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GFW 044
GFW 044
doi: 10.1093/ndt/gfw044
Advance Access publication 7 April 2016
Original Articles
SafetyandperformanceofVIVIA 687
patients were eligible if they were on nocturnal HD thrice man study and 298 in the extended-duration study). Baseline
||
weekly for at least 30 days prior to entry into this study. || and in-study treatment parameters for both studies are shown
The study consisted of a 2-week screening period and a 6- || in Table 2. Heparin dose was determined by measuring the
||
week treatment period where patients were treated thrice || aPTT ratio. In the first-in-man study, the mean [6 standard
weekly for 6–8 h/treatment. The first week of the treatment || deviation (SD)] aPTT was 2.42 6 0.59 times higher than base-
||
period was used to stabilize patients on their new prescriptions. || line after initial heparin infusion and 1.64 6 0.45 higher than
The performance of the VIVIA Treatment Device was assessed || baseline before the end of treatment. In the extended duration
||
during the last 5 weeks (evaluable period). || study, the mean (6SD) aPTT was 2.26 6 1.01 times higher
A new blood set and dialyzer were used at the beginning of || than baseline after initial heparin infusion and 2.42 6 1.32
||
the 5-week evaluable period and the conditions for the multiple || times higher before the end of treatment. Notably, dialysate
use of the dialyzer were similar to those used in the first-in-man || flow rates were lower during both studies than before study
||
study. Safety data were collected during the entire 6-week treat- || entry and the heparin loading dose and total heparin infusion
ment period in a manner similar to that employed during the || requirements increased from baseline.
||
first study. Definitions for AEs were the same in both studies. ||
Performance of the VIVIA Treatment Device was also deter- ||
|| Safety
mined by assessment of dialysis dose and ultrafiltration. In this ||
SafetyandperformanceofVIVIA 689
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FIGURE 3: The Bland–Altman plot of fluid weight removed plotted versus weight change for treatments during (A) the first-in-man clinical
study and (B) the extended-duration clinical study.
generation and water consumption while ensuring efficient sol- patients were able to achieve 10 or more uses from the same
||
ute clearance using a modern high-flux dialyzer. || VIVIA Dialyzer and Blood Set, a feature that reduces the bur-
VIVIA also performed ultrafiltration as desired. The correla- || den of therapy on the patient and/or care partner. As shown in
||
tion between fluid weight removed and weight change was || Table 3, the variability within and among patients was consider-
strong and consistent across both clinical studies. The use of || able. Extended use of the same dialyzer and blood set was
||
digital calibrated scales and measurement of all fluid input and || improved with optimized anticoagulation using the aPTT as a
output allowed us to tease out the amount of insensible fluid || guide [13, 14].
||
loss during HD treatments [22–24]. Although this varied || These studies are not without limitations. Control groups
among patients, the median insensible fluid loss for mean 4- || were not used in either study. Although clinical studies are not
||
and 7-h treatments was 200 and 300 mL, respectively. Given || required for the majority of HD devices prior to their commer-
that each patient’s weight did not change throughout both clini- || cial launch, we designed these studies to meet regulatory guid-
||
cal studies, it is unlikely that insensible fluid loss has any clinical || ance. The studies were also performed in in-center settings and
relevance in the management of HD patients. || not the home environment. Although VIVIA is specifically
||
The studies demonstrated the feasibility of extended use of ||| designed for the home, rigorous performance testing is difficult
the VIVIA Dialyzer and Blood Set for multiple treatments using || to perform in the home setting, where additional nondevice fac-
nonchemical in situ hot-water disinfection. The majority of || tors may impact safety and performance. The duration of each
Treatments Dialyzers Maximum use count Treatments Dialyzers Maximum use count
1 2 2 1 19 3 17
2 35 23 5 15 9 5
3 34 26 4 18 14 3
4 35 4 24 18 7 10
5 33 11 9 18 2 13
6 32 5 23 18 2 17
7 32 6 13 16 8 4
8 32 9 19 18 3 15
9 34 20 8 18 3 10
10 31 7 8 18 3 13
11 32 4 13 17 5 10
12 32 11 9 18 4 12
13 30 26 5 18 5 7
14 31 9 11 17 10 5
study was also too short to determine long-term safety and clin-
ical effectiveness. Future studies are planned to gather these || CONFLICT OF INTEREST STATEMENT
||
data. It should also be noted that more accurate formulas for ||
calculating stdKt/V for HD therapies applied more frequently || A.B., M.A., J.K.L., M.M., R.S. and B.C. are full-time employees
|| of Baxter Healthcare Corporation with ownership interests.
than thrice weekly have only recently been published [25, 26]; ||
however, use of such formulas using data from the first-in-man || A.H. was a full-time employee of Baxter Healthcare
|| Corporation at the time of the study. P.M. has been a consul-
clinical study resulted in minor differences that would not alter ||
tant for and received research funding from Baxter
conclusions regarding the ability to achieve an adequate dialysis |||
dose [27]. || Healthcare Corporation.
||
In conclusion, data from these two clinical studies conducted ||
in prevalent HD patients confirm the safety and expected per- ||
||
formance of VIVIA. || REFERENCES
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ACKNOWLEDGEMENTS || Kidney Disease and End-Stage Renal Disease in the United States. Bethesda,
||
|| MD: National Institutes of Health, National Institute of Diabetes and
These studies were supported by Baxter Healthcare || Digestive and Kidney Diseases, 2013
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