Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0775
Source ID: NCT01693029
Associated Drug: Hx575 Epoetin Alfa
Title: Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
Acronym: ACCESS
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01693029/results
Conditions: Anemia|Chronic Kidney Disease (CKD)
Interventions: DRUG: HX575 epoetin alfa|DRUG: US-licensed epoetin alfa
Outcome Measures: Primary: Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28), Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study ., Week -4 to Day1 and Week 21-28|Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28), Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study ., Week -4 to Day1 and Week 21-28 | Secondary: Mean Weekly Dose During Evaluation Period (Week 21-28), Mean weekly study drug dose during evaluation period (Week 21-28), Week 21-28|Incidence of Antibody Formation Against Epoetin, Number of patients with positive antidrug antibody (ADA) finding at any time during their treatment period. Count includes 2 patients (1 in each arm) that already had a positive ADA Baseline finding. ADA testing performed by by Radio-Immuno-Precipitation assay. No patient developed neutralizing antibodies., 52 weeks
Sponsor/Collaborators: Sponsor: Sandoz
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 435
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-09
Completion Date: 2015-03
Results First Posted: 2017-05-12
Last Update Posted: 2017-07-02
Locations: Southwestern Kidney Institute, Tempe, Arizona, 85284, United States|North America Research Institute, Azusa, California, 91702, United States|Pegasus Dialysis, LLC, Bakersfield, California, 93308, United States|Central Nephrology Medical Group, Bakersfield, California, 93309, United States|California Institute of Renal Research, Chula Vista, California, 91910, United States|Renal Consultants Medical Group, Granada Hills, California, 91344, United States|Angel Kidney Care of Inglewood Dialysis Center, Inglewood, California, 90301, United States|California Institute of Renal Research, La Mesa, California, 91942, United States|Alliance Research Centers, Laguna Hills, California, 92653, United States|Academic Medical Research Institute, Los Angeles, California, 90022, United States|Ronald Reagan Medical Center, Department of Pharmaceutical Services, Drug Information Center, Los Angeles, California, 90025, United States|Tower Nephrology Medical Group, Los Angeles, California, 90048, United States|St Vincent Dialysis Center, Los Angeles, California, 90057, United States|Kidney Research Center, Lynwood, California, 90262, United States|Valley Renal Medical Group, Northridge, California, 91324, United States|Ontario Dialysis, Inc., Ontario, California, 91762, United States|Apex Research of Riverside, Riverside, California, 92505, United States|Capital Nephrology Medical Group, Sacramento, California, 95825, United States|California Institute of Renal Research, San Diego, California, 92111, United States|La Jolla Clinical Research, Inc., San Diego, California, 92154, United States|North America Research Institute, San Dimas, California, 91773, United States|American Institute of Research, Whittier, California, 90603, United States|South Florida Nephrology, Coral Springs, Florida, 33071, United States|Pines Clinical Research Inc., Hollywood, Florida, 33020, United States|Genesis Clinical Research Corporation, Tampa, Florida, 33614, United States|Atekha Nephrology Clinic LLC, Statesboro, Georgia, 30458, United States|Four Rivers Clinical Research, Incorporated, Paducah, Kentucky, 42003, United States|Northwest Louisana Nephrology, Shreveport, Louisiana, 71101, United States|Germantown Dialysis, Germantown, Maryland, 20874, United States|Fresenius Management Services, Inc., Farmington, Missouri, 63640, United States|Creighton University, Omaha, Nebraska, 68131, United States|Kidney Specialists of Southern Nevada, Las Vegas, Nevada, 89106, United States|Seacoast Kidney and Hypertension Specialist, PLLC, Portsmouth, New Hampshire, 03801, United States|Renal Medicine Associates, Albuquerque, New Mexico, 87109, United States|New York Hospital Queens, Fresh Meadows, New York, 11365, United States|Metrolina Nephrology Associates, PA, Charlotte, North Carolina, 28207, United States|Boice-Willis Clinic, PA, Rocky Mount, North Carolina, 27804, United States|Southeastern Dialysis Center, Wilmington, North Carolina, 28401, United States|Northeast Clinical Research Centers, Inc., Bethlehem, Pennsylvania, 18017, United States|Delaware Valley Nephrology and Hypertension Associates, PC, Philadelphia, Pennsylvania, 19118, United States|Rhode Island Hospital, Providence, Rhode Island, 02903, United States|Palmetto Nephrology PA, Orangeburg, South Carolina, 29118, United States|SC Nephrology & Hypertension Center, Inc., Orangeburg, South Carolina, 29118, United States|Knoxville Kidney Center PLLC, Knoxville, Tennessee, 37923, United States|Research Management, Inc., Austin, Texas, 78756, United States|Gamma Clinical Research Institute, Edinburg, Texas, 78539, United States|Nephrology, P.A., Houston, Texas, 77030, United States|Clinical Trial Network, Houston, Texas, 77074, United States|Renal Associates, PA, San Antonio, Texas, 78215-2035, United States|Southern Utah Kidney and Hypertension Center, Saint George, Utah, 84770, United States|Mendez Center For Clinical Research, LLC, Alexandria, Virginia, 22304, United States|West Virginia University Hospitals and Clinic, Morgantown, West Virginia, 26506, United States
URL: https://clinicaltrials.gov/show/NCT01693029

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress