NCT03812679

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease (ESRD)

Interventions

Type	Name	Description
DEVICE	AMIA APD Solution Generation System	The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).

Timeline

• Start date: 2018-12-20
• Primary completion: 2020-02-19
• Completion: 2020-02-19
• First posted: 2019-01-23
• Last updated: 2025-07-14
• Results posted: 2021-02-05

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study