Chronic Kidney DiseaseNCT06877286
Low Sirtuin-1 Levels Are Linked to Erythropoietin Resistance in Hemodialysis Patients.
An observational study of Chronic Kidney Disease and Hemodialysis, run by Cuma Bulent Gul at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Hemodialysis, Anemia in End Stage Renal Disease
- What is being tested?
- Sirtuin-1 Level Measurement
- How many people
- 391 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 15 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Aged ≥18 years
- Receiving hemodialysis
- Availability of laboratory data to calculate ERI
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between EPO Resistance and Sirtuin-1 Levels in Hemodialysis Patients.
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.
Read the 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.
- Being tested
- Sirtuin-1 Level Measurement
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirtuin-1 Level MeasurementDiagnostic test
Measurement of serum Sirtuin-1 levels using ELISA in hemodialysis patients to evaluate the relationship between Sirtuin-1 levels and erythropoietin resistance
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis Patients | Patients with erythropoietin resistance undergoing hemodialysis. Receives: Diagnostic Test: Sirtuin-1 Level Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sirtuin-1 levels
Measurement of serum Sirtuin-1 levels using ELISA to evaluate its association with erythropoietin resistance.
Measured: Measured at baseline (initial blood sample)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Aug 2020
- Primary completion30 Mar 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cuma Bulent Gul
- Sponsor type
- University, hospital or other
- Collaborators
- Bursa Yuksek Ihtisas Training and Research Hospital
- Responsible party
- Sponsor-investigator, Cuma Bulent Gul, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877286
- Sponsor's protocol ID
- SIRT1-EPO-2020
- Other IDs
- 2011-KAEK-25 2020/07-06
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality and data privacy regulations.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between EPO Resistance and Sirtuin-1 Levels in Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT06877286
- Acronym / sponsor ID
- SIRT1-EPO-2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Cuma Bulent GulUniversity, hospital or other
- Collaborators
- Bursa Yuksek Ihtisas Training and Research Hospital
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis Patients | – | Diagnostic Test: Sirtuin-1 Level MeasurementPatients with erythropoietin resistance undergoing hemodialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Aged ≥18 years
- Receiving hemodialysis
- Availability of laboratory data to calculate ERI
Key exclusion criteria (8 listed)
- Autosomal polycystic kidney disease
- Malignancies
- Infectious diseases
- Chronic rheumatological disorders
- Vitamin B12 or folic acid deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sirtuin-1 Level MeasurementMeasurement of serum Sirtuin-1 levels using ELISA in hemodialysis patients to evaluate the relationship between Sirtuin-1 levels and erythropoietin resistance | Diagnostic test | Hemodialysis Patients |
Primary outcome
Sirtuin-1 levels
Time frame: Measured at baseline (initial blood sample)
Measurement of serum Sirtuin-1 levels using ELISA to evaluate its association with erythropoietin resistance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality and data privacy regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Hemodialysis, run by Cuma Bulent Gul at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sirtuin-1 levels (time frame: Measured at baseline (initial blood sample)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.