Skip to content

Evaluation of Erythropoietin Therapy in Patients With End-Stage Kidney Disease on Regular Hemodialysis: Hemoglobin Outcomes, and Metabolic Syndrome as a Risk Factor for Erythropoietin Resistance

Evaluation of Erythropoietin Therapy in Patients With End-Stage Kidney Disease on Regular Hemodialysis: Hemoglobin Outcomes, and Metabolic Syndrome as a Risk Factor for Erythropoietin Resistance

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06983756
Enrollment
66
Registered
2025-05-21
Start date
2025-06-01
Completion date
2026-01-01
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erythropoietin Resistant Anemia (EPO Resistant Anemia)

Brief summary

The primary aim of this study is to investigate the association between metabolic syndrome and erythropoietin resistance in patients with End-Stage Kidney Disease (ESKD).

Detailed description

Chronic kidney disease (CKD) is a common condition that has significant implications for patients' health and healthcare budgets. CKD is a major contributor to morbidity and mortality across the globe. The incidence and prevalence of CKD are rising steadily all over the world. Along with many adverse effects on different body organs, CKD and end-stage kidney disease (ESKD) are associated with body will beting and malnutrition. Patients with ESKD require maintenance hemodialysis (MHD) to sustain their life. Patients with chronic kidney disease (CKD) have a relatively deficient erythropoietin (EPO) production, and this is the main cause of anemia in this group. In its severe form, anemia decreases quality of life and increases the risk of cardiovascular diseases and mortality in dialysis patients, so the implementation of prevention and control measures is recommended \[4\]. Erythropoiesis-stimulating agents (ESAs) are generally used to control anemia and reduce the need for blood transfusions in patients with CKD. ESA resistance or hyporesponsiveness occurs when the patient does not reach the desired serum hemoglobin (Hb) concentration even with the use of ESA at doses higher than usual or when increasingly higher doses are necessary to maintain the recommended Hb concentration. The main causes of EPO resistance are iron deficiency, chronic inflammation, inadequate dialysis, hyperparathyroidism, hemolysis, vitamin B12, and folate deficiency. Observational studies have shown that nutritional status is associated with EPO resistance in HD patients, mainly because of malnutrition-inflammation status. While treating anemic patients with αEPO can increase hemoglobin levels to recommended values and decrease complications in hemodialysis patients, the treatment of anemia with an ESA can increase the risk of mortality; high dosages of the ESA and treatment resistance are the primary factors for this outcome. Thus, it is important to determine which factors limit the ability of αEPO to correct anemia in hemodialysis patients so that treatment can be optimized.

Interventions

DRUGErythropoietin

EPO resistance

Sponsors

Fayoum University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Patients (and replacements) will be randomly selected by a raffle. * All participants should be 18 years of age or older and agree to participate in the study after due clarification. * Patients with end stage kidney disease (ESKD) on regular hemodialysis for more than 3 months.

Exclusion criteria

* \- Patients with neoplasm, severe cardiovascular, cerebrovascular and liver diseases. * Females with polycystic ovarian syndrome, those on hormonal replacement therapy and pregnant women. * Patients with infection or autoimmune diseases.

Design outcomes

Primary

MeasureTime frameDescription
HB6 monthHemoglobin in blood

Contacts

Primary ContactNada Elsayed, Bachelor
ne1189@fayoum.edu.eg01000766880
Backup ContactDr. Marwa Tolba, Assistant Professor
Mka05@fayoum.edu.eg01067789982

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026