NCT06877286

Low Sirtuin-1 Levels Are Linked to Erythropoietin Resistance in Hemodialysis Patients.

The Relationship Between EPO Resistance and Sirtuin-1 Levels in Hemodialysis Patients.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 391 (actual)
• Sponsor: Cuma Bulent Gul · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the relationship between Sirtuin-1 (SIRT1) levels and erythropoietin resistance in hemodialysis patients. The study aims to determine whether low SIRT1 levels contribute to EPO resistance and to explore the potential mechanisms involved. Blood samples and clinical data from hemodialysis patients will be analyzed to evaluate this relationship.

Detailed description

This study explores the association between Sirtuin-1 (SIRT1) levels and erythropoietin resistance in hemodialysis patients. Erythropoiesis-stimulating agents (ESAs) are commonly used to treat anemia in chronic kidney disease (CKD) patients undergoing hemodialysis. However, a significant proportion of patients exhibit hyporesponsiveness to ESAs, leading to suboptimal anemia management. SIRT1, a nicotinamide adenine dinucleotide (NAD+)-dependent histone deacetylase, regulates hypoxia and iron metabolism by modulating the activity of hypoxia-inducible factor 1α (HIF-1α). Lower SIRT1 levels may impair HIF-1α activity and contribute to reduced erythropoietin (EPO) responsiveness. In this multicentric cross-sectional cohort study, 391 adult hemodialysis patients from provincial dialysis clinics in Bursa, Turkey, were enrolled between August 2020 and March 2021. ESA responsiveness was assessed using the Erythropoietin Resistance Index (ERI), calculated as the weekly weight-adjusted ESA dose divided by hemoglobin concentration. Serum SIRT1 levels were measured using a human SIRT1 ELISA kit. The study aims to determine whether low SIRT1 levels are independently associated with higher ERI scores and to identify other clinical and biochemical parameters influencing ESA responsiveness. Multiple regression and correlation analyses will be performed to evaluate the relationship between SIRT1 levels, ERI scores, ferritin levels, and other clinical factors. Logistic regression will also be conducted to explore whether SIRT1 is an independent predictor of high ERI scores (≥50th percentile). The findings from this study may provide new insights into the molecular mechanisms underlying ESA resistance and highlight the potential role of SIRT1 as a target for improving anemia management in hemodialysis patients.

Conditions

• Chronic Kidney Disease
• Hemodialysis
• Anemia in End Stage Renal Disease
• Erythropoietin

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Sirtuin-1 Level Measurement	Measurement of serum Sirtuin-1 levels using ELISA in hemodialysis patients to evaluate the relationship between Sirtuin-1 levels and erythropoietin resistance

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-03-30
• Completion: 2021-10-15
• First posted: 2025-03-14
• Last updated: 2025-03-19

Locations

1 site across 1 country: Turkey (Türkiye)