Logo 1 Logo 2

Clinical Trial Details

Trial ID: L1635
Source ID: NCT01736397
Associated Drug: Ferric Citrate
Title: Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01736397/results
Conditions: Iron Deficiency|Iron Deficiency Anemia
Interventions: DRUG: Ferric Citrate|DRUG: Placebo
Outcome Measures: Primary: Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment, The difference in TSAT between the value at the end of treatment (week 12) minus the baseline measurement., 12 Weeks|Change in Serum Phosphorus Levels From Baseline to End of Treatment, The difference in serum phosphorus between the value at the end of treatment (week 12) minus the baseline measurement., 12 Weeks | Secondary: Change in Ferritin Levels From Baseline to End of Treatment, The difference in ferritin levels between the value at the end of treatment (week 12) minus the baseline measurement., 12 Weeks|Change in Hemoglobin Levels From Baseline to End of Treatment, The difference in hemoglobin levels between the value at the end of treatment (week 12) minus the baseline measurement., 12 Weeks
Sponsor/Collaborators: Sponsor: Keryx Biopharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 149
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-11
Completion Date: 2013-12
Results First Posted: 2017-10-20
Last Update Posted: 2017-10-20
Locations: Tempe, Arizona, United States|La Mesa, California, United States|Sacramento, California, United States|Denver, Colorado, United States|Edgewater, Florida, United States|Miami, Florida, United States|Meridian, Idaho, United States|Evergreen Park, Illinois, United States|Bethesda, Maryland, United States|Springfield, Massachusetts, United States|Detroit, Michigan, United States|Pontiac, Michigan, United States|Reno, Nevada, United States|Great Neck, New York, United States|Mineola, New York, United States|Asheville, North Carolina, United States|Wilmington, North Carolina, United States|Orangeburg, South Carolina, United States|Houston, Texas, United States|San Antonio, Texas, United States
URL: https://clinicaltrials.gov/show/NCT01736397