Studies on Adsorption International Learning Initiative Global (SAILING)

Botkin Hospital

Status: Enrolling

Conditions: Inflammation Chronic; CKD (Chronic Kidney Disease) Stage 5D; Dialysis Related Complication; Inflammation Biomarkers; Hemodialysis; Uremia; Chronic; Anemia Associated With End Stage Renal Disease; Uremic; Toxemia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07123909

IEC-4/27012025

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Current use of steroids or immunosuppressive therapy
2. History of kidney transplantation
3. Diagnosis of cancer
4. Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Combination of hemodialysis and hemosorption

Experimental group

Description:

Dialysis 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.

Treatment:

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 procedure

No Intervention group

Description:

Dialysis patients on standard dialysis procedure