Hemoadsorption with the Jafron HA130 cartridge during hemodialysis for adults on maintenance dialysis with inflammation
The Use of Sorption Technologies in Patients Receiving Program Hemodialysis With Inflammatory Syndrome
This trial will try adding Jafron HA130 hemoadsorption to regular hemodialysis to see if it reduces inflammation in adults on maintenance dialysis who have high CRP or IL-6.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Botkin Hospital Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT07123909 on ClinicalTrials.gov |
What this trial studies
Thirty adults on maintenance hemodialysis with elevated CRP and/or IL-6 will receive hemoadsorption with a Jafron HA130 cartridge performed concurrently with their dialysis sessions. The intervention is scheduled three times per week in month 1, twice per week in month 2, and once per week in month 3. Inflammatory markers (CRP, IL-1, IL-6, IL-8, β2-microglobulin, free light chains), PTH, standard biochemistry, and complete blood counts will be measured at baseline and monthly. The single-center study is conducted at Botkin Hospital in Moscow and excludes patients on steroids, with prior transplant, cancer, pregnancy, or active infection.
Who should consider this trial
Good fit: Adults (≥18) on standard thrice-weekly hemodialysis with KT/V ≥ 1.4 and elevated CRP or IL-6, without active infection, immunosuppression, cancer, pregnancy, or prior kidney transplant.
Not a fit: Patients without elevated inflammatory markers, those with active infections, on steroids or other immunosuppressants, with cancer, prior transplant, or who are pregnant are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, hemoadsorption could lower chronic inflammation and related complications in maintenance hemodialysis patients.
How similar studies have performed: Similar sorbent hemoadsorption devices have reduced circulating cytokine levels in small studies, but durable clinical benefits in chronic dialysis populations remain unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Exclusion Criteria: 1. Current use of steroids or immunosuppressive therapy 2. History of kidney transplantation 3. Diagnosis of cancer 4. Pregnancy
Where this trial is running
Moscow
- Botkin Hospital — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Evgeny V Shutov, PhD
- Email: shutov_e_v@mail.ru
- Phone: +79055251002
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.