Studies on Adsorption International Learning Initiative Global

NCT07123909 | Recruiting

• 1 other identifier: IEC-4/27012025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Program dialysis; Sorption; Complications of program dialysis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in serum IL-6, pg/ml

  By the third month

Secondary Outcomes (18)

• Change frome baseline in serum IL-1, pg/ml

  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 β2-microglobulin, mg/L

  Monthly for 3 months

Study Arms (2)

Combination of hemodialysis and hemosorption

EXPERIMENTAL

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.

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

Standard hemodialysis procedure

NO INTERVENTION

Dialysis patients on standard dialysis procedure

Interventions

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

Also known as: Jafron HA130, hemosorption, cartridge for hemosorption, Sorption, Program dialysis

Combination of hemodialysis and hemosorption

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current use of steroids or immunosuppressive therapy
• History of kidney transplantation
• Diagnosis of cancer
• Pregnancy

Sponsors & Collaborators

• Botkin Hospital: lead

Study Sites (1)

Botkin Hospital

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Uremia; Bronchiolitis Obliterans Syndrome; Toxemia

Interventions

Hemoperfusion; Sorption Detoxification

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Infections

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Central Study Contacts

Evgeny V Shutov, PhD

CONTACT

+79055251002; shutov_e_v@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Nephrology Center, Botkin Hospital

Model Details: 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

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: August 14, 2025
• Study Start: June 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)