A Study to Assess Disability in Anemic Elderly Patients With Kidney Disease Receiving PROCRIT (Epoetin Alfa)

NCT00338468 | Terminated Phase 4

• 1 other identifier: CR004606
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess disability in anemic patients over the age of 65 who have kidney disease and are receiving weekly PROCRIT® (Epoetin Alfa, a glycoprotein that stimulates red blood cell production).

Conditions

Anemia; Kidney Diseases

Keywords

Anemia; Elderly; Hemoglobin level; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Change in physical function score as measured by the Six Minute Walk Test (6MWT) and Short Physical Performance (SPP) Summary Score compared from Baseline to Week 5, Week 9, Week 13, Week 17/ Early Withdrawal and Week 20/Follow-up.

Secondary Outcomes (1)

• Proportion of patients who achieve the target hemoglobin levels of > 13.0 g/dL and < =14.0 g/dL (independent of transfusion within 1 month of assessment) compared from Baseline to Week 5, Week 9, Week 13, Week 17/ Early Withdrawal and Week 20/Follow-up.

Interventions

epoetin alfa DRUG

Eligibility Criteria

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

You may qualify if:

• Patients having chronic anemia and chronic renal failure
• have lessened physical function
• be community dwelling (defined as not admitted to an assisted nursing facility, nursing home or hospital at the time of enrollment. An assisted nursing facility is considered any living situation where daily care is being provided by recognized health care professionals from that facility.)

You may not qualify if:

• History of bacterial infection requiring hospitalization and intravenous antibiotics or transfusion within 1 month prior to enrollment
• anemia due to iron, folate, or vitamin B12 deficiency
• gastrointestinal bleeding
• anticipated to begin dialysis within 4 months following enrollment into the study
• History of thrombotic disease within the past 3 months, or on anticoagulation therapy at enrollment.

Sponsors & Collaborators

• Ortho Biotech Products, L.P.: lead

Related Links

• An Open-Label Pilot Study to Assess Disability in Anemic Elderly Patients with Chronic Kidney Disease Receiving PROCRIT (Epoetin alfa)

MeSH Terms

Conditions

Anemia; Kidney Diseases; Renal Insufficiency, Chronic

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; 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

• Ortho Biotech Products, L.P. Clinical Trial

  Ortho Biotech Products, L.P.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 16, 2006
• First Posted: June 20, 2006
• Study Start: November 1, 2003
• Study Completion: September 1, 2005
• Last Updated: May 19, 2011

Record last verified: 2010-03