NCT02827266已完成3 期
NADIR: Multicentre, Open-Label Trial Evaluating a Simple NeoRecormon Regimen in Anemic Patients With Diabetes and Chronic Kidney Disease (Stage 2 to 5) Who Are Not on Dialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 主要终点
- Percentage of Participants With Hemoglobin Greater Than (>) 11 Grams per Deciliter (g/dL) After 8-Week Correction Phase
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Epoetin beta
Experimental
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.
干预措施: Epoetin beta (Drug)
结局指标
主要结局
Percentage of Participants With Hemoglobin Greater Than (>) 11 Grams per Deciliter (g/dL) After 8-Week Correction Phase
时间窗: Week 8
次要结局
- Percentage of Participants With Positive Response to Questionnaire for Practicality and Safety of Self-administration of Study Drug(Week 8, 12)
- 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)
- 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)
研究者
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