RETACRIT Clinical Data

RETACRIT subcutaneous (SC) and intravenous (IV) clinical trials2
  • US-based clinical trial population (N=932)
Designed to demonstrate biosimilarity in efficacy and safety in patients with chronic kidney disease (CKD)
Study participants previously taking Epogen were randomized to either remain on Epogen or were switched to RETACRIT*
Study Descriptions
The biosimilar clinical development program for RETACRIT included 2 randomized, multicenter, double-blind, active-controlled trials in adult subjects with CKD on hemodialysis.
  • Study EPOE-10-13 was a comparative efficacy and safety study (n=320, randomized) in which RETACRIT or the Epogen reference product was administered subcutaneously for up to 16 weeks.
  • Study EPOE-10-01 was a comparative efficacy and safety study (n=612) in which RETACRIT or the Epogen reference product was administered intravenously for up to 24 weeks.2
Primary Endpoints2
The co-primary efficacy endpoints for both comparative clinical studies were:
  • Difference between RETACRIT and Epogen in mean weekly hemoglobin (Hb) levels during the last 4 weeks of the double-blind treatment period
  • Difference between RETACRIT and Epogen in mean weekly dosage per kg body weight during the last 4 weeks of the double-blind treatment period
Secondary analyses of 7 endpoints conducted on the ITT population provided supportive results for the conclusion of no statistically significant difference between RETACRIT and Epogen.
  • Mean weekly Hb level§
  • Mean weekly epoetin dose per kg body weight§
  • Mean weekly Hb level over each 4-week interval||
  • Mean weekly epoetin dose per kg body weight over each 4-week interval||
  • Total epoetin dose§
  • Proportion of subjects within and outside the target range for mean weekly Hb of 9.0 to 11.0 g/dL§
  • Proportion of subjects who received blood transfusions§
*RETACRIT does not have a designation of interchangeability with Epogen/Procrit.
Calculated from Hb levels and dose data collected during the last 4 weeks of treatment in the double-blind Maintenance Period with each study drug.
For SC (16-week Treatment Period) and IV (24-week Treatment Period) clinical studies.
§No statistically significant difference was observed between treatment groups.
||Results were comparable; no test for statistical significance was performed.
Study Designs
RETACRIT showed no clinically significant differences in efficacy versus Epogen2
No clinically significant differences were noted between RETACRIT and Epogen in mean weekly Hb levels achieved in CKD patients during the last 4 weeks of treatment.2
Statistical analysis supporting biosimilarity: 95% confidence interval for LS mean for the difference between RETACRIT and Epogen treatment groups during last 4 weeks of maintenance was -0.17 to 0.24 g/dL/week (SC study) and -0.25 to 0.01 g/dL/week (IV study) and was contained within prespecified acceptance limits of +/-0.5 g/dL/week.
RETACRIT demonstrated no clinically meaningful difference in mean weekly dose compared to Epogen2
The mean weekly dose needed to maintain Hb target levels in CKD patients during the last 4 weeks of treatment had no clinically meaningful difference between treatment groups in either study.2
*Statistical analysis supporting biosimilarity: 95% confidence interval for LS mean for the difference between RETACRIT and Epogen treatment groups during last 4 weeks of maintenance was -14.51 to 9.82 U/kg/week (SC study) and -10.40 to 11.13 U/kg/week (IV study) and was contained within prespecified acceptance limits of +/-45 U/kg/week.
RETACRIT displayed similar transfusion rates to Epogen2
In 2 comparative studies, the incidence of transfusion was not statistically different between treatment groups in either study.2
*Prespecified secondary efficacy endpoint. Other secondary efficacy analyses conducted on the ITT population (7 endpoints) provided supportive results for the conclusion of no statistically significant differences between treatment groups.