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Performance Evaluation of the AMIA APD Solution Generation System in Patients End Stage Renal Disease (ESRD)

End Stage Renal Disease (ESRD) Clinical Trial

Official title:
Performance Evaluation of the AMIA Automated Peritoneal Dialysis (APD) Solution Generation System in Patients Using the AMIA APD Cycler

Clinical Trial Summary

Peritoneal dialysis (PD) is a well-established treatment for renal failure including long-term management of end stage renal disease (ESRD) by continuous ambulatory peritoneal dialysis or automated peritoneal dialysis (APD). Complementary therapies offer longer term survival for patients with ESRD. However, none of them are devoid of side effects and today their limitations are better understood by the nephrologist. The AMIA APD Solution Generation System combines an updated AMIA APD Cycler with Sharesource Platform (previously cleared) with an in-home water system technology and leverages newly developed AMIA APD Concentrates. The AMIA APD Concentrates, after dilution by the AMIA APD Solution Generation System, are indicated for adult patients in acute or chronic renal failure when non-dialytic medical therapy is judged to be inadequate.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03812679
Study type Interventional
Source Baxter Healthcare Corporation
Contact
Status Terminated
Phase N/A
Start date December 20, 2018
Completion date February 19, 2020
View Details
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