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Epogen

Phase 3

Chronic Kidney Disease | Monoclonal antibody | Nephrology |Pfizer, Inc.|Last Updated: Sep 10, 2018

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment612
FDA Designations
No designations recorded
Clinical trial landscape

Epogen · 2 trials · 2 indications

Phase 3 1Phase 1 1
NCT01473407A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With EpoetinChronic Kidney Disease
COMPLETED612 Analytics
PHASE3COMPLETED
A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
Chronic Kidney Disease
NCT01473407612
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Study Endpoints
Primary Endpoints
Mean Weekly Hemoglobin Level From Week 21 to Week 24
Week 21 up to Week 24
Mean Weekly Dosage of Study Medication From Week 21 to Week 24
Week 21 up to Week 24
Baseline-adjusted area under the serum epoetin concentration curve from the time of dose administration to 48 hours (AUC0-48)
On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)
Maximum serum epoetin concentration (Cmax)
On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)
AUC from time of dose administration to the time of the last measurable concentration (AUC0-t)
On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)

If AUC0-48 cannot be calculated then AUC from time of dose administration to the time of the last measurable concentration (AUC0-t) will be used as the primary measure.

Secondary Endpoints
Mean Weekly Hemoglobin Level Through 24 Weeks
Week 1 up to Week 24
Mean Weekly Dosage of Study Medication Through 24 Weeks
Week 1 up to Week 24
Total Dose of Study Medication Administered
Week 1 up to Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Epoetin HospiraEXPERIMENTALEpoetin Hospira
Epogen (Amgen)ACTIVE_COMPARATOREpogen (Amgen)
Arm A: Epoetin Hospira administered IV for three dosesEXPERIMENTAL -
Arm B: Epogen administered IV for three dosesACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Epoetin HospiraBIOLOGICALVariable dose
Epogen (Amgen)BIOLOGICALVariable dose
EpogenDRUGIV dose 3 times a week
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Eligibility Criteria
Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites85

Inclusion Criteria: 1. Patient is able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities 2. Hemodialysis patients with chronic renal failure and renal anemia currently on stable Epogen (Amgen) treatment for at least 4...

Countries:United StatesPuerto Rico
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Competitive Landscape -Chronic Kidney Disease 91 trials

Top 20 of 26 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN12PHASE3Savolitinib, Sunitinib
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Novo Nordisk A/S Sponsored ADR Class BNVO4PHASE3Ziltivekimab B, Ziltivekimab C
Fresenius Medical Care AG Sponsored ADRFMS8PHASE3Dialysis
Novartis AG Sponsored ADRNVS4PHASE3zigakibart
Amgen Inc.AMGN1PHASE3Etelcalcetide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK2PHASE3Mezagitamab
ProKidney Corp. Class APROK3PHASE3Renal Autologous Cell Therapy
Humacyte, Inc.HUMA1PHASE3Acellular Tissue Engineered Vessel
DexCom, Inc.DXCM1PHASE3Sotagliflozin
GSK plc Sponsored ADRGSK1PHASE1GSK4771261
Regeneron Pharmaceuticals, Inc.REGN2PHASE1Vonsetamig
Merck & Co., Inc.MRK1PHASE1MK-2828
United Therapeutics CorporationUTHR2PHASE110 GE Xenokidney
Pfizer Inc.PFE1PHASE1PF-07328948
Atea Pharmaceuticals, Inc.AVIR1PHASE1Bemnifosbuvir /Ruzasvir as a fixed-dose combination
OPKO Health, Inc.OPK1PHASE2CTAP101
Medtronic PlcMDT2 - Undisclosed
Incyte CorporationINCY1PHASE1INCB123667
Merit Medical Systems, Inc.MMSI1 - Undisclosed
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