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NCT Number: NCT06983756

" 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 "

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erythropoietin

Drug

EPO resistance

Primary outcomes

  1. HB

    Time frame: 6 month

    Hemoglobin in blood

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Marwa Tolba, Assistant Professor

CONTACT

[email protected]

01067789982

Nada Elsayed, Bachelor

CONTACT

[email protected]

01000766880

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.