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Clearance of molecules and inflammatory markers: high-flux vs medium cut-off dialyzers

Comparison of molecule clearance and pro-inflammatory markers between high-flux and medium cut-off dialyzers (ELISIO™ 21): a cross-over study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10242184
Enrollment
13
Registered
2024-12-16
Start date
2022-10-01
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage renal disease Urological and Genital Diseases

Interventions

A simple randomization method was used to select participants from the eligible candidates. Group allocation, determined by the dialyzer type, was also assigned through randomization based on each pat

Sponsors

Nipro (Japan)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Being on renal replacement therapy with hemodialysis for at least 3 months prior to inclusion

Exclusion criteria

Exclusion criteria: 1. Patients with treatment regimens of fewer than three sessions per week 2. Minors 3. Patients hospitalized or deceased during the study

Design outcomes

Primary

MeasureTime frame
Pre- and post-dialysis levels of creatinine (mg/dL), urea (mg/dL), phosphorus (mg/dL), parathyroid hormone (PTH, pg/mL), and albumin (g/dL) measured using blood sample analysis at the laboratory of Torrecárdenas University Hospital in blood samples collected during the second weekly session of each patient

Secondary

MeasureTime frame
Pre- and post-dialysis levels of beta-2 microglobulin (mg/L), myoglobin (ng/mL), C-reactive protein (CRP, mg/L), procalcitonin (ng/mL), and interleukin-6 (IL-6, pg/mL) measured using blood sample analysis at the laboratory of Torrecárdenas University Hospital in blood samples collected during the second weekly session of each patient

Countries

Spain

Contacts

Public ContactJavier Ramírez Santos
jrs519@inlumine.ual.es+34 (0)950 18 68 19

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026