A Study of Epoetin Beta (NeoRecormon) in Anemic Participants With Diabetes and Chronic Renal Failure Who Are Not on Dialysis
- Registration Number
- NCT02827266
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will evaluate the effect of epoetin beta (NeoRecormon) on correction of anemia and quality of life in participants with diabetes and chronic renal failure and who are not receiving dialysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
Inclusion Criteria
- Type 1 or 2 diabetes
- Chronic renal failure (stage 2 to stage 5) defined by Glomerular Filtration Rate (GFR) less than (<) 90 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2)
- Anemia related to chronic kidney disease and requiring treatment with erythropoiesis-stimulating agent (ESA) (2 values of hemoglobin less than or equal to 11 gram per deciliter [g/dL] during the 3 months prior to inclusion), and hemoglobin greater than 8 g/dL
Exclusion Criteria
- Anemia due to a non-renal cause
- Poorly controlled hypertension
- Treatment with an erythropoiesis stimulating agent (ESA) within 3 months prior to the study
- Planned dialysis in next 3 months or organ transplant
- History of cancer except for basal cell cancer and cervical cancer in situ
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Epoetin beta Epoetin beta Participants will receive epoetin beta over an 8-week correction phase and a 4-week extension or continuation phase, for a total exposure of up to 12 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Hemoglobin Greater Than (>) 11 Grams per Deciliter (g/dL) After 8-Week Correction Phase Week 8
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Hemoglobin >11 g/dL After 4-Week Extension Phase Week 12 Percentage of Participants With Hemoglobin >11 g/dL After 4-Week Continuation Phase Week 12 Number of Participants With Local Injection Site Reactions Up to 12 weeks Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to 12 weeks Number of Participants With Chronic Kidney Disease Baseline Quality of Life of Participants as Assessed From Short Form 36 (SF-36) Scores Baseline, Week 8, 12 Percentage of Participants With Positive Response to Questionnaire for Practicality and Safety of Self-administration of Study Drug Week 8, 12 Response to Treatment at the end of the Correction Phase Among Participants With Different Time Since Diabetes Diagnosis Week 8 Response to Treatment at the end of the Correction Phase Among Participants With Different Hemoglobin Levels at Baseline Week 8 Response to Treatment at the end of the Correction Phase Among Participants With Different Hematocrit at Baseline Week 8 Number of Participants per Category of History of Medical Disorders and Surgical Procedures Baseline Number of Participants per Type of Diabetes Week 8, 12