Abstract:Background: High-flux dialyzers shall effectively remove uremic toxins and be hemocompatible to minimize intradialytic humoral and cellular stimulation and long-term impact on patient outcomes. A new dialyzer with a modified membrane surface has been tested for performance and hemocompatibility. Methods: This multicenter, prospective, randomized, cross-over study applied for one week each the new polysulfone-based FX CorAL 600 (Fresenius Medical Care, Bad Homburg, Germany), the polyarylethersulfone-based Polyf… Show more
“…The β2-m RRs in the comPERFORM study were somewhat higher (range 72.7–75.5%) than in an earlier study comparing FX CorAL 600 with Polyflux 170H and SUREFLUX-17UX (70.3% and 67.7% for the two dialyzers with synthetic membranes; 51.3% for the cellulose-based dialyzer) [ 13 ]. This difference is explained by different treatment modalities and confirms observations of other authors that higher RRs can be obtained with higher substitution and blood flow rates [ 16 , 21 , 22 ].…”
Section: Discussionmentioning
confidence: 64%
“…This difference is explained by different treatment modalities and confirms observations of other authors that higher RRs can be obtained with higher substitution and blood flow rates [ 16 , 21 , 22 ]. In the study reported by Ehlerding et al [ 13 ], substitution flow rates were set manually to around 70 mL/min, whereas in comPERFORM they were automatically set by the dialysis machines and reached a mean of 92 mL/min. In addition, blood flow was slightly higher in the comPERFORM study (∼325 mL/min versus 305 mL/min).…”
Section: Discussionmentioning
confidence: 99%
“…For the primary variable β2-m RR, the non-inferiority margin of −2% and the standard deviation were taken from earlier studies with FX CorAL 600 dialyzer and the number of patients needed for this cross-over study was estimated accordingly [ 13 , 14 ]. A total of independent patients were required, fixing the error level at α = 2.5% for a one-sided test and aiming at a power of 1 − β = 80%.…”
Section: Methodsmentioning
confidence: 99%
“…Two earlier clinical trials evaluated the safety and performance of FX CorAL [ 13 ]. The first compared FX CorAL with two other dialyzers of the FX series (FMC) while the second compared FX CorAL to SUREFLUX by Nipro and Polyflux by Baxter/Gambro (Deerfield, IL, USA).…”
Section: Introductionmentioning
confidence: 99%
“…Moreover, haemocompatibility analyses showed significantly lower C5a and sC5b-9 complement activation for FX CorAL than for two comparators from the FX series. Compared with Polyflux and SUREFLUX, FX CorAL activated complement sC5b-9 significantly less [ 13 ].…”
Background
Dialyzers shall be designed to efficiently eliminate uremic toxins during a dialysis treatment, given that the accumulation of small and middle molecular weight uremic solutes is associated with increased mortality risk of patients with end-stage renal disease. In the present study we investigated the novel FX CorAL dialyzer with a modified membrane surface for the performance during online-hemodiafiltration in a clinical setting.
Methods
comPERFORM was a prospective, open, controlled, multi-centric, interventional, cross-over study with randomized treatment sequences. It randomized stable patients receiving regular post-dilution online hemodiafiltration (HDF) to FX CorAL 600 (Fresenius Medical Care Deutschland GmbH), xevonta Hi 15 (B. Braun), and ELISIO 150H (Nipro), each for one week. The primary outcome was β2-microglobulin removal rate (ß2-m RR) during online-HDF. Secondary endpoints were RR and/or clearance of ß2-m and other molecules. Albumin removal over time was an exploratory endpoint. Non-inferiority and superiority of FX CorAL 600 vs. competitors were tested.
Results
52 patients were included and analyzed. FX CorAL 600 showed the highest ß2-m RR (75.47%), followed by xevonta Hi 15 (74.01%) and ELISIO 150H (72.70%). Superiority to its competitors was statistically significant (P = 0.0216 and P < 0.0001, respectively). Secondary endpoints related to middle molecules affirmed these results. FX CorAL 600 demonstrated the lowest albumin removal up to 60 min, and its sieving properties changed less over time than with competitors.
