PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients

NCT00440466 | Completed Phase 3 Results DMC

• 2 other identifiers: CR010414EPOAKD3002
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 66

Brief Summary

The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with anemia associated with chronic kidney disease, is not less effective than treatment with epoetin alfa that is given once a week

Conditions

Anemia; Renal Diseases

Keywords

Anemia; Reduction in the number of erythrocytes; Hemoglobin low level; Red blood cell deficiency; Procrit; Epoetin alfa; Chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment

  from baseline (Week 1) to the last 12 weeks of treatment

Secondary Outcomes (1)

• Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)

  Weeks 13-37

Other Outcomes (7)

• Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)

  36 weeks of treatment

• Maximum Hemoglobin Concentration in Grams Per Deciliter (g/dL)

  36 weeks of treatment

• Participants Who Met or Exceeded 1.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise

  36 weeks of treatment

Study Arms (3)

001

EXPERIMENTAL

epoetin alfa Continue pre-study once weekly dose of epoetin alfa for 36 weeks

Drug: epoetin alfa

003

EXPERIMENTAL

epoetin alfa Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

Drug: epoetin alfa

002

EXPERIMENTAL

epoetin alfa Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks

Drug: epoetin alfa

Interventions

epoetin alfa DRUG

Continue pre-study once weekly dose of epoetin alfa for 36 weeks

001

Eligibility Criteria

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

You may qualify if:

• Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular filtration rate (GFR) \>=15 mL/min per 1.73 m2 and \<60 mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory
• Hemoglobin level between 10.0 and 11.9 g/dL during the 4 weeks before randomization
• History of increase in hemoglobin after the initial dose
• Stable dose of epoetin alfa given once-weekly before randomization.

You may not qualify if:

• Uncontrolled hypertension
• Iron deficiency
• iron overload
• severe congestive heart failure
• Active infection
• Recent heart attack, Stroke or blood clot.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (66)

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Chula Vista, California, United States

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Fountain Valley, California, United States

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Los Angeles, California, United States

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Lynwood, California, United States

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Orange, California, United States

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Riverside, California, United States

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San Dimas, California, United States

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West Hills, California, United States

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Yuba City, California, United States

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Lakewood, Colorado, United States

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Thornton, Colorado, United States

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Washington D.C., District of Columbia, United States

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Clearwater, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Plantation, Florida, United States

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Springhill, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Zephyrhills, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Macon, Georgia, United States

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Chicago, Illinois, United States

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Evergreen Park, Illinois, United States

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Peoria, Illinois, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Methuen, Massachusetts, United States

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Plymouth, Massachusetts, United States

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Springfield, Massachusetts, United States

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Detroit, Michigan, United States

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Flint, Michigan, United States

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Picayune, Mississippi, United States

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St Louis, Missouri, United States

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Great Neck, New York, United States

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New York, New York, United States

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Springfield Gardens, New York, United States

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Charlotte, North Carolina, United States

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Greenville, North Carolina, United States

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Monroe, North Carolina, United States

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Dayton, Ohio, United States

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Maumee, Ohio, United States

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Allentown, Pennsylvania, United States

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Doylestown, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Wynnewood, Pennsylvania, United States

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Providence, Rhode Island, United States

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Bamberg, South Carolina, United States

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Columbia, South Carolina, United States

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Orangeburg, South Carolina, United States

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Rock Hill, South Carolina, United States

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Sumter, South Carolina, United States

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Arlington, Texas, United States

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Fountain Valley, Texas, United States

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Houston, Texas, United States

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Longview, Texas, United States

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San Antonio, Texas, United States

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Fairfax, Virginia, United States

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Hampton, Virginia, United States

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Petersburg, Virginia, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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Related Links

• A Randomized, Open-label, Multicenter Study of Epoetin Alfa Comparing Two Dosing Regimens, Once-every-two-weeks and Once-every-four-weeks, with Once-weekly Dosing Regimen for Maintenance Treatment in Anemic Subjects with Chronic Kidney Disease

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

Results Point of Contact

• Title: Peter Bowers
• Organization: J&J PRD

908-927-2116

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2007
• First Posted: February 27, 2007
• Study Start: July 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 21, 2014
• Results First Posted: April 14, 2011

Record last verified: 2014-04

Locations

US (66)