CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 406 enrolled
Drug / intervention
Epoetin Hospirabiological
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Patient completed the core study Treatment Period up to Week 24 and is willing to continue open-label Epoetin Hospira for up to 48 weeks
  • ✓Able to provide written informed consent
  • ✓If female, must be postmenopausal for at least 1 year, surgically sterile, or using effective birth control
Key exclusion· 9
  • ✕Serious or severe adverse event in core study probably or definitely related to epoetin that precluded safe use
  • ✕Myocardial infarction, stroke, severe angina, coronary/peripheral bypass, decompensated heart failure, pulmonary embolism, or deep vein thrombosis during core study
  • ✕Active, uncontrolled systemic, inflammatory, or malignant disease that developed during core study, including demyelinating diseases, infections, or mental disease
  • ✕Known hypersensitivity or idiosyncratic reaction to epoetin or its excipients (including albumin)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01628107
NCT01628107Phase 3Completed
CompareCT.gov

A Phase III, Open-label, Multicenter, Long-term Safety Study Of Intravenous Epoetin Hospira In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment

Pfizer·interventional·Posted Jun 26, 2012·Updated Jul 19, 2018

In Brief

A Phase 3 clinical trial evaluating Epoetin Hospira for Chronic Renal Failure Requiring Hemodialysis. Completed, enrolled 406 participants across 110 sites in 2 countries.

Detailed Summary

The purpose of the study is to determine the long-term safety in treatment-emergent adverse events (TEAEs) of intravenous (IV) administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal failure and on hemodialysis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Renal Failure Requiring Hemodialysis
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 26, 2012
Enrollment StartJul 16, 2012
Primary CompletionJan 2, 2015
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.0 years ago

Interventions

Epoetin Hospirabiological

Intravenous (IV) injection