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Clinical Trial Details

Trial ID: L1673
Source ID: NCT06115421
Associated Drug: Roxadustat
Title: Effect of Low Doses of Hypoxia-inducible Factor- Prolyl Hydroxylase Enzyme Inhibitor Plus Iron in the Treatment of Anemia in Dialysis-dependent Chronic Kidney Disease Patients
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Anemia in Dialysis-dependent CKD Patients
Interventions: DRUG: Roxadustat
Outcome Measures: Primary: Changes in hemoglobin level from baseline, HB g/dl, 3 months|Iron metabolism parameters change from the baseline, serum iron µg/ml , ferritin µg/l, Total Iron Binding Capacity µg/ml (TIBC) levels, and transferrin saturation (TSAT)%, 3 months|Safety profile, adverse events will be reported using a pre-prepared checklist, 3 months | Secondary: Time to achieve and maintain HB target, desired level (HB) 10-12 g/dL, 3 months|The need for rescue therapy, 1. For the Roxadustat-treated participants (intervention arm) rescue therapy is defined as, red blood cell (RBC) transfusion or erythropoiesis-stimulating agent (ESA). 2. For erythropoiesis-stimulating agents (ESA) (control arm) rescue therapy is defined as RBC transfusion, 3 months|The minimum effective dose in combination with iron is needed to achieve the HB target., 3 months|Change in hepcidin level in the intervention group, 3 months|Change in the Quality of Life (QoL) of the patients after the completion of the study period, Arabic-translated reliable and valid version of the Kidney Disease Quality of Life questionnaire (KDQOL-36) for patients with CKD, 3 months
Sponsor/Collaborators: Sponsor: Alexandria University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 72
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-24
Completion Date: 2024-05
Results First Posted:
Last Update Posted: 2024-02-01
Locations: Alexandria University, Alexandria, Egypt
URL: https://clinicaltrials.gov/show/NCT06115421