Conclusions
FX CorAL 600 efficiently removed middle and small molecules and was superior to the two comparators in ß2-m RR. Albumin sieving kinetics point to a reduced formation of a secondary membrane.
“…The β2-m RRs in the comPERFORM study were somewhat higher (range 72.7–75.5%) than in an earlier study comparing FX CorAL 600 with Polyflux 170H and SUREFLUX-17UX (70.3% and 67.7% for the two dialyzers with synthetic membranes; 51.3% for the cellulose-based dialyzer) [ 13 ]. This difference is explained by different treatment modalities and confirms observations of other authors that higher RRs can be obtained with higher substitution and blood flow rates [ 16 , 21 , 22 ].…”
Section: Discussionmentioning
confidence: 64%
“…This difference is explained by different treatment modalities and confirms observations of other authors that higher RRs can be obtained with higher substitution and blood flow rates [ 16 , 21 , 22 ]. In the study reported by Ehlerding et al [ 13 ], substitution flow rates were set manually to around 70 mL/min, whereas in comPERFORM they were automatically set by the dialysis machines and reached a mean of 92 mL/min. In addition, blood flow was slightly higher in the comPERFORM study (∼325 mL/min versus 305 mL/min).…”
Section: Discussionmentioning
confidence: 99%
“…For the primary variable β2-m RR, the non-inferiority margin of −2% and the standard deviation were taken from earlier studies with FX CorAL 600 dialyzer and the number of patients needed for this cross-over study was estimated accordingly [ 13 , 14 ]. A total of independent patients were required, fixing the error level at α = 2.5% for a one-sided test and aiming at a power of 1 − β = 80%.…”
Section: Methodsmentioning
confidence: 99%
“…Two earlier clinical trials evaluated the safety and performance of FX CorAL [ 13 ]. The first compared FX CorAL with two other dialyzers of the FX series (FMC) while the second compared FX CorAL to SUREFLUX by Nipro and Polyflux by Baxter/Gambro (Deerfield, IL, USA).…”
Section: Introductionmentioning
confidence: 99%
“…Moreover, haemocompatibility analyses showed significantly lower C5a and sC5b-9 complement activation for FX CorAL than for two comparators from the FX series. Compared with Polyflux and SUREFLUX, FX CorAL activated complement sC5b-9 significantly less [ 13 ].…”
Background
Dialyzers shall be designed to efficiently eliminate uremic toxins during a dialysis treatment, given that the accumulation of small and middle molecular weight uremic solutes is associated with increased mortality risk of patients with end-stage renal disease. In the present study we investigated the novel FX CorAL dialyzer with a modified membrane surface for the performance during online-hemodiafiltration in a clinical setting.
Methods
comPERFORM was a prospective, open, controlled, multi-centric, interventional, cross-over study with randomized treatment sequences. It randomized stable patients receiving regular post-dilution online hemodiafiltration (HDF) to FX CorAL 600 (Fresenius Medical Care Deutschland GmbH), xevonta Hi 15 (B. Braun), and ELISIO 150H (Nipro), each for one week. The primary outcome was β2-microglobulin removal rate (ß2-m RR) during online-HDF. Secondary endpoints were RR and/or clearance of ß2-m and other molecules. Albumin removal over time was an exploratory endpoint. Non-inferiority and superiority of FX CorAL 600 vs. competitors were tested.
Results
52 patients were included and analyzed. FX CorAL 600 showed the highest ß2-m RR (75.47%), followed by xevonta Hi 15 (74.01%) and ELISIO 150H (72.70%). Superiority to its competitors was statistically significant (P = 0.0216 and P < 0.0001, respectively). Secondary endpoints related to middle molecules affirmed these results. FX CorAL 600 demonstrated the lowest albumin removal up to 60 min, and its sieving properties changed less over time than with competitors.
Conclusions
FX CorAL 600 efficiently removed middle and small molecules and was superior to the two comparators in ß2-m RR. Albumin sieving kinetics point to a reduced formation of a secondary membrane.
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