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Clinical Trial Details

Trial ID: L0009
Source ID: NCT00440466
Associated Drug: Epoetin Alfa
Title: PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00440466/results
Conditions: Anemia|Renal Diseases
Interventions: DRUG: epoetin alfa|DRUG: epoetin alfa|DRUG: epoetin alfa
Outcome Measures: Primary: 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: Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL), Weeks 13-37 | Other: 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|Participants Who Met or Exceeded 1.5 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise, 36 weeks of treatment|Participants Who Met or Exceeded 2.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise, 36 weeks of treatment|Maximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks), 36 weeks of treatment|Number of Participants Who Died, 36 weeks of treatment
Sponsor/Collaborators: Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 430
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-07
Completion Date: 2009-03
Results First Posted: 2011-04-14
Last Update Posted: 2014-04-21
Locations: Chula Vista, California, United States|Fountain Valley, California, United States|Los Angeles, California, United States|Lynwood, California, United States|Orange, California, United States|Riverside, California, United States|San Dimas, California, United States|West Hills, California, United States|Yuba City, California, United States|Lakewood, Colorado, United States|Thornton, Colorado, United States|Washington, District of Columbia, United States|Clearwater, Florida, United States|Miami, Florida, United States|Pembroke Pines, Florida, United States|Plantation, Florida, United States|Springhill, Florida, United States|Tampa, Florida, United States|West Palm Beach, Florida, United States|Zephyrhills, Florida, United States|Atlanta, Georgia, United States|Augusta, Georgia, United States|Macon, Georgia, United States|Chicago, Illinois, United States|Evergreen Park, Illinois, United States|Peoria, Illinois, United States|Shreveport, Louisiana, United States|Baltimore, Maryland, United States|Boston, Massachusetts, United States|Methuen, Massachusetts, United States|Plymouth, Massachusetts, United States|Springfield, Massachusetts, United States|Detroit, Michigan, United States|Flint, Michigan, United States|Picayune, Mississippi, United States|St. Louis, Missouri, United States|Great Neck, New York, United States|New York, New York, United States|Springfield Gardens, New York, United States|Charlotte, North Carolina, United States|Greenville, North Carolina, United States|Monroe, North Carolina, United States|Dayton, Ohio, United States|Maumee, Ohio, United States|Allentown, Pennsylvania, United States|Doylestown, Pennsylvania, United States|Erie, Pennsylvania, United States|Lancaster, Pennsylvania, United States|Philadelphia, Pennsylvania, United States|Wynnewood, Pennsylvania, United States|Providence, Rhode Island, United States|Bamberg, South Carolina, United States|Columbia, South Carolina, United States|Orangeburg, South Carolina, United States|Rock Hill, South Carolina, United States|Sumter, South Carolina, United States|Arlington, Texas, United States|Fountain Valley, Texas, United States|Houston, Texas, United States|Longview, Texas, United States|San Antonio, Texas, United States|Fairfax, Virginia, United States|Hampton, Virginia, United States|Petersburg, Virginia, United States|Richmond, Virginia, United States|Tacoma, Washington, United States
URL: https://clinicaltrials.gov/show/NCT00440466

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress