A Randomized Controlled, Single-blind, Proof-of-concept-study to Investigate the Protective Effects of Early Treatment With C.E.R.A. in Patients With Chronic Kidney Disease on Renal Disease Progression (PRIMAVERA-Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 33
- 主要终点
- Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Modification of Diet in Renal Disease With 4 Variables (MDRD-4)
研究概览
简要总结
This randomized, single-blind, proof-of-concept study will investigate the protective effects of early treatment with Mircera in participants with chronic kidney disease on renal disease progression. Participants will be randomly assigned to receive 30 microgram (mcg) Mircera as subcutaneous injection once monthly or matching placebo. Depending on change of hemoglobin values, the dose of Mircera can be adjusted to 50 mcg or 75 mcg once monthly. The anticipated time on study treatment is 24 months.
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
- Single (Participant)
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
- •For diabetic participants: Type 2 diabetes mellitus with glycated hemoglobin (HbA1c) greater than (>) 7% or anti-diabetic treatment
- •For renal allograft recipients: Status at least 6 months post transplantation
- •Chronic kidney disease stage III
- •Urinary albumin-to-creatinine ratio less than (<) 3000 milligram (mg)/gram (g) or total protein <3000 mg/ 24 hour urine sample where applicable
排除标准
- •Hemoglobin-level < 11 or > 14 g/deciliter (dL)
- •Average systolic blood pressure (SBP) > 140 millimeter of mercury (mm Hg) or average diastolic blood pressure (DBP) > 90 mm Hg
- •Initiation of angiotensin converting enzyme inhibitor, angiotensin 2 receptor blocker or aliskiren treatment less than 3 months before enrolment
- •Present and known iron deficiency
- •HbA1c >9%
研究组 & 干预措施
Mircera
干预措施: Methoxy polyethylene glycol-epoetin beta (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Modification of Diet in Renal Disease With 4 Variables (MDRD-4)
时间窗: 24 months
The yearly reduction in eGFR was calculated using the MDRD-4 formula. This formula is based on age, sex, and serum creatinine and eGFR values are calculated as follows: GFR in milliliter per minute (mL/min) per 1.73 meter square (m\^2) = 175 x Serum Cr\^-1.154 x age\^-0.203 x 0.742 (if female). The yearly reduction rate (mL/min/1.73m\^2 / Year) is defined as -365.25 multiplied by Beta, where Beta is the slope parameter derived for each participants separately by simple linear regression of the change from baseline in participant's eGFR measurements (from Baseline to Visit 24) on the actual day of measurement.
次要结局
- Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Month 24(Baseline, Month 24)
- Change From Baseline in Serum Cystatin C Concentration at Month 24(Baseline, Month 24)
- Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)(24 months)
- Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Month 24(Baseline, Month 24)
- Change From Baseline in Serum Creatinine Concentration at Month 24(Baseline, Month 24)
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(24 months)