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NCT Number: NCT07123909

Studies on Adsorption International Learning Initiative Global

Use of sorption technologies in patients undergoing maintenance hemodialysis with inflammatory syndrome and clinical manifestations of uremia

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Key information

Conditions

CKD (Chronic Kidney Disease) Stage 5D Anemia Associated With End Stage Renal Disease Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Disease Dialysis Related Complication Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Graft vs Host Disease Hemodialysis Immune System Diseases Infections Inflammation Biomarkers Inflammation Chronic Kidney Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Toxemia Uremia Uremia; Chronic Uremic; Toxemia Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Botkin Hospital

Moscow, Russia

Location status: Recruiting

Location contact

Dmitry V Fedorov

SUB_INVESTIGATOR

Evgeny V Shutov, PhD

CONTACT

[email protected]

+79055251002

Galina V Kotlyarova

SUB_INVESTIGATOR

Stepan A Bolshakov

CONTACT

[email protected]

+79162850296

Stepan A Bolshakov

SUB_INVESTIGATOR

About this study

This study will involve 30 hemodialysis patients selected based on examination results showing elevated C-reactive protein (CRP) and/or interleukin-6 (IL-6) levels. Participants will undergo hemoadsorption with the Jafron HA130 cartridge performed concurrently with hemodialysis: three times per week during the first month, twice per week during the second month, and once per week during the third month.

The following parameters will be assessed: inflammatory markers (CRP, IL-1, IL-6, IL-8, β2-microglobulin, free light chains of immunoglobulins), parathyroid hormone (PTH), standard biochemical blood tests (creatinine, urea, calcium, phosphorus, albumin, iron metabolism), and complete blood count. Analyses will be performed at baseline (before inclusion) and monthly thereafter.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adequate dialysis defined by a KT/V index ≥ 1.4
  • No active inflammatory process or infection
  • Age ≥ 18 years
  • Receiving standard hemodialysis regimen three times weekly, at least 4 hours per session
  • Participants with elevated interleukin-6 (IL-6) and/or C-reactive protein (CRP) levels exceeding local laboratory reference values

Exclusion criteria

  • Current use of steroids or immunosuppressive therapy
  • History of kidney transplantation
  • Diagnosis of cancer
  • Pregnancy

Treatment and study plan

Patients will undergo a combined hemodialysis and hemosorption procedure. The study cartridge for hemosorption by Jafron HA130 contains the original adsorbing material.

Device

The test cartridge will be used in addition to the ongoing program hemodialysis three times a week in the first month, twice a week in the next month, once a week in the third month

Other names: Jafron HA130, hemosorption, cartridge for hemosorption, Sorption, Program dialysis

Primary outcomes

  1. Change from baseline in serum IL-6, pg/ml

    Time frame: By the third month

Secondary outcomes

  1. Change frome baseline in serum IL-1, pg/ml

    Time frame: Monthly for 3 months

  2. Change from baseline in serum IL-8, pg/ml

    Time frame: Monthly for 3 months

  3. Change from baseline in serum IL-10, pg/ml

    Time frame: Monthly for 3 months

  4. Change from baseline in CRP, mg/L

    Time frame: Monthly for 3 months

  5. Change from baseline in β2-microglobulin, mg/L

    Time frame: Monthly for 3 months

  6. Change from baseline in free light chains, mcg/ml

    Time frame: Monthly for 3 months

  7. Change from baseline in PTH, pg/ml

    Time frame: Monthly for 3 months

  8. Change from baseline in serum iron, mcg/dL

    Time frame: Monthly for 3 months

  9. Change from baseline in ferritin, mcg/L

    Time frame: Monthly for 3 months

  10. Change from baseline in saturated transferrin, TS%

    Time frame: Monthly for 3 months

  11. Change from baseline in albumin, g/L

    Time frame: Monthly for 3 months

  12. Change from baseline in phosphorus, mmol/L

    Time frame: Monthly for 3 months

  13. Change from baseline in calcium, mmol/L

    Time frame: Monthly for 3 months

  14. Change from baseline in blood urea nitrogen (BUN), mmol/L

    Time frame: Monthly for 3 months

  15. Change from baseline in creatinine, mg/dL

    Time frame: Monthly for 3 months

  16. Change from baseline in hemoglobin (Hb), g/L

    Time frame: Monthly for 3 months

  17. Change from baseline in Hospital Anxiety and Depression Scale Score

    Time frame: Monthly for 3 months

    Scale consists of two subscales. The minimum score of each is 0, and the maximum score on each of the two subscales is 21. The higher the score, the higher the level of anxiety and depression.

  18. Change from baseline in pruritus (Visual Analogue Scale)

    Time frame: Monthly for 3 months

    From 0 to 10 where 10 is maximum

Study contacts

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

Evgeny V Shutov, PhD

CONTACT

[email protected]

+79055251002

Sponsors and collaborators

Lead sponsor

Botkin Hospital

Other

Registry information

Official study title

The Use of Sorption Technologies in Patients Receiving Program Hemodialysis With Inflammatory Syndrome

Acronym: SAILING

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2025
Registry last updated
Dec 10, 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.

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