| Trial ID: | L1397 |
| Source ID: | NCT02492620
|
| Associated Drug: |
Ferric Citrate
|
| Title: |
Ferric Citrate for the Transition From CKD Stage 4/5 to CKD Stage 5D
|
| Acronym: |
05D
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|Hyperphosphatemia|Iron Deficiency Anemia|Renal Insufficiency
|
| Interventions: |
DRUG: Ferric Citrate
|
| Outcome Measures: |
Primary: Serum phosphate value prior to starting renal replacement therapy, baseline | Secondary: Serum hemoglobin prior to starting renal replacement therapy, baseline|Serum transferrin saturation prior to starting renal replacement therapy, baseline|Serum fibroblast growth factor 23 prior to starting renal replacement therapy, baseline | Other: Cumulative dose of erythropoietin analog, Total dose of ESA received in units from baseline visit to 90 days post renal replacement, Baseline visit to 90 days after starting renal replacement therapy|Cumulative dose of intravenous iron, Total dose of intravenous iron received in units from baseline visit to 90 days post renal replacement, Baseline visit to 90 days after starting renal replacement therapy
|
| Sponsor/Collaborators: |
Sponsor: Denver Nephrologists, P.C. | Collaborators: Keryx Biopharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-03
|
| Completion Date: |
2017-11
|
| Results First Posted: |
|
| Last Update Posted: |
2018-08-01
|
| Locations: |
Denver Nephrologists, P.C., Denver, Colorado, 80230, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02492620
|
