseline time points in haemoglobin (Hb) levels.
2) To evaluate safety and tolerability of treatment with BAY 85-3934 compared with darbepoetin by events of special interest, adjudicated serious adverse events (SAEs), and SAEs. |
1) Evaluar la eficacia del tratamiento con BAY 85-3934 comparado con darbepoetina alfa (denominado, en lo sucesivo, darbepoetina) medida por el cambio en los niveles de hemoglobina (Hb) desde el inicio del tratamiento hasta los puntos temporales posteriores.
2) Evaluar la seguridad y tolerabilidad del tratamiento con BAY 85-3934 en comparación con darbepoetina por episodios de interés especial, acontecimientos adversos graves (AAG) adjudicados y AAG |
|
| E.2.2 | Secondary objectives of the trial |
1) To evaluate other efficacy variables of treatment with BAY 85-3934 compared with darbepoetin.
2) To evaluate other safety variables of treatment with BAY 85-3934 compared with darbepoetin |
1) Evaluar otras variables de la eficacia del tratamiento con
BAY 85-3934 en comparación con darbepoetina
2) Evaluar otras variables de la seguridad del tratamiento con
BAY 85-3934 en comparación con darbepoetina |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
- Men who agree to use adequate contraception when sexually active or women without childbearing potential
- Not on dialysis at study entry
- Serum ferritin levels >=100 ug/L and < 1000 ug/L and transferrin saturation >= 20%
- Inclusion criteria for inclusion into the haemoglobin (Hb) Stabilization (HbS) Phase: Requires Hb stabilization (at 10.0 to 12.0 g/dL for a minimum of 4 weeks) as follows: Received BAY 85-3934 and reached a stopping event in Study 15141 or Received placebo and reached a stopping event in Study 15141 or Completed 16 weeks of treatment with placebo in Study 15141 and was re-assessed at 4 weeks after end of study as eligible for Study 15653 (this study)
- Inclusion criteria for inclusion into the Main Phase: Mean Hb concentration of 10.0 to 12.0 g/dL |
-Hombres que aceptan utilizar un método anticonceptivo adecuado si son sexualmente activos o mujeres que no pueden quedar embarazadas
-Pacientes que no están recibiendo tratamiento con diálisis en la actualidad.
-Concentraciones de ferritina sérica >= 100 ug/l y < 1000 ug/l y saturación de transferrina >= 20 %
-Criterios de inclusión para participar en la fase de estabilización del nivel de Hb (HbS):
-Requiere la estabilización del nivel de Hb (entre 10,0 y 12,0 g/dl durante un período mínimo de 4 semanas), según se indica a continuación:
- Haber recibido BAY 853934 y presentado un episodio de interrupción en el estudio 15141 o Haber recibido placebo y presentado un episodio de interrupción en el estudio 15141 o Haber completado 16 semanas de tratamiento con placebo en el estudio 15141 y haber sido evaluado de nuevo 4 semanas después del final del estudio como idóneo para el estudio 15643 (este estudio).
-criterios de inclusión en la fase principal: Concentración media de Hb de 10,0 a 12,0 g/dl. |
|
| E.4 | Principal exclusion criteria |
- A scheduled kidney transplant or any other organ transplant within the next 6 months (being on a waiting list does not exclude the subject)
- Red blood cell (RBC) containing transfusion within the 8 weeks before baseline
- Phosphodiesterase type 5 (PDE5) inhibitor (e.g., sildenafil, vardenafil, tadalafil) or nitrates
- Sustained, poorly controlled arterial hypertension or hypotension at baseline, defined as blood pressure >=180/110 mmHg or systolic blood pressure < 95 mmHg, respectively
- Severe rhythm or conduction disorders (e.g., heart rate [HR] < 50 or > 110 bpm, atrial fibrillation or flutter, prolonged QT > 500 msec, second or third degree atrioventricular [AV] block)
- New York Heart Association Class III or IV congestive heart failure
- Severe hepatic insufficiency (defined as alanine aminotransferase [ALT], aspartate aminotransferase [AST], or gamma glutamyl transferase [GGT] > 3 x the upper limit of normal [ULN], total bilirubin > 2 mg/dL, or Child Pugh B or C) or active hepatitis, in the investigator's opinion
- An ongoing serious adverse event (SAE) from Study 15141 or Study 15261 that is assessed as related to study drug |
-Trasplante renal programado o cualquier otro trasplante orgánico en los 6 meses siguientes (la inclusión en una lista de espera no excluye al paciente).
