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

NCT00146224 | Completed Phase 3

• 1 other identifier: 20050113
• Study Type: interventional
• Target: 420
• Locations: 0 countries
• Sites: N/A

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

Conditions

Nephrology

Keywords

anemia; chronic kidney disease, CKD; hemodialysis; epoetin; Epogen®

Outcome Measures

Primary Outcomes (2)

• Ratio of weekly dose at the evaluation period to the weekly dose at baseline

  Entire Study

• Change in Heloglobin level between the screening period and the evaluation period

  Entire Study

Secondary Outcomes (8)

• 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

Study Arms (2)

Epoetin alfa RB

ACTIVE COMPARATOR

Drug: Epoetin alfa RB

Epoetin alfa DT

EXPERIMENTAL

Drug: Epoetin alfa DT

Interventions

Epoetin alfa RB DRUG

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 RB

Epoetin alfa DT DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Amgen: lead

Related 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.

  PMID: 20077249 RESULT

Related Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• FDA-approved Drug Labeling

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 7, 2005
• Study Start: September 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: February 26, 2010

Record last verified: 2010-02