A Randomized, Comparative Study of HEMAX PFS® Versus EPREX/ ERYPO® in the Treatment of Anemia With Epoetin Alfa in Patients With Predialysis Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 11
- 主要终点
- Efficacy Evaluation Through Change in Hemoglobin Levels
研究概览
简要总结
Phase III, multicenter, randomized, open, controlled clinical trial. A study designed as phase III, in 120 patients with chronic renal failure in the pre-dialysis stage, evaluate efficacy and safety of Hemax PFS® (PFS: prefilled syringes) vs the innovator erythropoietin alfa product (Eprex®).
详细描述
This was a Phase IIIB, multicenter, randomized, open-label study to compare two products with epoetin alfa (HEMAX® PFS versus EPREX/ERYPO®).
This trial was open-label for both the patient and the investigator, but blinded in the performance of laboratory analyses.
The overall objective of the study was to evaluate the efficacy and the safety of HEMAX® PFS compared to EPREX/ERYPO®, following a dose-titration and maintenance scheme similar to the one used in the regular clinical practice.
All patients received HEMAX® PFS or EPREX/ERYPO® twice a week subcutaneously during 12 weeks of titration, switching then to an equivalent weekly dose during 12 additional maintenance weeks. During the dosing scheme switch from twice a week to once weekly, each patient continued receiving the treatment assigned at randomization.
The study conclude with n=43 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Patients with pre-dialysis chronic renal failure (CRF) defined by a glomerular filtration rate (calculated with the Modification of Diet in Renal Disease Study formula) ≥15 ml/ min and <60 ml/ min, by 1.73 m2
- •Anemic patients that should be treated and levels of hemoglobin <10.5 g/dl and ≥ 7.5 g/dl.
- •Patients that have the will and capacity to sign a written inform consent.
- •Post-menopause women for at least 2 years, or sterile by surgery for at least 6 months. Women of childbearing age must have a negative pregnancy test at baseline and be willing to get an adequate method of contraception.
排除标准
- •Patients that are planned to be on dialysis or have a renal transplant in the following 6 months.
- •Transferrin iron Saturation < 20%.
- •Etiology of renal failure (as secondary to autoimmune diseases) that, to the judge to the physician, can affect the normal development of the protocol.
- •Active bleeding or history of hemorrhage that have led to a significative decrease of hematocrit in the last 30 days.
- •Non-controlled hypertension (≥160 mm Hg of systolic pressure and/or ≥100 mm Hg of diastolic pressure with anti-hypertensive treatment).
- •Anemia caused by any other cause than renal disease.
- •Having a transfusion in the last 3 months before basal visit or during screening.
- •Treatment with an erythropoiesis stimulant in the last 3 months before basal visit or screening.
- •Increase risk of thromboembolic disease: history of arterial thromboembolia (stroke, transient ischemic attack, Acute coronary syndrome, etc.) in the last 6 months or venous in the last 12 months before screening; surgery in the last month before screening; prolong immobilization or orthopedic surgery programmed in the following 6 months or any other condition that to the judge of the investigator can increase the risk of thromboembolism.
- •Hematological disease or myelodysplastic syndrome or history of hematological neoplasm or solid tumor in the last 5 years.
- •History of congestive heart failure
- •Pregnancy or breast feeding
- •Refuse to participate in the protocol or any medical condition, that in the investigator opinion, is significant to prevent the participant from being included in the trial.
研究组 & 干预措施
Eprex/Erypo
Receive EPREX/ ERYPO® subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
干预措施: Erythropoietin alfa (Biological)
Hemax PFS
receive HEMAX® PFS subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
干预措施: Erythropoietin alfa (Biological)
结局指标
主要结局
Efficacy Evaluation Through Change in Hemoglobin Levels
时间窗: 12 weeks of treatment
Evaluate the efficacy of treatment with erythropoietin alfa through the measured changes in levels of hemoglobin from baseline value to the mean value of the 8 to 12 weeks of treatment, comparing patients treated with HEMAX® PFS versus EPREX/ ERYPO®.
Adverse Events and Adverse Reactions (Safety and Tolerability) at Weeks 12 and 24.
时间窗: 24 weeks of treatment
Evaluate the safety through the incidence of adverse events and adverse reactions asessed after 12 and 24 weeks of treatment (week 24 reported which includes those evaluated at week 12), comparing patients treated with HEMAX® PFS versus those treated with EPREX/ ERYPO®.
次要结局
- Percentage of Responder Patients(12 weeks of treatment)
- Percentage of Patients That Required Any Transfusion(12 weeks of treatment)
- Change of Hemoglobin Level at Week 12 of Treatment(Intragroup efficacy until week 12)
- Evaluate the Efficacy Between Arms 24 Weeks: Week Doses in the Titration(Intragroup efficacy until week 24)
- Incidence of Anti-drug Antibodies (Immunogenicity)(12 and 24 weeks of treatment)
- Concentration of Hepcidin(24 weeks of treatment)