| Trial ID: | L1520 |
| Source ID: | NCT04649411
|
| Associated Drug: |
Ferric Citrate
|
| Title: |
Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
|
| Interventions: |
DRUG: ferric citrate|DRUG: standard of care
|
| Outcome Measures: |
Primary: Number of Participants with Serious and Non-serious Treatment-emergent Adverse Events, up to Week 28|Number of Participants with Clinically Significant Laboratory Abnormalities or Changes in Laboratory Results, up to Week 24|Number of Participants with Treatment-emergent Adverse Events Leading to the Discontinuation of Ferric Citrate, up to Week 28 | Secondary: Change from Baseline in Hemoglobin to Week 24/Early Termination Visit, Baseline; Week 24|Change from Baseline in Transferrin Saturation (TSAT) to Week 24/Early Termination Visit, Baseline; Week 24|Change from Baseline in Ferritin to Week 24/Early Termination Visit, Baseline; Week 24|Change from Baseline in Serum Phosphorus to Week 24/Early Termination Visit, Baseline; Week 24|Change from Baseline in Calcium to Week 24/Early Termination Visit, Baseline; Week 24|Change from Baseline in Bicarbonate to Week 24/Early Termination Visit, Baseline; Week 24
|
| Sponsor/Collaborators: |
Sponsor: Keryx Biopharmaceuticals
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2025-01
|
| Completion Date: |
2027-03
|
| Results First Posted: |
|
| Last Update Posted: |
2023-10-23
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| Locations: |
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| URL: |
https://clinicaltrials.gov/show/NCT04649411
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