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Effects of Extracorporeal Blood Flow Rates on Patient Tolerance for LIXELLE® Treatment during Outpatient Hemodialysis.
Dhande, Onkar S; Teichert, Arnaud; Broumand, Varshasb; Kakita, Haruki; Kitamura, Ayaka; Fukunishi, Masaaki; Argyropoulos, Christos P; Czirr, Eva; Nelson, Peter J.
Afiliación
  • Dhande OS; Alkahest, Inc., A Grifols Company, San Carlos, California, USA.
  • Teichert A; Alkahest, Inc., A Grifols Company, San Carlos, California, USA.
  • Broumand V; South Texas Renal Care Group, San Antonio, Texas, USA.
  • Kakita H; Kaneka Medix Corporation, Osaka, Japan.
  • Kitamura A; Kaneka Medix Corporation, Osaka, Japan.
  • Fukunishi M; Kaneka Medix Corporation, Osaka, Japan.
  • Argyropoulos CP; Division of Nephrology, Department of Medicine, University of New Mexico, Albuquerque, New Mexico, USA.
  • Czirr E; Alkahest, Inc., A Grifols Company, San Carlos, California, USA.
  • Nelson PJ; Alkahest, Inc., A Grifols Company, San Carlos, California, USA.
Blood Purif ; 53(4): 306-315, 2024.
Article en En | MEDLINE | ID: mdl-38228100
ABSTRACT

INTRODUCTION:

Accumulation of ß2-microglobulin (B2M) in dialysis patients contributes to several comorbidities of end-stage kidney disease (ESKD). The LIXELLE® device adsorbs B2M from blood using sorbent bead technology. Studies in Japan showed that LIXELLE treatment during hemodialysis (HD) at blood flow rates up to 250 mL/min removes B2M above HD alone and is well tolerated. We investigated tolerance for LIXELLE treatment during HD at higher HD blood flow rates standard in the USA.

METHODS:

A prospective, open-label, non-randomized, single-arm, early-feasibility study (EFS) assessed tolerance and safety of LIXELLE treatment during HD at blood flow rates up to 450 mL/min. ESKD patients (40-75 years old) on thrice weekly outpatient HD were eligible. After a 1-week HD run-in, patients received LIXELLE plus HD at a blood flow rate of 250 mL/min (1 week), followed by LIXELLE plus HD at a blood flow rate up to 450 mL/min (1 week). These blood flow rates were tested with three LIXELLE column sizes in sequence (treatment = 6 weeks). B2M removal was assessed for each combination.

RESULTS:

Ten patients with a historic intradialytic hypotension (IDH) rate of 0.42 events/HD session/patient were enrolled. Nine patients completed all combinations without IDH events (treatment IDH rate 0.56 events/HD session/patient). No treatment-emergent serious adverse events or significant changes in red blood cell, platelet, or complement indices except haptoglobin were reported. B2M reduction ratios and removal of select proteins (<40 kDa) increased with escalating column size and blood flow rate.

CONCLUSION:

LIXELLE plus HD across all column sizes was safe and well tolerated at blood flow rates up to 450 mL/min. Extent of B2M removal corresponded to column size-blood flow rate combinations. This EFS provides a risk profile to guide further studies of LIXELLE in ESKD patients at US-standard blood flow rates.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diálisis Renal / Fallo Renal Crónico Tipo de estudio: Clinical_trials Límite: Adult / Aged / Humans / Middle aged Idioma: En Revista: Blood Purif Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Suiza
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diálisis Renal / Fallo Renal Crónico Tipo de estudio: Clinical_trials Límite: Adult / Aged / Humans / Middle aged Idioma: En Revista: Blood Purif Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Suiza