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Clinical Trial Details

Trial ID: L0586
Source ID: NCT04655027
Associated Drug: Roxadustat
Title: A Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04655027/results
Conditions: Anemia of Chronic Kidney Disease
Interventions: DRUG: Roxadustat|DRUG: rHuEPO
Outcome Measures: Primary: Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours), The main effect of roxadustat versus rHuEPO on GI iron absorption was evaluated., From Baseline (Day 1) to Day 15 | Secondary: Difference From Baseline to Day 15 in Area Under Curve (AUC) of Iron Absorption (0-3 Hours), The effect and interaction with key baseline variables of roxadustat versus rHuEPO on iron absorption was assessed., From Baseline (Day 1) to Day 15|Difference From Baseline to Day 15 in Serum Iron, The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: serum iron was assessed., From baseline (Day 1) to Day 15|Difference From Baseline to Day 15 in Ferritin, The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Ferritin was assessed., From baseline (Day 1) to Day 15|Difference From Baseline to Day 15 in Total Iron Binding Capacity (TIBC), The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: TIBC was assessed., From baseline (Day 1) to Day 15|Relative Difference From Baseline to Day 15 in Transferrin Saturation (TSAT), The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: TSAT (fraction of TIBC) was assessed., From baseline (Day 1) to Day 15|Difference From Baseline to Day 15 in Transferrin, The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Transferrin was assessed., From baseline (Day 1) to Day 15|Difference From Baseline to Day 15 in Soluble Transferrin Receptor, The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Soluble transferrin receptor was assessed., From baseline (Day 1) to Day 15|Difference From Baseline to Day 15 in Hepcidin, The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of Hepcidin was assessed., From baseline (Day 1) to Day 15|Number of Subjects With Adverse Events (AEs), AEs as variables of safety was assessed., From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Parexel
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 25
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-02-22
Completion Date: 2021-10-12
Results First Posted: 2024-04-22
Last Update Posted: 2024-04-22
Locations: Research Site, Baotou, 14010, China|Research Site, Beijing, 100029, China|Research Site, Beijing, 100044, China|Research Site, Beijing, 100730, China|Research Site, Guangzhou, 510180, China|Research Site, Jinan, 250012, China|Research Site, Shenyang, 110001, China|Research Site, Wuhan, 430022, China
URL: https://clinicaltrials.gov/show/NCT04655027