The Use of Sorption Technologies in Patients Receiving Program Hemodialysis With Inflammatory Syndrome
Phase: NA
Conditions: CKD (Chronic Kidney Disease) Stage 5D, Uremia; Chronic, Uremic; Toxemia, Inflammation Chronic, Hemodialysis, Inflammation Biomarkers, Dialysis Related Complication, Anemia Associated With End Stage Renal Disease
Sponsor: Botkin Hospital

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S.A.I.L.I.N.G. 
Studies on Adsorption International Learning Initiative Global 
 
 
1) Research and Researcher’s Information 
 
Research Topic 
The use of sorption technologies in patients receiving program hemodialysis 
with inflammatory syndrome 
Key Words 
Program dialysis 
Sorption 
Complications of program 
dialysis 
Specialty 
Nephrology 
Blood Purification Therapy 
Principal 
Investigator 
Name 
Evgeny Shutov 
 
Title 
Head of the Nephrology 
Center, Botkin Hospital, PhD 
Institute 
Botkin Hospital, Moscow 
Email 
shutov_e_v@mail.ru 
Tel. 
+79858086519 
Address 
125284, Moscow, 2nd Botkinsky pr-d, 5 
Code 
 
 
Research Start and 
Completion Time 
 
September 2024 
August 2025 
 

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2) Research Abstract 
 
Research Topic 
Use of sorption technologies in patients undergoing maintenance 
hemodialysis with inflammatory syndrome and clinical manifestations of 
uremia 
Study Aim 
To evaluate the effect of hemosorption with the Jafron HA130 cartridge 
combined with hemodialysis on inflammatory markers and clinical symptoms 
of uremic intoxication 
Study Design 
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.The total study duration will be three 
months. 
Total Patient 
Number 
60 patients 
Selection of the 
Patients 
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. Elevated interleukin-6 (IL-6) and/or C-reactive protein (CRP) levels above 
reference values 
Exclusive Criteria: 
1. Current use of steroids or immunosuppressive therapy 
2. History of kidney transplantation 
3. Diagnosis of cancer 
4. Pregnancy 
Intervention Group 

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Treatment Plan 
Dialysis patients will undergo a combined procedure (hemodialysis and 
hemosorption) using the Jafron HA130 cartridge three times a week in the first 
month, twice a week in the next month, once a week in the third month. 
Control Group 
Patients on standard dialysis procedure (30 patients) 
Endpoints 
Primary Endpoints  
The effectiveness of combined procedures (hemodialysis + hemosorption) 
compared with standard hemodialysis in reducing the level of the IL-6 
Secondary Endpoints 
Change from baseline in serum Il-1, IL-8, IL-10, CRP, beta2-microglobulin, free 
light chains, PTH, serum iron, ferritin, TS, phosphorus, calcium, BUN, creatinine, 
Hb. 
Change from baseline in Hospital Anxiety and Depression Scale Score 
Change from baseline in pruritus (Visual Analogue Scale) 
Safety Index 
Assess safety based on the number of serious adverse events and adverse 
events 
Statistics Method The assessment will be carried out using standard statistical methods 
Expected Results Reduced levels of inflammatory markers, middle molecules and associated 
uremic manifestations 
The Importance 
of Study 
Improved treatment results 
Study Duration 
1 year