A Safety and Efficacy Study for Epoetin Alfa in Pre-dialysis Subjects.

NCT00364260 | Completed Phase 3

• 1 other identifier: CR002056
• Study Type: interventional
• Target: 172
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if using Eprex, to maintain hemoglobin within the normal range, will prevent or delay the progression of left ventricular mass growth.

Conditions

Anemia; Kidney Failure; Left Ventricular Hypertrophy

Keywords

Anemia; epoetin alfa

Outcome Measures

Primary Outcomes (1)

• The change in left ventricular mass index from baseline to 24 months as measured by 2-dimensional targeted M-mode echocardiography.

Secondary Outcomes (1)

• The difference in renal function (calculated creatinine clearance) between groups at 24 months; The functional cardiac status (NYHA/CCS classification) between groups at 24 months;The change in SF-36 scores between groups from baseline to 24 months

Interventions

epoetin alfa DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients have had a decrease in hemoglobin \>= 10 g/L within the past 12 months and a current hemoglobin level between 110-135 g/L (men) and 100-135 g/L (women) OR a hemoglobin level between 115-125 g/L (men) and 110-120 g/L (women)
• Have a calculated creatinine clearance \<80 mL/min and \>15 mL/min

You may not qualify if:

• No uncontrolled hypertension (diastolic blood pressure\>= 105 mm Hg on average for the previous month)
• No unstable angina or cardiac procedure within the past 12 months or a planned procedure
• No myocardial infarction with the past 12 months

Sponsors & Collaborators

• Janssen-Ortho Inc., Canada: lead

Related Publications (1)

• Levin A, Djurdjev O, Thompson C, Barrett B, Ethier J, Carlisle E, Barre P, Magner P, Muirhead N, Tobe S, Tam P, Wadgymar JA, Kappel J, Holland D, Pichette V, Shoker A, Soltys G, Verrelli M, Singer J. Canadian randomized trial of hemoglobin maintenance to prevent or delay left ventricular mass growth in patients with CKD. Am J Kidney Dis. 2005 Nov;46(5):799-811. doi: 10.1053/j.ajkd.2005.08.007.

  PMID: 16253719 RESULT

MeSH Terms

Conditions

Anemia; Renal Insufficiency; Hypertrophy, Left Ventricular

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; 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

• Janssen-Ortho Inc. Clinical Trial

  Janssen-Ortho Inc., Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Study Start: December 1, 1997
• Study Completion: August 1, 2003
• Last Updated: February 1, 2011

Record last verified: 2011-01