Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa (ACCESS)
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|ClinicalTrials.gov Identifier: NCT01693029|
Recruitment Status : Completed
First Posted : September 26, 2012
Results First Posted : May 12, 2017
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anemia Chronic Kidney Disease (CKD)||Drug: HX575 epoetin alfa Drug: US-licensed epoetin alfa||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||435 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of HX575 Epoetin Alfa vs. US Licensed Epoetin Alfa (Epogen®/Procrit®) in the Treatment of Anemia Associated With Chronic Kidney Disease|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||March 2015|
Experimental: HX575 epoetin alfa
HX575, recombinant human epoetin alfa
Drug: HX575 epoetin alfa
Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL.
Active Comparator: US-licensed epoetin alfa
US-licensed recombinant human epoetin alfa
Drug: US-licensed epoetin alfa
Solution for subcutaneous injection.
- Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28) [ Time Frame: Week -4 to Day1 and Week 21-28 ]Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .
- Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28) [ Time Frame: Week -4 to Day1 and Week 21-28 ]Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .
- Mean Weekly Dose During Evaluation Period (Week 21-28) [ Time Frame: Week 21-28 ]Mean weekly study drug dose during evaluation period (Week 21-28)
- Incidence of Antibody Formation Against Epoetin [ Time Frame: 52 weeks ]Number of patients with positive antidrug antibody (ADA) finding at any time during their treatment period. Count includes 2 patients (1 in each arm) that already had a positive ADA Baseline finding. ADA testing performed by by Radio-Immuno-Precipitation assay. No patient developed neutralizing antibodies.
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): NCT01693029
|Study Director:||Sandoz Biopharmaceutical Clinical Development||Sandoz Biopharmaceuticals|