An interventional study of Patients will undergo a combined hemodialysis and hemosorption procedure. The study cartridge for hemosorption by Jafron HA130 contains the original adsorbing material. in CKD (Chronic Kidney Disease) Stage 5D, Uremia; Chronic and Uremic; Toxemia, sponsored by Botkin Hospital. Recruiting at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Botkin Hospital · Not applicable, Interventional, and Treatment
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.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's planned enrollment of 60 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Botkin Hospital is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dialysis patients on standard dialysis procedure
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
Change from baseline in serum IL-6, pg/ml
Time frame: By the third month
Change frome baseline in serum IL-1, pg/ml
Time frame: Monthly for 3 months
Change from baseline in serum IL-8, pg/ml
Time frame: Monthly for 3 months
Change from baseline in serum IL-10, pg/ml
Time frame: Monthly for 3 months
Change from baseline in CRP, mg/L
Time frame: Monthly for 3 months
Change from baseline in β2-microglobulin, mg/L
Time frame: Monthly for 3 months
Change from baseline in free light chains, mcg/ml
Time frame: Monthly for 3 months
Change from baseline in PTH, pg/ml
Time frame: Monthly for 3 months
Change from baseline in serum iron, mcg/dL
Time frame: Monthly for 3 months
Change from baseline in ferritin, mcg/L
Time frame: Monthly for 3 months
Change from baseline in saturated transferrin, TS%
Time frame: Monthly for 3 months
Change from baseline in albumin, g/L
Time frame: Monthly for 3 months
Change from baseline in phosphorus, mmol/L
Time frame: Monthly for 3 months
Change from baseline in calcium, mmol/L
Time frame: Monthly for 3 months
Change from baseline in blood urea nitrogen (BUN), mmol/L
Time frame: Monthly for 3 months
Change from baseline in creatinine, mg/dL
Time frame: Monthly for 3 months
Change from baseline in hemoglobin (Hb), g/L
Time frame: 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.
Time frame: Monthly for 3 months
Change from baseline in pruritus (Visual Analogue Scale)
From 0 to 10 where 10 is maximum
Time frame: Monthly for 3 months
Plan to share: No
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