NCT00146224CompletedPhase 3
A Randomized, Double-Blind, Equivalence Study of the Efficacy of Epoetin Alfa Manufactured by Deep Tank Bioreactor Technology and Epoetin Alfa Manufactured by Roller-Bottle Technology for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) Receiving Hemodialysis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 420
- Primary Endpoint
- Ratio of weekly dose at the evaluation period to the weekly dose at baseline
Study Overview
Brief Summary
The purpose of this study is to evaluate whether the efficacy of Epoetin alfa DT is equivalent to that of Epoetin alfa RB for the treatment of anemia in patients with CKD receiving hemodialysis
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of CKD and receiving hemodialysis for greater than or equal to 3 months before randomization - Mean HB level between 10 and 13 g/dL (inclusive) (mean of 2 values drawn at least 3 days apart during the screening period) - Currently receiving a stable dose of Epoetin alfa RB (i.e., EPOGEN® or PROCRIT®) for at least 6 weeks prior to randomization. Stable is defined as: less than or equal to 25% change in dose over 6 weeks, same frequency and route of administration with no more than 1 missed or withheld dose during each of the two three-week periods before randomization
Exclusion Criteria
- •Uncontrolled hypertension, defined as a pre-dialysis systolic BP greater than 180 and/or diastolic BP of greater than 110 during the screening period - Known history of severe hyperparathyroidism (PTH Greater than 1500 pg/ml within 3 months prior to enrollment) - Currently receiving immunosuppressive therapy
Arms & Interventions
Epoetin alfa RB
Active Comparator
Intervention: Epoetin alfa RB (Drug)
Epoetin alfa DT
Experimental
Intervention: Epoetin alfa DT (Drug)
Outcomes
Primary Outcomes
Ratio of weekly dose at the evaluation period to the weekly dose at baseline
Time Frame: Entire Study
Change in Heloglobin level between the screening period and the evaluation period
Time Frame: Entire Study
Secondary Outcomes
- Change from baseline Hb at each measurement timepoint(Entire Study)
- Maintaining Hemoglobin within range at each measurement timepoint(Entire Study)
- Average Epoetin alfa dose over evaluation period(evaluation period (weeks 21 - 28))
- Change from baseline dose at each measurement timepoint(entire study)
- Epoetin alfa seroreactivity(entire study)
- Subject incidence, nature and severity of adverse events(entire study)
- Hemoglobin variability(entire study)
- changes from baseline laboraotry and vital sign parameters(entire study)
Investigators
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