this study aims to : 1. To compare the efficacy of combining low doses of Roxadustat Hypoxia-Inducible Factor (HIF)-Prolyl Hydroxylase (PHD) inhibitor and iron versus standard treatment with erythropoietin-stimulating agents (ESA) in the treatment of anemia as a complication of chronic kidney disease (CKD) among dialysis-dependent patients. 2. To emphasize the safety profile of low doses of Roxadustat HIF-PHD. 3. To assess changes in the quality of life of patients with kidney disease before and after treatment.
1- The Ethics Committee of Alexandria University approved conducting the research in April 2023. 2\. Informed consent will be obtained from all patients to participate in the trial after a thorough explanation of the nature of the study 3. Dialysis-dependent CKD patients with anemia will be recruited from Alexandria University Hospital \&/or private hospitals (if any). 4\. Study design: two-arm open-label non randomized active control study 5. Sample size was calculated using G\*Power 3, a minimal total hypothesized sample size of 72 eligible adult Dialysis dependent CKD patients (DD -CKD) with anemia \[ 36 per group\] is needed; taking into consideration 95% confidence level, the effect size of 0.6. and 80% power using a t-test. 6\. Three phases will comprise the trial: a screening phase that lasts from 2-4 weeks, a therapy phase that lasts for up to 12 weeks, and a follow-up phase that lasts 2-4 weeks. After obtaining informed consent, during visit 1, we will check the inclusion and exclusion criteria At each visit, the patient's well-being and the occurrence of any Drug-Related Adverse effects (DRAs) will be monitored accurately. 7\. The Arabic-translated reliable and valid version of the Kidney Disease Quality of Life questionnaire (KDQOL-36) for patients with CKD will be completed with patients during the interview at the baseline and after fulfilling the whole study period 8. The collected data will be subjected to statistical analysis by the use of suitable techniques to achieve the objectives of the study
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHIs)
Alexandria University
Alexandria, Egypt
RECRUITINGChanges in hemoglobin level from baseline
HB g/dl
Time frame: 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)%
Time frame: 3 months
Safety profile
adverse events will be reported using a pre-prepared checklist
Time frame: 3 months
Time to achieve and maintain HB target
desired level (HB) 10-12 g/dL
Time frame: 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
Time frame: 3 months
The minimum effective dose in combination with iron is needed to achieve the HB target.
Time frame: 3 months
Change in hepcidin level in the intervention group
Time frame: 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
Time frame: 3 months
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