Clinical trial NCT00146224: Efficacy of Epoetin Alfa Deep Tank in Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nephrology
Keywords: anemia
chronic kidney disease, CKD
hemodialysis
epoetin
Epogen®
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Ratio of weekly dose at the evaluation period to the weekly dose at baseline
timeFrame: Entire Study
measure: Change in Heloglobin level between the screening period and the evaluation period
timeFrame: Entire Study
Secondary outcomes:
measure: Change from baseline Hb at each measurement timepoint
timeFrame: Entire Study
measure: Maintaining Hemoglobin within range at each measurement timepoint
timeFrame: Entire Study
measure: Average Epoetin alfa dose over evaluation period
timeFrame: evaluation period (weeks 21 - 28)
measure: Change from baseline dose at each measurement timepoint
timeFrame: entire study
measure: Epoetin alfa seroreactivity
timeFrame: entire study
measure: Subject incidence, nature and severity of adverse events
timeFrame: entire study
measure: Hemoglobin variability
timeFrame: entire study
measure: changes from baseline laboraotry and vital sign parameters
timeFrame: entire study
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Lei L, Olson K. Evaluating statistical methods to establish clinical similarity of two biologics. J Biopharm Stat. 2010 Jan;20(1):62-74. doi: 10.1080/10543400903115082.