Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934 (DIALOGUE4)
17 de septiembre de 2019 actualizado por: Bayer
A Randomized, Parallel Group, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Epoetin Alfa / Beta) in the Maintenance Treatment of Subjects With Anemia Associated With Chronic Kidney Disease Who Are on Dialysis and on Treatment With an Erythropoiesis-stimulating Agent in the United States and Japan
Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta as measured by hemoglobin (Hb) levels.
Fixed starting doses of 25, 50,75 and 150 mg of BAY85-3934 titrated at the scheduled dose control visits.
Titration will be based on the subject's Hb response and tolerability of the prior dose.
Planned doses include 15, 25, 50, 75, 100,150 and 200 mg/day
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
201
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
California
-
Azusa, California, Estados Unidos, 91702
-
Long Beach, California, Estados Unidos, 90813
-
Los Angeles, California, Estados Unidos, 90025
-
Lynwood, California, Estados Unidos, 90262
-
Northridge, California, Estados Unidos, 91324
-
San Dimas, California, Estados Unidos, 91773
-
Whittier, California, Estados Unidos, 90606
-
Whittier, California, Estados Unidos, 90602
-
-
Florida
-
New Port Richey, Florida, Estados Unidos, 34652
-
Pembroke Pines, Florida, Estados Unidos, 33028
-
-
Michigan
-
Detroit, Michigan, Estados Unidos, 48236
-
Detroit, Michigan, Estados Unidos, 48202
-
-
Missouri
-
Creve Coeur, Missouri, Estados Unidos, 63141
-
-
New Jersey
-
Eatontown, New Jersey, Estados Unidos, 07724
-
-
New York
-
Brooklyn, New York, Estados Unidos, 11212
-
Buffalo, New York, Estados Unidos, 14215
-
Fresh Meadows, New York, Estados Unidos, 11365
-
-
Ohio
-
Cincinnati, Ohio, Estados Unidos, 45206
-
Toledo, Ohio, Estados Unidos, 43615
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Estados Unidos, 73116
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37212-8150
-
-
Texas
-
Fort Worth, Texas, Estados Unidos, 76104
-
Fort Worth, Texas, Estados Unidos, 76105
-
Fort Worth, Texas, Estados Unidos, 76164
-
Grand Prairie, Texas, Estados Unidos, 75050
-
Houston, Texas, Estados Unidos, 77004
-
Houston, Texas, Estados Unidos, 77091
-
Mansfield, Texas, Estados Unidos, 76063
-
San Antonio, Texas, Estados Unidos, 78229
-
San Antonio, Texas, Estados Unidos, 78215
-
-
-
-
-
Kyoto, Japón, 607-8116
-
Nagano, Japón, 388-8004
-
-
Hokkaido
-
Muroran, Hokkaido, Japón, 050-0083
-
-
Hyogo
-
Himeji, Hyogo, Japón, 670-0947
-
-
Mie
-
Kuwana, Mie, Japón, 511-0061
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- - Eligible subjects will have a diagnosis of anemia associated with CKD(chronic kidney disease).
