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CKD (Chronic Kidney Disease) Stage 5DSAILINGNCT07123909

Studies on Adsorption International Learning Initiative Global

A study testing Patients will undergo a combined hemodialysis and hemosorption procedure. The study cartridge for hemosorption by Jafron HA130 contains the original adsorbing material. in people with CKD (Chronic Kidney Disease) Stage 5D and Uremia; Chronic, run by Botkin Hospital at 1 site in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Use of sorption technologies in patients undergoing maintenance hemodialysis with inflammatory syndrome and clinical manifestations of uremia Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Patients will undergo a combined hemodialysis and hemosorption procedure. The study cartridge for hemosorption by Jafron HA130 contains the original adsorbing material.
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteRussia
Study dates
1 Jun 2025to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Evgeny V Shutov, PhD contact

+79055251002

shutov_e_v@mail.ru

Russia1 site, 1 recruiting

  • Botkin Hospital

    Moscow

    Evgeny V Shutov, PhD, +79055251002, shutov_e_v@mail.ru

    Stepan A Bolshakov, +79162850296, my@stepan-bolshakov.ru

    Recruiting

Other trials in Russia

About this study

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

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

Read the detailed description

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.

Being tested
Patients will undergo a combined hemodialysis and hemosorption procedure. The study cartridge for hemosorption by Jafron HA130 contains the original adsorbing material.
Keywords
Program dialysis, Sorption, Complications of program dialysis
Medical subject headings
Renal Insufficiency, Chronic, Uremia, Bronchiolitis Obliterans Syndrome, Toxemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Jafron HA130, hemosorption, cartridge for hemosorption, Sorption

    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

Study groups in NCT07123909
Study groupRoleWhat they receive
Combination of hemodialysis and hemosorptionExperimentalDialysis patients will undergo a combined procedure of hemodialysis and hemosorption using the Jafron HA130 cartridge three times per week during the first month, twice per week in the second month, and once per week in the third month.
Receives: Device: Patients will undergo a combined hemodialysis and hemosorption procedure. The study cartridge for hemosorption by Jafron HA130 contains the original adsorbing material.
Standard hemodialysis procedureNo interventionDialysis patients on standard dialysis procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: By the third month

Secondary outcomes (18)

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

    Measured: Monthly for 3 months

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

    Measured: Monthly for 3 months

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

    Measured: Monthly for 3 months

  4. Change from baseline in CRP, mg/L

    Measured: Monthly for 3 months

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

    Measured: Monthly for 3 months

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

    Measured: Monthly for 3 months

  7. Change from baseline in PTH, pg/ml

    Measured: Monthly for 3 months

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

    Measured: Monthly for 3 months

  9. Change from baseline in ferritin, mcg/L

    Measured: Monthly for 3 months

  10. Change from baseline in saturated transferrin, TS%

    Measured: Monthly for 3 months

  11. Change from baseline in albumin, g/L

    Measured: Monthly for 3 months

  12. Change from baseline in phosphorus, mmol/L

    Measured: Monthly for 3 months

  13. Change from baseline in calcium, mmol/L

    Measured: Monthly for 3 months

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

    Measured: Monthly for 3 months

  15. Change from baseline in creatinine, mg/dL

    Measured: Monthly for 3 months

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

    Measured: Monthly for 3 months

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

    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.

    Measured: Monthly for 3 months

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

    From 0 to 10 where 10 is maximum

    Measured: Monthly for 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2025
  2. Study start1 Jun 2025
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study will comprise two groups of 30 participants each. The intervention group will receive standard hemodialysis with adjunctive hemosorption therapy using the Jafron HA130 cartridge, while the control group will receive standard hemodialysis treatment
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07123909
Sponsor's protocol ID
IEC-4/27012025
Acronym
SAILING
Status last verified
Dec 2025
First submitted
4 Jul 2025
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Patients will undergo a combined hemodialysis and hemosorption procedure. The study cartridge for hemosorption by Jafron HA130 contains the original adsorbing material. in people with CKD (Chronic Kidney Disease) Stage 5D and Uremia; Chronic, run by Botkin Hospital at 1 site in Russia.

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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Dec 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 Russia. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Evgeny V Shutov, PhD (+79055251002, shutov_e_v@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in serum IL-6, pg/ml (time frame: By the third month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07123909.

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 10 Dec 2025.

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