A Phase 3, Long-Term Safety Study of Intravenous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin (AiME - 03)
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|ClinicalTrials.gov Identifier: NCT01628107|
Recruitment Status : Completed
First Posted : June 26, 2012
Last Update Posted : January 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Renal Failure Requiring Hemodialysis||Biological: Epoetin Hospira||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||414 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Open-Label, Multicenter, Long-Term Safety Study of Intravenous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Experimental: Epoetin Hospira
Epoetin Hospira will be administered by IV bolus injection 1 to 3 times per week per each patient's dosing schedule.
Biological: Epoetin Hospira
Rescue therapy including other ESAs (except for long-acting) may be used.
- Treatment-emergent adverse events [ Time Frame: 48 weeks ]The percentage of patients with TEAEs every day up through 7 days from the date of the first dose, each 12-week period, and the last day of the Treatment Period.
- Epoetin dosage per body weight [ Time Frame: 48 weeks ]Mean weekly epoetin dosage per kg post-dialysis dry body weight over 48 weeks and for each 12-week period.
- Mean hemoglobin levels [ Time Frame: 48 weeks ]Mean Hgb levels over 48 weeks and for each 12-week period.
- Mean hematocrit levels [ Time Frame: 48 weeks ]Mean hematocrit (Hct) levels over 48 weeks and for each 12-week period.
- Proportion of patients with Hgb measurement outside target range [ Time Frame: 48 weeks ]Proportion of patients with any Hgb measurement outside the target range during the Treatment Period.
- Percentage of patients receiving blood transfusions [ Time Frame: 48 weeks ]Percentage of patients receiving blood transfusions during the Treatment Period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628107
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