Studies on Adsorption International Learning Initiative Global

Botkin Hospital60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

CKD (Chronic Kidney Disease) Stage 5D Uremia; Chronic Uremic; Toxemia

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: By the third month