Comparison Between Darbapoeitin Alpha and Roxadustat in CKD-related Anemia

Ain Shams University35 enrolled

Overview

Anemia is a common and debilitating complication of end-stage kidney disease (ESKD) that is associated with reduced quality of life and high morbidity and mortality. ESKD-related anemia is associated with many adverse comorbidities and outcomes; however, normalizing the levels of hemoglobin proved to be insignificant in improving most adverse outcomes. This study aims to evaluate the real-world effectiveness and safety of an ESA and a HIF-PHI in patients with CKD-related anemia.

Anemia is a common and debilitating complication of chronic kidney disease (CKD), affecting a significant proportion of patients worldwide. It is approximately twice as prevalent among ESKD patients compared to the general population. The prevalence of anemia increases across the advancing stages of CKD, with estimates anywhere from 7% to \>50%. Study Design: This prospective observational cohort study involved 35 hemodialysis patients at Electricity Hospital, Almaza, Cairo, who were randomly treated with either Roxadustat or Darbepoetin Alfa over 12 weeks. The study aims to assess whether Roxadustat use in the management of ESKD-related anemia results in improved iron profile and reduced iron needs compared with traditional treatment for ESKD-related anemia.

Study Type

OBSERVATIONAL

Enrollment

Conditions

CKD Anemia CKD Anemia in Stable Dialysis Patients

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * End-stage kidney disease-related anemia * Hemodialysis-related anemia * The mean of the two most recent Hemoglobin values before randomization was 10.5mg/dL or less Exclusion Criteria: * ESA treatment 12 weeks before transfusion * RBC transfusion 8 weeks before transfusion * IV iron transfusion 6 weeks before transfusion * Known history of myelodysplastic syndrome * Known history of multiple myeloma * Known history of hereditary hematologic diseases * Active bleeding or any cause of anemia unrelated to CKD * NYHA Class III or IV congestive heart failure * Liver disease, defined as ALT or AST 3x ULN or greater, or total bilirubin 1.5x ULN or greater * Prior organ transplant

Locations (1)

Electricity Hospital

Cairo, Egypt

Outcomes

Primary Outcomes

Change in Iron profile

The study aims to assess whether Roxadustat usage in the management of CKD-related anemia results in improving iron profile and reducing iron needs compared with traditional treatment for CKD-related anemia.

Time frame: 12 weeks

Secondary Outcomes

Kidney Functions

The study compares the changes in serum creatinine in patients taking roxadustat in comparison to darbepoetin alfa

Time frame: 12 weeks

Change in hemoglobin levels

Hemoglobin levels are measured at baseline and at the end of the 12 weeks

Time frame: 12 weeks

RBC transfusion rate

Time frame: 12 weeks

The need of IV iron

Time frame: 12 weeks

Data from ClinicalTrials.gov

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