Treatment of Anemia in Diabetic Subjects With CKD
Palabras clave
Abstracto
Descripción
This is a prospective, randomized, double blind, placebo controlled, multi-center study in diabetic subjects with the anemia of chronic kidney disease. Subjects will be randomly assigned in a 1:1 ratio to receive either Epoetin alfa (PROCRIT®) or matching placebo for sixteen weeks. Epoetin alfa (PROCRIT®) is indicated for the treatment of anemia associated with chronic renal failure (pre-dialysis), non-myeloid malignancies receiving chemotherapy, in HIV-infected subjects receiving zidovudine therapy, and in anemic subjects undergoing elective non-cardiac, non-vascular surgery to reduce the need for allogenic blood transfusion during high-volume blood loss procedures. This study is being undertaken to assess, under well-controlled conditions, the effect of weekly Epoetin alfa (PROCRIT®) treatment on hemoglobin response in diabetic subjects with the anemia of chronic kidney disease. The study hypothesis is that weekly PROCRIT treatment will be effective in achieving a hemoglobin response than placebo, where hemoglobin response is defined by at least a 1 gram/deciliter increase from baseline by Week 17. The subjects are administered study drug (PROCRIT® or matching placebo) once weekly by subcutaneous injection by a health care professional for 16 weeks. The initial dose of study drug is either PROCRIT® 10,000 U (1.0 mL) or matching placebo. The maximum dose administered is 20,000 U (2.0 mL).
fechas
| Verificado por última vez: | 02/28/2010 |
| Primero enviado: | 10/13/2005 |
| Inscripción estimada enviada: | 10/13/2005 |
| Publicado por primera vez: | 10/17/2005 |
| Última actualización enviada: | 06/07/2011 |
| Última actualización publicada: | 06/09/2011 |
| Fecha de inicio real del estudio: | 02/28/2005 |
| Fecha estimada de finalización del estudio: | 08/31/2005 |
Condición o enfermedad
Intervención / tratamiento
Drug: Epoetin alfa
Fase
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Subjects with a clinical diagnosis of diabetes mellitus - History of documented proteinuria or microalbuminuria - A glomerular filtration rate between 15 and 90 mL/minute/1.73m2 - Subjects with hemoglobin greater than or equal to 9.0 /dL and less than or equal to 11.0 g/dL. Exclusion Criteria: - A current diagnosis of poorly controlled high blood pressure (hypertension) (systolic blood pressure > 150 mm Hg or diastolic blood pressure > 100 mm Hg) after adequate anti hypertensive therapy - Subjects with severe neuropathy or peripheral vascular disease with gait instability - Subjects scheduled to receive dialysis during the course of the study - Subjects with a transferrin saturation < 20% or ferritin level < 50 ng/dL - Subjects with active malignancy, defined as a malignancy requiring current therapy (surgery, chemotherapy, or radiotherapy) or a history of treatment for malignancy in the last 5 years. |
Salir
Medidas de resultado primarias
1. The primary endpoint is the hemoglobin response rate, defined as the proportion of subjects who achieve at least a 1 gram per deciliter hemoglobin increase from baseline by Week 17. [undefined]
Medidas de resultado secundarias
1. The secondary endpoints include evaluation of health-related quality life, hemoglobin change over time, time to hemoglobin response, and transfusion utilization. [undefined]
