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Clinical Trial Details

Trial ID: L0741
Source ID: NCT03055598
Associated Drug: Ferric Citrate
Title: Ferric Citrate in ESRD Pilot Project
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: End Stage Renal Disease|Chronic Kidney Diseases
Interventions: DRUG: Ferric Citrate
Outcome Measures: Primary: change in average weekly ESA dose determination from baseline to day 90, determine change in average dose of ESA use when using Auryxia, day 90|change in mean serum iron from baseline to day 90, assess change in mean serum iron while using Auryxia, day 90|change in mean ferritin from baseline to day 90, assess change in mean ferritin while using Auryxia, day 90 | Secondary: change in average weekly ESA dose determination, determine change in average dose of ESA use when using Auryxia, baseline, day 30, day 60|change in mean serum iron, assess change in mean serum iron while using Auryxia, baseline, day 30, day 60|change in mean ferritin, assess change in mean ferritin while using Auryxia, baseline, day 30, day 60|TSAT value, values if less than 30% to greater than 30% to determine effectiveness, baseline, day 30, day 60, day 90|hemoglobin value, elevated serum ferritin (\>1000 ng/ml) to determine effectiveness, baseline, day 30, day 60, day 90|Kidney Disease Quality of Life (KDQOL)-36 energy score, KDQOL-36 energy score to determine overall quality of life, Baseline and 90 days|KDQOL-36 fatigue score, KDQOL-36 fatigue score to determine overall quality of life, Baseline and 90 days|KDQOL-36 depression score, KDQOL-36 depression score to determine overall quality of life, Baseline and 90 days|Number of participants alive or dead (Survival status) at 90 days, Measured by death (yes/no) and date, at 90 days
Sponsor/Collaborators: Sponsor: Sreedhar Mandayam | Collaborators: Keryx Biopharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2017-05-11
Completion Date: 2020-02
Results First Posted:
Last Update Posted: 2019-04-17
Locations: Harris Health System - Riverside Dialysis Center, Houston, Texas, 77004, United States|US Renal Care- Scott Street, Houston, Texas, 77021, United States
URL: https://clinicaltrials.gov/show/NCT03055598