Clinical Trial Details
| Trial ID: | L1086 |
| Source ID: | NCT01074125 |
| Associated Drug: | Ferric Citrate |
| Title: | A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01074125/results |
| Conditions: | Hyperphosphatemia|End-Stage Renal Disease |
| Interventions: | DRUG: ferric citrate |
| Outcome Measures: | Primary: Change in Serum Phosphorus From Baseline to End of Treatment, Mean change from baseline was calculated separately for each treatment arm (LOCF), Baseline and day 28 | Secondary: Pairwise Comparison of the Mean Change in Serum Phosphorus From Baseline to the End of Treatment, Mean change from baseline was calculated separately for each treatment arm. Only subjects that have both baseline and end of treatment serum phosphorus scores were analyzed for this outcome., Baseline and day 28|Proportion of Patient With a Serum Phosphorus ≤5.5 mg/dL at the End of Treatment, proportion was calculated separately for each treatment arm, Baseline and day 28 |
| Sponsor/Collaborators: | Sponsor: Keryx Biopharmaceuticals | Collaborators: Collaborative Study Group (CSG) |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 154 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2010-05 |
| Completion Date: | 2010-11 |
| Results First Posted: | 2014-12-04 |
| Last Update Posted: | 2014-12-04 |
| Locations: | Western Nephrology, Westminster, Colorado, 80031, United States|Pines Clinical Research, Inc., Pembroke Pines, Florida, 33028, United States|Kidney Care Associates, LLC, Augusta, Georgia, 30901, United States|Circle Medical Management, Chicago, Illinois, 60607, United States|Western New England Renal & Transplant Associates, Springfield, Massachusetts, 01107, United States|Brookdale Physician's Dialysis Associates, Brooklyn, New York, 11212, United States|DCI, Cincinnati, Ohio, 45206, United States|Cleveland Clinical Foundation Fresenius East (Fairhill), Cleveland, Ohio, 44104, United States|The Ohio State University Cramblett Medical Clinic, Columbus, Ohio, 43210, United States|Southeast Renal Research Institute, Chattanooga, Tennessee, 37404, United States|Nephrology Associates, PC, Nashville, Tennessee, 37205, United States|Meharry Medical College Clinical Research Center, Nashville, Tennessee, 37208, United States|Vanderbilt University Medical Center Clinical Trials Center, Nashville, Tennessee, 37232-1371, United States|Kidney Associates, Houston, Texas, 77030, United States|Centre Point Dialysis, West Allis, Wisconsin, 53214, United States|RCMI- Clinical Research Center Medical Sciences Campus University of Puerto Rico, Rio Piedras, 00936-5067, Puerto Rico |
| URL: | https://clinicaltrials.gov/show/NCT01074125 |
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