Studies on Adsorption International Learning Initiative Global

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will comprise two groups of 30 participants each. The intervention group will receive standard hemodialysis with adjunctive hemosorption therapy using the Jafron HA130 cartridge, while the control group will receive standard hemodialysis treatment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combination of hemodialysis and hemosorption

Dialysis patients will undergo a combined procedure of hemodialysis and hemosorption using the Jafron HA130 cartridge three times per week during the first month, twice per week in the second month, and once per week in the third month.

Group Type EXPERIMENTAL

Patients will undergo a combined hemodialysis and hemosorption procedure. The study cartridge for hemosorption by Jafron HA130 contains the original adsorbing material.

Intervention Type 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

Standard hemodialysis procedure

Dialysis patients on standard dialysis procedure

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Jafron HA130 hemosorption cartridge for hemosorption Sorption Program dialysis

Eligibility Criteria

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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