Prevention of End Stage Kidney Disease by Darbepoetin Alfa In CKD Patients With Non-diabetic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 476
- 试验地点
- 1
- 主要终点
- Composite renal outcome of chronic dialysis, kidney transplantation, eGFR 6 mL/min/1.73m2 or less, or eGFR less than 50% of initial value.
研究概览
简要总结
The purpose of this study is to ask whether treating non-diabetic chronic kidney disease (CKD) patients with GFR 8-20mL/min/1.73m2 by darbepoetin Alfa targeting Hb between 11.0 and 13.0g/dL preserves renal function better than targeting Hb between 9.0 and11.0g/dL. The investigators also ask whether the higher Hb targeting 11 to 13g/dL will not cause higher adverse events regarding cardiovascular diseases compared with lower Hb targeting 9 to 11g/dL.
详细描述
Anemia is common among patients with chronic kidney disease (CKD) and is associated with an increased risk of cardiovascular and renal events. Although erythropoiesis stimulating agent (ESA) has been used to correct anemia, use of ESA (hemoglobin level at approximately 13 g/dL) did not reduce cardiovascular or renal events in diabetic CKD patients. Subgroup analysis of a recent randomized study suggested that use of darbepoetin alfa targeting Hb between 11 and 13 g/dL may preserve renal function better than targeting Hb between 9 and 11g/dL in non-diabetic CKD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD patients who have not received chronic dialysis
- •eGFR 8 and more and less than 20 mL/min/1.73m2 determined twice in last 12 weeks.
- •CKD patients with renal anemia at Hb less than 10g/dL within last 8 weeks
- •CKD patients with TSAT 20% and higher or serum ferritin 100ng/mL and higher.
- •CKD patients treated with standard care
- •CKD patients provided written informed consent.
排除标准
- •Diabetes (treated, or HbA1c 6.4% IFCC)
- •CKD patients treated with ESA other than epoetins and darbepoetin.
- •CKD patients treated with epoetin 24000 IU/4w or more.
- •CKD patients treated with darbepoetin 90μg/4w or more.
- •Uncontrolled hypertension (180/10mmHg and higher)
- •Heart failure (NYHA III and IV)
- •malignancy, hematological disorder
- •malnutrition
- •Active and continuous gastrointestinal tract bleeding
- •ANCA associated glomerulonephritis, acute infection, active SLE
- •CKD patients who will undergo dialysis or receive transplantation within 6 months
- •Myocardial infarction within last 6 months
- •Stroke or pulmonary embolism within last 12 months
- •Severe allergy
- •Pregnant women, women on lactation, or CKD patients who plant to get pregnant
- •Allergy against erythropoetin
- •Ineligible patients according to the investigator's judgment
研究组 & 干预措施
High Hb group
Darbepoetin alfa is given to the patients. Target Hb level is 12.0g/dL and it should be maintained greater than or equal to 11.0g/dL and less than 13.0g/dL. If the patients do not have medical history of myocardial infarction, stroke, pulmonary embolism, unstable angina, or peripheral artery disease, the target Hb level will be greater than or equal to 12.0g/dL and less than 13.0g/dL. Maximum dose of darbepoetin alfa is 240 microgram per 4 weeks.
干预措施: Darbepoetin alfa (Drug)
Low Hb group
Darbepoetin alfa is given to the patients. Target Hb level is 10.0g/dL and it should be maintained greater than or equal to 9.0g/dL and less than 11.0g/dL. If the Hb level exceeds 10.0g/dL in patients, reduce the dose amount or stop giving dose.
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Composite renal outcome of chronic dialysis, kidney transplantation, eGFR 6 mL/min/1.73m2 or less, or eGFR less than 50% of initial value.
时间窗: 96 weeks
次要结局
- Composite cardiovascular outcome of cardiovascular death, stroke, myocardial infarction, leg amputation, admission by heart failure or angina.(96 weeks)
- Time from enrollment to death by any cause(96 weeks)
- Change of eGFR from enrollment(96 weeks)
- Change of proteinuria/Cr ratio(96 weeks)
- Renal protection in patients who maintained the target Hb more than half the time(96 weeks)
- 50% renal survival(96 weeks)
- Stroke(96 weeks)
- Myocardial infarction(96 weeks)
- Development of malignancy(96 weeks)
- Number of Participants with Adverse Events baseline(96 weeks)
- Time from enrollment to initiation of dialysis(96 weeks)
- Time from enrollment to 50% reduction of eGFR from initial value(96 weeks)