Epoetin Alfa (EPO) in Subjects With Chronic Kidney Disease (CKD)

NCT00156962 | Terminated Phase 3

• 2 other identifiers: 20040259NOT APPLILCABLE
• Study Type: interventional
• Target: 850
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to look at subject incidence of adverse events.

Conditions

Chronic Kidney Disease

Keywords

Epogen; Procrit; Chronic Kidney Disease; Anemia Treatment

Outcome Measures

Primary Outcomes (1)

• Subject incidence of adverse events

  Entire Study

Secondary Outcomes (2)

• Epoetin alfa antibodies

  Entire Study

• Changes from baseline laboratory and vital signs

  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 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 11.0 - 13.0 g/dL

Epoetin alfa DT

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 11.0 - 13.0 g/dL

Epoetin alfa RB

Eligibility Criteria

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

You may not qualify if:

• Patients known to have tested positive at any time in the past for antibodies to erythropoietic proteins. - Systemic hematological disease (eg. sickle cell anemia, myelodysplastic syndromes, hematological malignancy); myeloma; hemolytic anemia. - Other investigational products are excluded. - Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s). - Psychiatric, addictive, or any other disorder that compromises ability to give truly informed consent for participation in this study. - Pregnant or breast feeding (women of child-bearing potential must be taking adequate contraceptive precautions). - Anticipating or scheduled for a living-related kidney transplant. - Currently receiving home hemodialysis treatment. - Currently receiving immunosuppressive therapy.

Sponsors & Collaborators

• Amgen: lead

Related Links

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

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: April 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: July 21, 2008

Record last verified: 2008-07