Studies on Adsorption International Learning Initiative Global

Not Applicable

Recruiting

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

• Registration Number: NCT07123909
• Lead Sponsor: Botkin Hospital

Brief Summary

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.

Study Timeline

• Study Start: 2025-06-01
• Study First Submitted: 2025-07-04
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Primary Completion: 2026-03-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in serum IL-6, pg/ml	By the third month

Secondary Outcome Measures

Name	Time	Method
Change frome baseline in serum IL-1, pg/ml	Monthly for 3 months
Change from baseline in ferritin, mcg/L	Monthly for 3 months
Change from baseline in serum IL-8, pg/ml	Monthly for 3 months
Change from baseline in serum IL-10, pg/ml	Monthly for 3 months
Change from baseline in CRP, mg/L	Monthly for 3 months
Change from baseline in free light chains, mcg/ml	Monthly for 3 months
Change from baseline in PTH, pg/ml	Monthly for 3 months
Change from baseline in saturated transferrin, TS%	Monthly for 3 months
Change from baseline in blood urea nitrogen (BUN), mmol/L	Monthly for 3 months
Change from baseline in creatinine, mg/dL	Monthly for 3 months
Change from baseline in pruritus (Visual Analogue Scale)	Monthly for 3 months	From 0 to 10 where 10 is maximum
Change from baseline in β2-microglobulin, mg/L	Monthly for 3 months
Change from baseline in serum iron, mcg/dL	Monthly for 3 months
Change from baseline in albumin, g/L	Monthly for 3 months
Change from baseline in phosphorus, mmol/L	Monthly for 3 months
Change from baseline in calcium, mmol/L	Monthly for 3 months
Change from baseline in hemoglobin (Hb), g/L	Monthly for 3 months
Change from baseline in Hospital Anxiety and Depression Scale Score	Monthly for 3 months	Scale consists of two subscales. The minimum score of each is 0, and the maximum score on each of the two subscales is 21. The higher the score, the higher the level of anxiety and depression.

Trial Locations

Locations (1)

Botkin Hospital; 🇷🇺 Moscow, Russian Federation