Efficacy of Epoetin Alfa Deep Tank in Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis

Nephrology Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146224
• Other study ID #: 20050113
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: February 25, 2010
• Start date: September 2005
• Est. completion date: January 2007

Study information

• Verified date: February 2010
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Nephrology
• Renal Insufficiency, Chronic

Intervention

Drug:
• Epoetin alfa RB
Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.
• Epoetin alfa DT
Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of weekly dose at the evaluation period to the weekly dose at baseline		Entire Study	No
Primary	Change in Heloglobin level between the screening period and the evaluation period		Entire Study	No
Secondary	Change from baseline Hb at each measurement timepoint		Entire Study	No
Secondary	Maintaining Hemoglobin within range at each measurement timepoint		Entire Study	No
Secondary	Average Epoetin alfa dose over evaluation period		evaluation period (weeks 21 - 28)	No
Secondary	Change from baseline dose at each measurement timepoint		entire study	No
Secondary	Epoetin alfa seroreactivity		entire study	Yes
Secondary	Subject incidence, nature and severity of adverse events		entire study	Yes
Secondary	Hemoglobin variability		entire study	Yes
Secondary	changes from baseline laboraotry and vital sign parameters		entire study	Yes

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling