Studies on Adsorption International Learning Initiative Global

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBotkin Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Current use of steroids or immunosuppressive therapy

History of kidney transplantation

Diagnosis of cancer

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Combination of hemodialysis and hemosorptionExperimental treatment 1 intervention
Group B: Standard hemodialysis procedureNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
By the third month

Secondary outcomes

1

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

Time frame
Monthly for 3 months
2

Change from baseline in serum IL-8, pg/ml

Time frame
Monthly for 3 months
3

Change from baseline in serum IL-10, pg/ml

Time frame
Monthly for 3 months
4

Change from baseline in CRP, mg/L

Time frame
Monthly for 3 months

Other outcomes

Sponsors and contacts

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