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Directed Use of REmote Patient Management System AMia to Achieve Prescribed Dry Weight

NCT04002440 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-08-25

No results posted yet for this study

Summary

Among ambulatory peritoneal dialysis patients, does use of the Baxter AMIA peritoneal dialysis cycler with SHARESOURCE connectivity platform achieve dry weight targets better than use of the Baxter Home Choice Pro cycler.

Conditions

  • Efficacy
  • Safety Issues

Interventions

COMBINATION_PRODUCT

AMIA with SHARESOURCE Connectivity Platform

The investigators will conduct a randomized, cross-over study in peritoneal dialysis patients in which patients are randomized to either Home Choice Pro (which remains the most widely used Baxter cycler) versus treatment with the Baxter AMIA automated peritoneal dialysis system with SHARESOURCE connectivity.

DEVICE

HomeChoice PRO

Usual care

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Scripps Health

    collaborator OTHER

  • Home Dialysis Therapies of San Diego

    collaborator UNKNOWN

  • University of California, San Diego

    lead OTHER

Principal Investigators

  • Joachim H Ix, MD, MAS · University of California, San Diego

  • Bethany E Karl, DO · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-08
Primary Completion
2021-11-30
Completion
2022-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04002440 on ClinicalTrials.gov