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Clinical Trial Details

Trial ID: L0687
Source ID: NCT02268994
Associated Drug: Ferric Citrate
Title: KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02268994/results
Conditions: Anemia of Chronic Kidney Disease
Interventions: DRUG: ferric citrate|DRUG: Placebo
Outcome Measures: Primary: Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period, Efficacy analyses were performed for the Intention-to-treat (ITT) population, the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug, and had at least 1 post-baseline laboratory assessment during the randomized period., Week 16 | Secondary: Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline, The difference of Hgb at 16 weeks compared to the Hgb value at the time of study entry., Baseline and week 16|Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline, The difference of TSAT at 16 weeks compared to the TSAT value at the time of study entry was averaged., Baseline and week 16|Mean Change in Ferritin at the End of 16 Weeks Minus Baseline, The difference of ferritin at 16 weeks compared to the ferritin value at the time of study entry., Baseline and week 16|Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb), Proportion of subjects that continued to maintain an increase in Hgb over a 4 week period, provided they had an increase of at least 1.0 g/dL during that 4-week period, Week 16|Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline, The difference of serum phosphate at 16 weeks compared to the serum phosphate value at the time of study entry., Baseline and week 16
Sponsor/Collaborators: Sponsor: Keryx Biopharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 234
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-10
Completion Date: 2016-01
Results First Posted: 2018-02-22
Last Update Posted: 2018-03-22
Locations: AKDHC Medical Research Services, LLC, Phoenix, Arizona, 85027, United States|Southwest Kidney Institute, Tempe, Arizona, 85284, United States|California Renal Research, Glendale, California, 91204, United States|Southern California Medical Research Center, La Palma, California, 90623, United States|Academic Medical Research Institute, Inc, Los Angeles, California, 90022, United States|Apex Research of Riverside, Riverside, California, 92505, United States|Capital Nephrology Medical Group, Sacramento, California, 95825, United States|La Jolla Clinical Research, Inc, San Diego, California, 92103, United States|California Institute of Renal Research, San Diego, California, 92123, United States|Denver Nephrology, Denver, Colorado, 80230, United States|Creekside Medical Research, DeLand, Florida, 32123, United States|Riverside Clinical Research, Edgewater, Florida, 32132, United States|Pines Clinical Research, Inc, Pembroke Pines, Florida, 33028, United States|Kidney Care Associates, LLC, Augusta, Georgia, 30909, United States|Renal Physicians of Georgia, PC, Macon, Georgia, 31217, United States|Pacific Renal Research Institute, Meridian, Idaho, 83642, United States|Advanced Renal Care, Evergreen Park, Illinois, 60805, United States|Kansas Nephrology Research Institute, Wichita, Kansas, 67214, United States|Renal Associates of Baton Rouge, Baton Rouge, Louisiana, 70808, United States|Western New England Renal & Transplant Associates, Springfield, Massachusetts, 01107, United States|Renaissance Renal Research, Detroit, Michigan, 48236, United States|Michigan Kidney Consultants, PC, Pontiac, Michigan, 48341, United States|Clinical Research Consultants, Kansas City, Missouri, 64111, United States|Lincoln Nephrology & Hypertension, Lincoln, Nebraska, 68105, United States|Sierra Nevada Nephrology Asoociates, Reno, Nevada, 89519, United States|Mountain Kidney & Hypertension Associates, Asheville, North Carolina, 28801, United States|Metrolina Nephrology, Charlotte, North Carolina, 28204, United States|Research Management, Inc, Austin, Texas, 78732, United States|Research Management, Inc., Austin, Texas, 78758, United States|TAD Clinical Research, Lufkin, Texas, 75904, United States|Kidney & Hypertension Specialists, San Antonio, Texas, 78207, United States|Clinical Advancement Center, San Antonio, Texas, 78215, United States|San Antonio Kidney Disease Center, San Antonio, Texas, 78229, United States|Mendez Center for Clinical Research, Alexandria, Virginia, 22304, United States|Nephrology Associates of Northern VA, Inc., Fairfax, Virginia, 22033, United States|Peninsula Kidney Associates, Hampton, Virginia, 23666, United States
URL: https://clinicaltrials.gov/show/NCT02268994

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress