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

NCT04002440 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 180492
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Estimated Dry Weight; Peritoneal Dialysis; AMIA; Sharesource; CCPD; Peritoneal Dialysis Cycler; HomeChoice PRO

Outcome Measures

Primary Outcomes (1)

• 3 month average of difference between the actual vs. prescribed dry weight

  The investigators will evaluate the average difference between the actual dry weight vs. prescribed dry weight achieved through use of Baxter AMIA automated peritoneal dialysis system with SHARESOURCE connectivity compared to use of HomeChoicePRO.

  3 months

Secondary Outcomes (2)

• Nursing burden related to use of AMIA with SHARESOURCE

  12 months

• Patient Quality of Life while using AMIA with SHARESOURCE: Kidney Disease and Quality of Life -36 questionaire

  12 months

Study Arms (2)

AMIA with SHARESOURCE

ACTIVE COMPARATOR

For this arm, dialysis nurses will review those patients using the AMIA with SHARESOURCE connectivity platform twice a week and will contact patients who meet certain triggers. They will then offer patients interventions, ie. a change in the preset AMIA ultrafiltration program, in order to achieve prescribed dry weight.

Combination Product: AMIA with SHARESOURCE Connectivity Platform

HomeChoice PRO

PLACEBO COMPARATOR

For this arm, routine standard of care for peritoneal dialysis patients will continue using the HomeChoice PRO device. Data regarding treatments will be captured on a chip to be analyzed at the end of 6 months to evaluate compliance with treatments.

Device: HomeChoice PRO

Interventions

AMIA with SHARESOURCE Connectivity Platform COMBINATION_PRODUCT

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.

Also known as: Baxter AMIA, SHARESOURCE

AMIA with SHARESOURCE

HomeChoice PRO DEVICE

Usual care

Also known as: Baxter HomeChoice PRO

HomeChoice PRO

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged \> 21 years with ESRD on peritoneal dialysis

You may not qualify if:

• Unable to commit to 12 months of monitoring.
• Unable to stand safely on scale for weight
• Hospitalization for heart failure, volume overload, or cardiovascular disease within the last 3 months.
• Peritonitis within the past 3 months.
• Not responsible for self-care of peritoneal dialysis (proxy care will be excluded).
• Patients residing in a nursing home or other institutionalized individuals.
• Inability or unwillingness to provide informed consent (lacks decision making capacity)
• Alcohol, substance use, or other social conditions which preclude close follow-up and reliable participation, in the opinion of the primary nephrology physician or study investigator.

Sponsors & Collaborators

• University of California, San Diego: lead
• Baxter Healthcare Corporation: collaborator
• Scripps Health: collaborator
• Home Dialysis Therapies of San Diego: collaborator

Study Sites (2)

Home Dialysis Therapies of San Diego

Chula Vista, California, 91915, United States

Location

Home Dialysis Therapies of San Diego

San Diego, California, 92131, United States

Location

Study Officials

• Joachim H Ix, MD, MAS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Bethany E Karl, DO

  University of California, San Diego

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study is not blinded, as the intervention does not provide an opportunity to blind either the physician or the patient. The PI will be masked to randomization and not involved in patient care or data collection. Statistical analyses will be conducted by Dr. Ronit Katz who is not an investigator for this trial and PI Dr.Joachim Ix after being provided secure study results.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Participants will be consented and then randomized to one of 2 modality groups; AMIA or HomeChoice PRO. Participants will receive PD care with randomized modality for 6 months, then cross-over to other modality for next 6 months. Nephrologists will see patients once a month. Each visit, the nephrologist will define the patient's desired dry weight (DW) at the subsequent visit. The primary end-point will be the average difference between actual DW vs. prescribed DW. The investigators envision a learning curve with each cycler change, and therefore have set the primary endpoint to average the final 3 visits, rather than using all 6 visits. All solutions and supplies will be from Baxter. Labs will be obtained monthly and quarterly per routine. Dialysis RN will review patients on AMIA twice a week and contact those off target DW and offer interventions to achieve prescribed DW. HomeChoice PRO will record data on a chip analyzed at the end of 6 months to evaluate compliance.

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: June 28, 2019
• Study Start: November 8, 2018
• Primary Completion: November 30, 2021
• Study Completion: April 1, 2022
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

US (2)