A Phase III, Open-label, Multicenter, Long-term Safety Study Of Intravenous Epoetin Hospira In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 406
- 试验地点
- 110
- 主要终点
- Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24
研究概览
简要总结
The purpose of the study is to determine the long-term safety in treatment-emergent adverse events (TEAEs) of intravenous (IV) administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal failure and on hemodialysis.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is able to provide written Informed Consent after the risks and benefits of the study have been explained prior to any study-related activities.
- •Patient previously completed the core study Treatment Period up to and including Week 24 study assessments per protocol and is willing to continue open-label Epoetin Hospira for up to 48 weeks.
- •If female, patient must be postmenopausal for at least 1 year prior to enrollment, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing at least 1 of the following methods of birth control:
- •Hormonal contraceptives (oral, parenteral, or transdermal) for at least 3 months prior to enrollment
- •Intrauterine device
- •Double-barrier method (condoms, contraceptive sponge, diaphragm, or vaginal ring with spermicidal jellies or cream)
- •If hormonal contraceptives are used, the specific contraceptive must have been used for at least 3 months prior to enrollment. If the patient is currently using a hormonal contraceptive, she should also use a barrier method during this study and for at least 30 days following the administration of the patient's last open-label dose.
- •Adequate methods of contraception to prevent pregnancy are to be maintained throughout the course of the study in both male and female study subjects.
排除标准
- •Patient had a serious or severe adverse event in the core study that, in the opinion of the Investigator, was probably or definitely related to epoetin use and precluded safe use of epoetin.
- •Any of the following that developed during the core study and prior to enrollment:
- •Myocardial infarction
- •Stroke (cerebrovascular accident)/cerebrovascular insult (minor stroke) or transient ischemic attack/intracerebral bleeding/cerebral infarction
- •Severe/unstable angina
- •Coronary angioplasty, bypass surgery, or peripheral artery bypass graft
- •Decompensated congestive heart failure (New York Heart Association [NYHA] class IV)
- •Pulmonary embolism
- •Deep vein thrombosis or other thromboembolic event
- •Received live or attenuated vaccination (except flu vaccination)
- •A patient with any active, uncontrolled systemic, inflammatory, or malignant disease that developed during the core study and in the Investigator's opinion may be significant to exclude participation in the study, including but not limited to demyelinating diseases such as multiple sclerosis, microbial, viral, or fungal infection or mental disease.
- •Any newly developed significant drug sensitivity or a significant allergic reaction to any drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (or its excipients, including albumin) or any other related drugs that in the judgment of the Investigator is exclusionary for study participation.
- •A female patient who is pregnant, lactating, or planning a pregnancy during the study.
- •History of drug abuse or alcohol abuse during the core study prior to enrollment as determined by the Investigator.
- •Current participation or participation in a drug or other investigational research study within 30 days prior to enrollment (except the core study or any observational studies with prior written approval from Hospira).
- •May not be able to comply with the requirements of this clinical study, communicate effectively with study personnel, or is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
- •Evidence of human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg).
- •A patient who, in the Investigator's opinion, has any clinically significant abnormal laboratory results that may impact patient safety.
研究组 & 干预措施
Epoetin Hospira
Epoetin Hospira will be administered by IV bolus injection 1 to 3 times per week per each patient's dosing schedule. Other ESAs (except for long-acting) may be used as rescue therapy.
干预措施: Epoetin Hospira (Biological)
结局指标
主要结局
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24
时间窗: Week 13 up to Week 24
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48
时间窗: Week 1 up to Week 48
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48
时间窗: Week 37 up to Week 48
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12
时间窗: Week 1 up to Week 12
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1
时间窗: Up through 7 days after first dose of study drug (Week 1)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36
时间窗: Week 25 up to Week 36
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
次要结局
- Mean Hemoglobin Levels: Over Week 1 to 48(Week 1 up to Week 48)
- Mean Hemoglobin Levels for Interval of 12 Weeks(Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48)
- Mean Hematocrit Levels for Interval of 12 Weeks(Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48)
- Mean Weekly Dosage of Epoetin Hospira : Over Week 1 to 48(Week 1 up to Week 48)
- Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks(Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48)
- Mean Hematocrit Levels: Over Week 1 to 48(Week 1 up to Week 48)
- Percentage of Participants With Hemoglobin Level Outside the Target Range(Week 1 up to Week 48)
- Percentage of Participants Who Received Blood Transfusions(Week 1 up to Week 48)