- Women without childbearing potential
- Male or female subject ≥ 18 years of age with anemia of CKD at screening
- On dialysis, defined as regular long-term hemodialysis, with the same modality of dialysis for ≥ 3 months before randomization
- Dialysis vascular access via native arteriovenous fistula, synthetic graft, long-term catheters, or long-term tunneled catheters
- Treated with epoetin alfa (US or Japan) or epoetin beta (Japan) via intravenous (IV) or subcutaneous (SC) route, on stable dosing defined as a < 50% change from the maximum prescribed weekly dose with no change in the prescribed frequency during the last 8 weeks prior to randomization
- At least one kidney
- Mean screening Hb concentration 9.0 to 11.5 g/dL inclusive (mean of all local laboratory Hb measurements [at least 2 measurements must be taken ≥ 2 days apart] during the 4 week screening period, AND none of the measurements can be < 9.0 g/dL or > 12.0 g /dL
- Serum ferritin levels ≥ 100 μg/L OR transferrin saturation ≥ 20% at screening. Iron substitution is allowed
- Folate and vitamin B12 levels above the lower limit of normal. Supplementation is allowed
- Exclusion Criteria:
- Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
- Hereditary hemoglobinopathies (including, but not limited to, sickle cell disease, beta thalassemia, and thalassemia major) which may be the primary cause of anemia
- Chronic lymphoproliferative diseases
- Any allograft (including renal allograft) in place and on immunosuppressive therapy, or a scheduled kidney transplant within the next 16 weeks (being on a waiting list does not exclude the subject)
- Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease)
- Subjects treated with immuno- or myelosuppressive therapy within 8 weeks prior to randomization: e.g., everolimus, sirolimus, rituximab, azathioprine, mycophenolate mofetil, mycophenolic acid, cyclosporine,methotrexate, and tacrolimus, chemotherapeutic agents and other anticancer agents, and systemic steroids (except inhaled steroids) for 7 days
- RBC-containing transfusion within 8 weeks before randomization
- History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the last 6 months from the initial screening visit
- Sustained, poorly controlled arterial hypertension or hypotension at screening, defined as a mean BP ≥ 180/110 mmHg or systolic BP < 95 mmHg, respectively
- Severe rhythm or conduction disorder (e.g., HR < 50 or > 110 bpm, atrial flutter, prolonged QT >500 msec, second or third degree atrioventricular [AV]block if not treated with a pacemaker)
- 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 > 3 times 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
- A scheduled surgery that may be expected to lead to significant blood loss
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Molidustat (BAY 85-3934)(25mg)
Starting dose of 25 mg of BAY85-3934 as once-daily oral tablets.
Regular titrations at dose control visits.
Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose.
Total treatment time is 16 weeks.
Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.
|
Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
|
|
Experimental: Molidustat (BAY 85-3934)(50mg)
Starting dose of 50 mg of BAY85-3934 as once-daily oral tablets.
Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose.
Total treatment time is 16 weeks.
Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.
|
Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
|
|
Experimental: Molidustat (BAY 85-3934) (75mg)
Starting dose of 75 mg of BAY85-3934 as once-daily oral tablets.
Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose.
Total treatment time is 16 weeks.
Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.,
|
Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
|
|
Experimental: Molidustat (BAY 85-3934) (150mg)
Starting dose of 150 mg of BAY85-3934 as once-daily oral tablets.
Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose.
Total treatment time is 16 weeks.
Planned doses include 15, 25, 50, 75, 100, 150 and 200 mg once daily
|
Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
|
|
Comparador activo: Epoetin alfa/beta
Starting dose at the subject's current weekly dose.
Administered IV or SC 3 times per week.
Doses will be titrated at the scheduled dose control visits according to the local label.
Titration will be based on the subject's Hb response and tolerability of the prior dose.
Epoetin alfa may be administered in either the United States (US) or Japan; epoetin beta will only be administered in Japan.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
Periodo de tiempo: Baseline and weeks 14 to 17
|
Baseline and weeks 14 to 17
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Duration of exposure on each dose level
Periodo de tiempo: Up to 16 weeks
|
Up to 16 weeks
|
|
Number of subjects requiring titration of dose
Periodo de tiempo: Up to 16 weeks
|
Up to 16 weeks
|
|
Number of participants with serious adverse events as a measure of safety and tolerability
Periodo de tiempo: Up to 16 weeks
|
Up to 16 weeks
|
|
Mean of the hemoglobin (Hb) levels in the target range (10.0 to 11.0 g/dL)
Periodo de tiempo: From week 14 to 17
|
From week 14 to 17
|
|
Mean of the hemoglobin levels in the target range (9.5 to 11.5 g/dL)
Periodo de tiempo: From week 14 to 17
|
From week 14 to 17
|
|
Change from baseline in Hb during active treatment
Periodo de tiempo: Baseline and weeks 14 to 17
|
Baseline and weeks 14 to 17
|
|
Number of patients with hemoglobin levels outside the target range
Periodo de tiempo: From week 14 to 17
|
From week 14 to 17
|
|
Dose level in the evaluation period
Periodo de tiempo: Up to 16 weeks
|
Up to 16 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
28 de octubre de 2013
Finalización primaria (Actual)
23 de octubre de 2015
Finalización del estudio (Actual)
15 de diciembre de 2015
Fechas de registro del estudio
Enviado por primera vez
18 de octubre de 2013
Primero enviado que cumplió con los criterios de control de calidad
29 de octubre de 2013
Publicado por primera vez (Estimar)
5 de noviembre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de septiembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
17 de septiembre de 2019
Última verificación
1 de septiembre de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 16208
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .