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Clinical Trial
Allient® Sorbent Hemodialysis System Home Use Clinical Trial
Renal Solutions is currently conducting a Home Clinical Safety Research Study to obtain FDA clearance for home use indication. On September 2007, Renal Solutions initiated a home use clinical research study using sorbent technology. The study presents the opportunity for 25 dialysis study participants to evaluate the ability to self-administer extended-duration dialysis in the home when using the Allient® Sorbent Hemodialysis System (Allient System). In this study, the use of the Allient System in the home is an investigational use.
Renal Solutions announces that a home dialysis clinical research study has begun using sorbent technology.
The Allient® Sorbent Hemodialysis System Home Use Clinical Trial Protocol
The Allient Sorbent Hemodialysis System, including the SORB™ HD and HISORB™ HD series cartridges, is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.
The objective of the study is to demonstrate that the safety of the Allient System, when used to provide dialysis for stable, chronic ESRD subjects per instructions in the home environment, is substantially equivalent to the safety of the Allient System when used per instructions in the hospital, clinic, or monitored professional care environment.
The study is an open-label, prospective, nonrandomized, pseudo-crossover design that tests two treatment regimens. Each subject will participate in two treatment phases in the order shown:
- In-clinic dialysis with the Allient System
- In-home dialysis with the Allient System
Each treatment phase will be 8 weeks in length with each subject following the same dialysis schedule during both phases. There will be a follow-up visit within three days of the last in-clinic or in-home dialysis treatment on the Allient System. Barring the necessity for service, etc., it is intended that each subject will be assigned an Allient System, and will use this assigned device for both treatment phases. During the in-clinic phase of the study, subjects will receive training on the use of the Allient System.
The subject population will include stable, chronic ESRD dialysis subjects, a minimum of 18 years old, who have been stable on traditional (single-pass) hemodialysis therapy. A minimum of 25 subjects will be enrolled. Enough subjects will be enrolled to ensure that 25 subjects complete both the in-clinic and the in-home phases of the study.