A Phase 3, Open-label, Multicenter, Long-term Safety Study Of Subcutaneous Epoetin Hospira In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chronic Renal Failure Requiring Hemodialysis
- Sponsor
- Pfizer
- Enrollment
- 170
- Locations
- 80
- Primary Endpoint
- Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal failure and on hemodialysis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Maintenance Period up to and including Week 16 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.
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12
Time Frame: 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
Time Frame: 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 13 to 24
Time Frame: 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 25 to 36
Time Frame: 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.
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48
Time Frame: 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 48
Time Frame: 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.
Secondary Outcomes
- Mean Hemoglobin Levels: Over Week 1 to 48(Week 1 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 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)
- Percentage of Participants With Hemoglobin Level Outside Target Range(Week 1 up to Week 48)
- Percentage of Participants Who Received Blood Transfusions(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: Over Week 1 to 48(Week 1 up to Week 48)