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

NCT06877286 | Completed

• 2 other identifiers: SIRT1-EPO-20202011-KAEK-25 2020/07-06
• Study Type: observational
• Target: 391
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Sirtuin-1 levels

  Measurement of serum Sirtuin-1 levels using ELISA to evaluate its association with erythropoietin resistance.

  Measured at baseline (initial blood sample)

Study Arms (1)

Hemodialysis Patients

Patients with erythropoietin resistance undergoing hemodialysis.

Diagnostic Test: Sirtuin-1 Level Measurement

Interventions

Sirtuin-1 Level Measurement DIAGNOSTIC_TEST

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

Hemodialysis Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (≥18 years) undergoing hemodialysis in provincial hemodialysis clinics in Bursa, Turkey, between August 2020 and March 2021. Eligible patients had available laboratory data to calculate the Erythropoietin Resistance Index (ERI). Patients with certain comorbidities, such as malignancies, infectious diseases, chronic rheumatological disorders, and vitamin deficiencies, were excluded from the study.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cuma Bulent Gul: lead
• Bursa Yuksek Ihtisas Training and Research Hospital: collaborator

Study Sites (1)

Uludag University Medical School

Bursa, 16059, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples were retained at -80°C for SIRT1 analysis and subsequently discarded after analysis.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: August 1, 2020
• Primary Completion: March 30, 2021
• Study Completion: October 15, 2021
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)