Actively Recruiting
The Use of Sorption Technologies in Patients Receiving Program Hemodialysis With Inflammatory Syndrome
Led by Botkin Hospital · Updated on 2025-12-10
60
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of sorption technologies in patients undergoing maintenance hemodialysis who have inflammatory syndrome and symptoms of uremia. This study involves 30 hemodialysis patients selected based on elevated levels of C-reactive protein (CRP) and/or interleukin-6 (IL-6). The purpose is to assess changes in inflammatory markers and other blood parameters over a three-month period while undergoing this treatment. Participants will receive hemoadsorption using the Jafron HA130 cartridge alongside their regular hemodialysis sessions. The combined hemodialysis and hemoadsorption will be performed three times weekly during the first month, twice weekly in the second month, and once weekly in the third month. Another group will continue with the standard hemodialysis procedure for comparison. Throughout the study, blood tests will measure inflammatory markers such as CRP, IL-1, IL-6, IL-8, and others, along with parathyroid hormone and standard biochemical tests. These assessments will be done before starting and monthly for three months. Researchers will monitor changes in these markers, as well as quality-of-life measures like anxiety, depression, and pruritus. The primary outcome is the change in IL-6 levels by the third month, with ongoing safety and efficacy monitoring during this time.
CONDITIONS
Brief Title
Studies on Adsorption International Learning Initiative Global
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adequate dialysis defined by a KT/V index 21 1.4
- No active inflammatory process or infection
- Age 18 years or older
- Receiving standard hemodialysis regimen three times weekly, at least 4 hours per session
- Elevated interleukin-6 (IL-6) and/or C-reactive protein (CRP) levels exceeding local laboratory reference values
You will not qualify if you...
- Current use of steroids or immunosuppressive therapy
- History of kidney transplantation
- Diagnosis of cancer
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 months
Participants receive combined hemodialysis and hemoadsorption using the Jafron HA130 cartridge according to the schedule.
Three times per week during the first month, twice per week during the second month, and once per week during the third month
Trial Site Locations
Total: 1 location
1
Botkin Hospital
Moscow, Russia
Actively Recruiting
Research Team
E
Evgeny V Shutov, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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