An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia
13 de junio de 2017 actualizado por: Hoffmann-La Roche
Efficacy of C.E.R.A. for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients on Dialysis , Treated According to Routine Clinical Practice
This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis receiving Mircera for the treatment of chronic renal anemia.
Eligible patients will be followed for 24 weeks.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
127
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
-
-
-
Ahmedabad, India, 380005
- Ahmedabad Dialysis Centre
-
Guwahati, India, 781007
- Excel Center
-
Kolkata, India, 600054
- ESIS Hospital; Department of Nephrology
-
Mumbai, India, 400083
- Vertex Hospital
-
New Delhi, India, 110076
- Apollo Indraprastha Hospitals; Nephrology
-
Pune, India, 411033
- Aditya Birla Memorial Hospital
-
-
Delhi
-
New Delhi, Delhi, India, 110060
- Sir Gangaram Hospital
-
-
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 a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
Patients with chronic kidney disease on dialysis receiving treatment with Mircera for chronic renal anemia
Descripción
Inclusion Criteria:
- Adult patients, 18 to 65 years of age, inclusive
- Patients with chronic kidney disease on dialysis
- ESA naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
- Adequate irons status as judged by the treating physician
Exclusion Criteria:
- Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- Clinically significant concomitant disease or disorder as defined by protocol
- Clinical suspicion of pure red cell aplasia (PRCA)
- Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
- Transfusion of red blood cells in the previous 2 months
- Pregnant women
- Contraindications for Mircera according to local prescribing information or as judged by the investigator
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
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Grupo
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean Age of Participants Treated With C.E.R.A
Periodo de tiempo: Baseline (Week 0)
|
Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25
|
Baseline (Week 0)
|
|
Mean Weight of Participants Treated With C.E.R.A
Periodo de tiempo: Baseline (Week 0)
|
Weight of the participants was measured at the Baseline and summarized with descriptive statistics.
|
Baseline (Week 0)
|
|
Number of Participants With Co-morbidity Treated With C.E.R.A
Periodo de tiempo: Up to Week 24
|
Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases.
Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.
|
Up to Week 24
|
|
Mean Time Required to Achieve Target Hemoglobin Range
Periodo de tiempo: Up to Week 24
|
The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL).
Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1
|
Up to Week 24
|
|
Percentage of Participants Achieved Target Range of Hemoglobin
Periodo de tiempo: Up to Week 24
|
The target range of Hb was 10-12 gram/deciliter (g/dL).
Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1.
The percentage of participants with Hb < 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.
|
Up to Week 24
|
|
Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.
Periodo de tiempo: Up to Week 24
|
Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.
|
Up to Week 24
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study
Periodo de tiempo: Up to Week 24
|
For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.
|
Up to Week 24
|
|
Mean Time Spent by Participants in the Hb Target Range
Periodo de tiempo: Up to Week 24
|
Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range.
The target Hb range in the study was 10-12 g/dL.
|
Up to Week 24
|
|
Evaluation of Route of Administration for C.E.R.A
Periodo de tiempo: Up to Week 24
|
C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration.
The frequency (number of injections) for both of these routes of administration used in the study was reported.
|
Up to Week 24
|
|
Evaluation of Dose Per Injection of C.E.R.A
Periodo de tiempo: Up to Week 24
|
The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information.
Mean dose per injection of C.E.R.A received by participants was reported.
|
Up to Week 24
|
|
Number of Participants Received Concomitant Medications
Periodo de tiempo: Up to Week 24
|
Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications.
The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine.
Participants treated with the each of these concomitant medications were reported.
|
Up to Week 24
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
30 de abril de 2011
Finalización primaria (Actual)
30 de septiembre de 2013
Finalización del estudio (Actual)
30 de septiembre de 2013
Fechas de registro del estudio
Enviado por primera vez
30 de agosto de 2012
Primero enviado que cumplió con los criterios de control de calidad
30 de agosto de 2012
Publicado por primera vez (Estimar)
3 de septiembre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de julio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
13 de junio de 2017
Última verificación
1 de mayo de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ML25475
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. .