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

NCT03812679 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-07-14

Study results available
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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

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).

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Vantive Health LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2020-02-19
Completion
2020-02-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03812679 on ClinicalTrials.gov