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

NCT ID: NCT06877286

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

391 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-10-15

Brief Summary

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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

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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

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Chronic Kidney Disease Hemodialysis Anemia in End Stage Renal Disease Erythropoietin

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Hemodialysis Patients

Patients with erythropoietin resistance undergoing hemodialysis.

Sirtuin-1 Level Measurement

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Aged ≥18 years
* Receiving hemodialysis
* Availability of laboratory data to calculate ERI

Exclusion Criteria

* Autosomal polycystic kidney disease
* Malignancies
* Infectious diseases
* Chronic rheumatological disorders
* Vitamin B12 or folic acid deficiency
* CRP levels ≥ 5 mg/L
* PTH levels ≥ 300 pg/dL
* Inadequate hemodialysis (Kt/Vurea \< 1.2)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Cuma Bulent Gul

OTHER

Sponsor Role lead

Responsible Party

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Cuma Bulent Gul

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Uludag University Medical School

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2011-KAEK-25 2020/07-06

Identifier Type: OTHER

Identifier Source: secondary_id

SIRT1-EPO-2020

Identifier Type: -

Identifier Source: org_study_id

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