ESA Hyporesponsiveness in Hemodialysis Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
This prospective cohort study aims to evaluate the development, persistence, and recovery of erythropoiesis-stimulating agent (ESA) hyporesponsiveness among patients receiving maintenance hemodialysis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
ESRD/CKD G5D receiving maintenance hemodialysis.
Hemodialysis ≥3 months before enrollment.
Receiving ESA therapy for anemia.
Disqualifiers
Active malignancy.
Hematological malignancy.
Known hemoglobinopathy causing anemia.
Recent blood transfusion, e.g. within 3 months before enrollment.
Trial population
Adult patients with end-stage renal disease receiving maintenance hemodialysis at the Hemodialysis Center, Assiut University Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Single cohort: Maintenance Hemodialysis Patients
Trial outcomes
Primary outcomes
1
Incidence of new-onset ESA hyporesponsiveness
Proportion of patients who develop new-onset ESA hyporesponsiveness, defined as erythropoietin resistance index (ERI) \> 15.4 during the 12-month follow-up.
Time frame
12 monthsSecondary outcomes
1
Proportion of patients with persistent ESA hyporesponsiveness
Proportion of patients with ESA hyporesponsiveness (ERI \> 15.4) persisting for more than 4 months.
Time frame
12 months2
Proportion of patients who recover from ESA hyporesponsiveness
Proportion of patients who recover from ESA hyporesponsiveness (ERI ≤ 15.4) during follow-up.
Time frame
12 months3
Mean erythropoietin resistance index
Mean erythropoietin resistance index (ERI) calculated as weekly ESA dose (IU/week) / \[body weight (kg) × hemoglobin (g/dL)\].
Time frame
Baseline and at 12 months4
Mean serum ferritin
Mean serum ferritin level in ng/mL.
Time frame
Baseline and at 12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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