An Open, Randomized, Multi-centre Trial to Investigate the Effect of Anemia Correction on Cardiac Structure and Function in Patients With Early Diabetic Nephropathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 170
- 主要终点
- Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15
研究概览
简要总结
This study will assess the effect of anemia correction with NeoRecormon on cardiac structure and function in patients with early diabetic nephropathy. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients >=18 years of age;
- •type 1 or type 2 diabetes;
- •stable glycemic control for >=3 months;
- •diabetic nephropathy.
排除标准
- •women who are pregnant, breastfeeding, or unwilling to use a reliable contraceptive method;
- •previous treatment with erythropoietin or other erythropoietic substance;
- •nondiabetic renal disease, nephrotic syndrome;
- •blood transfusion within the 3 months prior to enrollment;
- •administration of any investigational drug within 30 days preceding the study start, and during the study.
研究组 & 干预措施
Group 2 (No/Late Epoetin Beta)
Participants will receive their standard treatment for 15 months but no treatment for anemia correction unless Hb level will be less than (<) 10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level will be <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment will be as per investigator discretion.
干预措施: Epoetin beta (Drug)
Group 1 (Early Epoetin Beta)
Along with their standard treatment participants will receive epoetin beta at a starting dose of 2000 International Units (IU) subcutaneously (SC) once weekly to reach and maintain target hemoglobin (Hb) between 13 and 15 grams per deciliter (g/dL), for 15 months. Epoetin beta doses will be adjusted according to individual participant's Hb level. Standard treatment will be as per investigator discretion.
干预措施: Epoetin beta (Drug)
结局指标
主要结局
Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15
时间窗: Baseline, Month 15
LVMI (in g/m\^2) = (0.8 \[1.04 {(LVEDD + IVS + PWT)\^3 - (LVEDD)\^3}\] + 0.6) divided by BSA. Here, LVEDD = left ventricular end diastolic diameter (in centimeters \[cm\]); PWT = left ventricular posterior wall thickness in diastole (in cm); IVS = interventricular septal wall thickness in diastole (in cm). Echocardiogram was performed at baseline and Month 15 to interpret LVMI which was expressed in grams per meter square (g/m\^2).
次要结局
- Left Ventricular End Systolic Volume Index (LVESVI)(Baseline, Months 6 and 15)
- Left Ventricular End Diastolic Volume Index (LVEDVI)(Baseline, Months 6 and 15)
- Fractional Myocardial Shortening (FS)(Baseline, Months 6 and 15)
- Left Ventricular Ejection Fraction (LVEF)(Baseline, Months 6 and 15)
- Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL(Week 26 up to Week 64)