Studies on Adsorption International Learning Initiative Global
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients will undergo a combined hemodialysis and hemosorption procedure. The study cartridge for hemosorption by Jafron HA130 contains the original adsorbing material..
- Who it may be relevant to
- Registry conditions: CKD (Chronic Kidney Disease) Stage 5D, Uremia; Chronic, Uremic; Toxemia, Inflammation Chronic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Use of Sorption Technologies in Patients Receiving Program Hemodialysis With Inflammatory Syndrome
Overview
Use of sorption technologies in patients undergoing maintenance hemodialysis with inflammatory syndrome and clinical manifestations of uremia
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.
Interventions
- Device Patients will undergo a combined hemodialysis and hemosorption procedure. The study cartridge for hemosorption by Jafron HA130 contains the original adsorbing material.
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
Primary outcome measures
- Change from baseline in serum IL-6, pg/ml [Time frame: By the third month]
Secondary outcome measures (12)
- Change frome baseline in serum IL-1, pg/ml [Time frame: Monthly for 3 months]
- Change from baseline in serum IL-8, pg/ml [Time frame: Monthly for 3 months]
- Change from baseline in serum IL-10, pg/ml [Time frame: Monthly for 3 months]
- Change from baseline in CRP, mg/L [Time frame: Monthly for 3 months]
- Change from baseline in β2-microglobulin, mg/L [Time frame: Monthly for 3 months]
- Change from baseline in free light chains, mcg/ml [Time frame: Monthly for 3 months]
- Change from baseline in PTH, pg/ml [Time frame: Monthly for 3 months]
- Change from baseline in serum iron, mcg/dL [Time frame: Monthly for 3 months]
- Change from baseline in ferritin, mcg/L [Time frame: Monthly for 3 months]
- Change from baseline in saturated transferrin, TS% [Time frame: Monthly for 3 months]
- Change from baseline in albumin, g/L [Time frame: Monthly for 3 months]
- Change from baseline in phosphorus, mmol/L [Time frame: Monthly for 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- Botkin Hospital — Moscow
Identifiers
NCT: NCT07123909 · IEC-4/27012025