Clinical trial · Interventional
REmoval of Free Light Chains. A COmpaRison of Three Different dialyzERs
REmoval of Free Light Chains in Hemodialysis Patients Without Multiple Myeloma. A Crossover COmpaRison of Three Different dialyzERs
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Immunoglobulin light chains are classified as middle molecule uremic toxins able to interact with B lymphocyte membranes leading to the activation of transmembrane signaling. The ensuing impairment of neutrophil function can contribute to the chronic inflammation state of uremic patients, and the increased risk of bacterial infections or vascular calcifications. The aim of this crossover observational study was to assess the difference in free light chain removal by three different hemodialysis filters in patients not affected by multiple myeloma. Free light chain removal was compared in the polymethylmethacrylate (PMMA) membrane Filtryzer BK-F, the polyphenylene HFR17 filter and the conventional polysulfone filter F7 High Performance dialysers (HPS). Twenty chronic hemodialysis patients were enrolled. The patients were randomized into two groups of treatment lasting six weeks each. The dialysis sessions checked were the midweek sessions and the blood was drawn at times 0, 120' and 240'. Kappa (k) and lambda (l) light chain levels, beta2microglobulin (β2M), C reactive protein (CRP) and albumin were checked.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Complication of Hemodialysis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| F7 filter | Device | — | UNRESOLVED |
| HFR17 filter | Device | — | UNRESOLVED |
| PMMA filter | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Six bicarbonate dialysis session with PMMA dialysis filter for 2 weeks, followed by 2 weeks of 6 on-line HFR session with HFR17 dialysis filter, than 6 bicarbonate dialysis session for 2 weeks with F7 dialysis filter.
- interventionNames
- Device: PMMA filter
- Device: HFR17 filter
- Device: F7 filter
- type
- EXPERIMENTAL
- label
- Group B
- description
- Six on-line HFR session with HFR17 dialysis filter for 2 weeks, followed by 2 weeks of 6 o bicarbonate dialysis session with PMMA dialysis filter for 2 weeks, than 6 bicarbonate dialysis session for 2 weeks with F7 dialysis filter.
- interventionNames
- Device: PMMA filter
- Device: HFR17 filter
- Device: F7 filter
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * chronic hemodialysis patients * free light chain values \>100 mg/L for k chains or \>50 mg/L for lambda chains. * absence or \<200 ml/die residual diuresis * fistula or central venous catheter with blood flow \>250 ml/min. Exclusion Criteria: * intradialytic hypotension * multiple myeloma * poly-allergy * HIV positivity
References
Publications (23)
- BACKGROUNDVanholder R, De Smet R, Glorieux G, Argiles A, Baurmeister U, Brunet P, Clark W, Cohen G, De Deyn PP, Deppisch R, Descamps-Latscha B, Henle T, Jorres A, Lemke HD, Massy ZA, Passlick-Deetjen J, Rodriguez M, Stegmayr B, Stenvinkel P, Tetta C, Wanner C, Zidek W; European Uremic Toxin Work Group (EUTox). Review on uremic toxins: classification, concentration, and interindividual variability. Kidney Int. 2003 May;63(5):1934-43. doi: 10.1046/j.1523-1755.2003.00924.x. PMID 12675874
- BACKGROUNDCohen G. Immunoglobulin light chains in uremia. Kidney Int Suppl. 2003 May;(84):S15-8. doi: 10.1046/j.1523-1755.63.s84.8.x. PMID 12694299
- BACKGROUNDDesjardins L, Liabeuf S, Lenglet A, Lemke HD, Vanholder R, Choukroun G, Massy ZA; European Uremic Toxin (EUTox) Work Group. Association between free light chain levels, and disease progression and mortality in chronic kidney disease. Toxins (Basel). 2013 Nov 8;5(11):2058-73. doi: 10.3390/toxins5112058. PMID 24217396
- BACKGROUNDHaynes R, Hutchison CA, Emberson J, Dasgupta T, Wheeler DC, Townend JN, Landray MJ, Cockwell P. Serum free light chains and the risk of ESRD and death in CKD. Clin J Am Soc Nephrol. 2011 Dec;6(12):2829-37. doi: 10.2215/CJN.03350411. Epub 2011 Oct 27. PMID 22034503
- BACKGROUNDAoike I. Clinical significance of protein adsorbable membranes--long-term clinical effects and analysis using a proteomic technique. Nephrol Dial Transplant. 2007 Jul;22 Suppl 5:v13-9. doi: 10.1093/ndt/gfm295. PMID 17586841
- BACKGROUNDHutchison CA, Blade J, Cockwell P, Cook M, Drayson M, Fermand JP, Kastritis E, Kyle R, Leung N, Pasquali S, Winearls C; International Kidney and Monoclonal Gammopathy Research Group. Novel approaches for reducing free light chains in patients with myeloma kidney. Nat Rev Nephrol. 2012 Feb 21;8(4):234-43. doi: 10.1038/nrneph.2012.14. PMID 22349488
- Testa A, Dejoie T, Lecarrer D, Wratten M, Sereni L, Renaux JL. Reduction of free immunoglobulin light chains using adsorption properties of hemodiafiltration with endogenous reinfusion. Blood Purif. 2010;30(1):34-6. doi: 10.1159/000316684. Epub 2010 Jun 24.