At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Pieda Study: A Phase 3b Investigation Of Erythropoietin Drugs Using A Specified Dosing Algorithm: A Randomized Open Label Dosing Study In Adult Chronic Kidney Disease Subjects On Hemodialysis
In Brief
A Phase 3 clinical trial evaluating Epoetin Hospira Arm, Standard of Care Arm, and 1 other intervention for Chronic Kidney Disease (CKD). Completed, enrolled 432 participants across 45 sites in 2 countries.
Detailed Summary
A phase 3b study for subjects receiving Epogen to compare a dosing algorithm between Hospira Epoetin and Standard of Care Epogen.
Study Details
Timeline
Interventions
Epoetin Hospira Arm: Epoetin Hospira will be administered intravenously (IV) per the analogous version of the Fresenius Medical Care North America (FMCNA) cMAB 1 (inclusive of version 1.0, 1.1,...)erythropoietin stimulating agents (ESA) dosing algorithm for Epoetin Hospira for 24 weeks. Subjects will have Epoetin Hospira initiated using the same ESA dose level and frequency of administration for Epogen prior to randomization into the trial. Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.
Standard of care arm: No interventions will be performed in this arm for the clinical study; and subjects will receive ongoing standard of care, which includes Epogen administered IV per the FMCNA cMAB 5 (inclusive of versions 5.0, 5.1,....) ESA dosing algorithm and IV iron per the FMCNA protocol that is standard of care, at FMCNA clinics during the contemporaneous 24 week period.
Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.