Clinical Trial Details
| Trial ID: | L1688 |
| Source ID: | NCT00440557 |
| Associated Drug: | Epoetin Alfa 3 Times Weekly /Once Weekly |
| Title: | An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00440557/results |
| Conditions: | Anemia |
| Interventions: | DRUG: Epoetin alfa 3 times weekly /once weekly|DRUG: Epoetin alfa once weekly|DRUG: Epoetin alfa once every two weeks |
| Outcome Measures: | Primary: Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22, The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included in calculating the average Hb during the last 8 weeks of treatment through Week 22., From baseline through Week 22 | Secondary: Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by Week 9, The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Hb increase is defined as the post-baseline Hb level minus the baseline Hb level., From baseline to Week 9 | Other: Participants Who Exceeded a Hb Concentration of 11.9 g/dL During First 22 Weeks of Treatment, The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. participants who exceed a Hb value of 11.9 g/dL at least once were included in the numerator of the percentage calculation., From baseline to Week 22|Maximum Hb Concentration (g/dL) During First 22 Weeks of Treatment, The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. A maximum Hb observation was identified for each participant during the first 22 weeks of treatment., From baseline to Week 22|Participants Who Met or Exceeded Hb Rate of Rise >=1.0 g/dL/2 Weeks During First 22 Weeks of Treatment, Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation., From baseline to Week 22|Participants Who Met or Exceeded Hb Rate of Rise >=1.5 g/dL/2 Weeks During First 22 Weeks of Treatment, Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.5 g/dL/2 weeks at least once were included in the numerator of the percentage calculation., From baseline to Week 22|Particpants Who Met or Exceeded Hb Rate of Rise >=2.0 g/dL/2 Weeks During First 22 Weeks of Treatment, Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 2.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation., From baseline to Week 22 |
| Sponsor/Collaborators: | Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 375 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2006-09 |
| Completion Date: | 2008-02 |
| Results First Posted: | 2010-02-08 |
| Last Update Posted: | 2014-05-07 |
| Locations: | Glendale, Arizona, United States|Tempe, Arizona, United States|Chula Vista, California, United States|Long Beach, California, United States|Los Angeles, California, United States|Lynwood, California, United States|Riverside, California, United States|San Diego, California, United States|Visalia, California, United States|Whittier, California, United States|Yuba City, California, United States|Colorado Springs, Colorado, United States|Lakewood, Colorado, United States|Thornton, Colorado, United States|Lauderdale Lakes, Florida, United States|Miami, Florida, United States|Orlando, Florida, United States|Palm Beach Gardens, 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|Carrollton, Georgia, United States|Macon, Georgia, United States|Statesboro, Georgia, United States|Chicago, Illinois, United States|Peoria, Illinois, United States|Baltimore, Maryland, United States|Bethesda, Maryland, United States|Methuen, Massachusetts, United States|Plymouth, Massachusetts, United States|Flint, Michigan, United States|Hackensack, New Jersey, United States|Old Bridge, New Jersey, United States|Vineland, New Jersey, United States|Albuquerque, New Mexico, United States|Great Neck, New York, United States|New Hartford, 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|Maumee, Ohio, United States|Doylestown, Pennsylvania, United States|Easton, Pennsylvania, United States|Erie, Pennsylvania, United States|Lancaster, Pennsylvania, United States|Wynnewood, Pennsylvania, United States|Bamberg, South Carolina, United States|Orangeburg, South Carolina, United States|Sumter, South Carolina, United States|Dyersburg, Tennessee, United States|Arlington, Texas, United States|Houston, Texas, United States|San Antonio, Texas, United States|Chesapeake, Virginia, United States|Fairfax, Virginia, United States|Hampton, Virginia, United States|Richmond, Virginia, United States|Tacoma, Washington, United States|Caguas, Puerto Rico |
| URL: | https://clinicaltrials.gov/show/NCT00440557 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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