-Transfusiones con eritrocitos en las 8 semanas anteriores al inicio
-Inhibidores de PDE5 (por ejemplo, sildenafilo, vardenafilo, tadalafilo) o nitratos
-Hipertensión o hipotensión arterial mantenida y mal controlada antes del inicio del tratamiento del estudio, definida como una PA ? 180/110 mmHg o una tensión sistólica < 95 mmHg, respectivamente.
-Trastornos graves del ritmo o la conducción (por ejemplo, FC inferior a 50 o mayor de 110 lpm, fibrilación o aleteo auricular, prolongación del intervalo QT > 500 ms, bloqueo auriculoventricular [AV] de segundo o tercer grado).
-Insuficiencia cardíaca congestiva de las clases III o IV de la New York Heart Association (NYHA).
-Insuficiencia hepática grave (definida como alanina aminotransferasa [ALT], aspartato aminotransferasa [AST] o ? glutamiltransferasa [GGT] más de 3 veces el límite superior de la normalidad [LSN], bilirrubina total > 2 mg/dl o una clasificación de Child-Pugh B o C), o hepatitis activa, según la opinión del investigador.
-Un AAG en curso de los estudios 15141 o 15261 que se evalúe relacionado con el fármaco del estudio. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1) Change in local laboratory haemoglobin level from baseline
2) Number of participants with serious adverse events as a measure of safety and tolerability |
1) Cambio en el nivel de Hb según el laboratorio local respecto al nivel de Hb inicial.
2) Número de participantes con Acontecimientos adversos graves como medida de seguridad y tolerabilidad. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1) Baseline up to 36 months
2) Up to 36 months |
1) Basal hasta 36 meses
2) Hasta 36 meses. |
|
| E.5.2 | Secondary end point(s) |
1) Maintenance in haemoglobin target range (10.0 to 12.0 g/dL)
2) Treatment exposure
3) Number of subjects requiring titration of dose
4) Change of reticulocyte count from baseline of this study
5) Change of reticulocyte count from baseline of study 15141 or 15261
6) Change of red blood cell count from baseline of this study
7) Change of red blood cell count from baseline of study 15141 or 15261
8) Change of hematocrit from baseline of this study
9) Change of hematocrit from baseline of study 15141 or 15261
10) Change of central laboratory haemoglobin level from baseline of this study
11) Change of central laboratory haemoglobin level from baseline of study 15141 or 15261 |
1) Media de las concentraciones de Hb en el intervalo objetivo (de 10,0 a 12,0 g/dl)
2) Exposición al tratamiento.
3) Número de sujetos que requieren un ajuste de la dosis
4) Cambio en el recuento de reticulocitos respecto al valor inicial en este estudio.
5) Cambio en el recuento de reticulocitos respecto al valor inicial en estudio 15141 o 15261.
6) Cambio en el recuento de eritrocitos respecto al valor inicial en este estudio.
7) Cambio en el recuento de eritrocitos respecto al valor inicial en en estudio 15141 o 15261.
8) Cambio en Hematocritos respecto al valor inicial de este estudio.
9) Cambio en Hematocritos respecto al valor inicial en estudio 15141 o 15261.
10) Cambio en el Nivel de Hb según el laboratorio central, respecto al valor inicial en este estudio
11) Cambio en el Nivel de Hb según el laboratorio central, respecto al valor inicial en del estudio 15141 o 15261. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1-3) Up to 36 months
4-11) Baseline up to 36 months |
1-3) hasta 36 meses.
4-11) Basal hasta 36 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 | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| 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 | Yes |
| 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) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| 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 | 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 | 6 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 28 |
| 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 |
| Bulgaria |
| Germany |
| Hungary |
| Italy |
| Japan |
| Romania |
| Korea, Republic of |
| Spain |
| 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 del último paciente. |
|
| 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 | 8 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 3 |
| E.8.9.2 | In all countries concerned by the trial months | 9 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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