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Use of sorption technologies in patients undergoing maintenance hemodialysis with inflammatory syndrome and clinical manifestations of uremia
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard hemodialysis procedure | No Intervention | Dialysis patients on standard dialysis procedure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in serum IL-6, pg/ml | By the third month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evgeny V Shutov, PhD | Contact | +79055251002 | shutov_e_v@mail.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Botkin Hospital | Recruiting | Moscow | Russia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 16, 2025 | Aug 12, 2025 |
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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
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|
|
| 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 |
| 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 serum iron, mcg/dL | Monthly for 3 months |
| Change from baseline in ferritin, mcg/L | Monthly for 3 months |
| Change from baseline in saturated transferrin, TS% | 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 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 hemoglobin (Hb), g/L | Monthly for 3 months |
| Change from baseline in Hospital Anxiety and Depression Scale Score | 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. | Monthly for 3 months |
| Change from baseline in pruritus (Visual Analogue Scale) | From 0 to 10 where 10 is maximum | Monthly for 3 months |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D014511 | Uremia |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D014115 | Toxemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006464 | Hemoperfusion |
| D016060 | Sorption Detoxification |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
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