| Trial ID: | L0712 |
| Source ID: | NCT04543812
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| Associated Drug: |
Ferric Citrate
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| Title: |
PBF-1681 (Ferric Citrate) for the Treatment of IDA in Patients With NDD-CKD
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
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| Conditions: |
Anemia of Chronic Kidney Disease
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| Interventions: |
DRUG: Ferric citrate|DRUG: Placebo
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| Outcome Measures: |
Primary: The proportion of subjects achieving an increase in Hgb of ≥1.0 g/dL at any time point between baseline and the end of the 16-week Randomized Period., Efficacy analyses were performed for the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug or placebo, and had at least 1 post-baseline laboratory assessment during the randomized period., 16 weeks | Secondary: Hemoglobin (Hgb), The mean change from baseline to the end of the Randomized Period in Hgb., 16 weeks|Transferring saturation (TSAT), The mean change from baseline to the end of the Randomized Period in TSAT., 16 weeks|Ferritin, The mean change from baseline to the end of the Randomized Period in ferritin., 16 weeks|Serum Phosphate, The mean change from baseline to the end of the Randomized Period in serum phosphate., 16 weeks|Sustained increase in Hgb of ≥0.75 g/dL, The proportion of subjects achieving a sustained increase in Hgb of ≥0.75 g/dL from baseline over any 4-week interval during the Randomization Period., 16 weeks | Other: Serum calcium, The mean change from baseline to the end of the Randomized Period in serum calcium., 16 weeks|Serum bicarbonate, The mean change from baseline to the end of the Randomized Period in serum bicarbonate., 16 weeks|Serum iron, The mean change from baseline to the end of the Randomized Period in serum iron., 16 weeks|Unsaturated iron binding capacity (UIBC), The mean change from baseline to the end of the Randomized Period in UIBC., 16 weeks|Total iron binding capacity (TIBC), The mean change from baseline to the end of the Randomized Period in TIBC., 16 weeks|Hematocrit, The mean change from baseline to the end of the Randomized Period in hematocrit., 16 weeks|Intact parathyroid hormone (iPTH), The mean change from baseline to the end of the Randomized Period in iPTH., 16 weeks|Fibroblast growth factor 23 (intact and C-terminal), The mean change from baseline to the end of the Randomized Period in FGF23 (intact and C-terminal)., 16 weeks|Serum aluminum, The mean change from baseline to the end of the Randomized Period in serum aluminum., 16 weeks|Sustained increase in Hgb, The proportion of subjects achieving a sustained increase in Hgb of ≥0.75 g/dL from baseline over any 4-week interval during the Randomized Period, provided that an increase in Hgb of ≥1.0 g/dL had occurred during that 4-week interval, 16 weeks|Increase in Hgb of ≥1.0 g/dL, Time (in days) to first increase in Hgb of ≥1.0 g/dL from baseline., 16 weeks
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| Sponsor/Collaborators: |
Sponsor: Panion & BF Biotech Inc.
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
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| Enrollment: |
141
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2020-10-14
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| Completion Date: |
2022-12-16
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| Results First Posted: |
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| Last Update Posted: |
2023-03-09
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| Locations: |
Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, 80756, Taiwan|Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital, Kaohsiung, 83301, Taiwan|Division of Nephrology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital, Keelung, 20401, Taiwan|Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital, New Taipei City, 22060, Taiwan|Division of Nephrology, Department of Internal Medicine, China Medical University Hospital, Taichung, 40433, Taiwan|Division of Nephrology, Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital, Taipei county, 23561, Taiwan|Department of Integrated Diagnostics and Therapeutics, National Taiwan University Hospital, Taipei, 10002, Taiwan|Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital, Taipei, 11217, Taiwan
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| URL: |
https://clinicaltrials.gov/show/NCT04543812
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