Adjuvant Peritoneal Dialysis on a Background of Thrice-Weekly Hemodialysis

August 15, 2016 updated by: Davita Clinical Research

  1. To assess the feasibility and safety of applying a 12-week course of adjuvant low-frequency icodextrin-based peritoneal dialysis to an ongoing regimen of thrice-weekly in-center hemodialysis.

    Hypothesis: Icodextrin-based peritoneal dialysis can be safely and feasibly implemented in the context of ongoing thrice-weekly in-center hemodialysis.

  2. To measure the effects of a 12-week course of adjuvant low-frequency icodextrin-based peritoneal dialysis to ongoing thrice-weekly maintenance hemodialysis on: inter-hemodialytic weight gain, achievable hemodialytic dry weight, total body water, ambulatory blood pressure, serum phosphorus, and pre-to-post hemodialysis changes in serum potassium and pH, and Kidney Disease Quality of Life-SF physical functioning, energy fatigue, and general health scores.

Hypotheses: Addition of adjuvant icodextrin-based peritoneal dialysis will:

  1. reduce inter-hemodialytic weight gain*
  2. enable achievement of lower hemodialytic dry weight
  3. reduce total body water
  4. improve ambulatory blood pressure control
  5. reduce serum phosphorus
  6. minimize per-hemodialytic changes in serum potassium and pH

  7. have favorable effects on indices of physical function and global health

    • Indicates co-primary outcomes.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients who are functionally anuric (urine volume <100ml/day)
  • receiving chronic maintenance dialysis for treatment of end-stage renal disease
  • transitioning from hemodialysis (HD) to peritoneal dialysis (PD)
  • transitioning from PD to HD
  • receiving PD and have a functional arteriovenous access already in place

Exclusion Criteria:

  • < 18 years of age
  • anticipate living related kidney transplant or transfer of care away from a participating unit within the next 6 months
  • have anticipated survival <6 months
  • have contraindications to PD therapy
  • history of complicated bowel or abdominal aortic surgery
  • known abdominal wall defects
  • pregnancy (including pre-menopausal women not surgically sterilized or on hormonal contraception)
  • indwelling trans-abdominal prosthetic devices (e.g., feeding or biliary tubes)
  • known hypersensitivity to peritoneal dialysate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: icodextrin-based peritoneal dialysis to hemodialysis
12-week course of adjuvant low-frequency icodextrin-based peritoneal dialysis to ongoing thrice-weekly maintenance hemodialysis
Other: Adjuvant Peritoneal Dialysis in the context of ongoing Hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of adverse events
Time Frame: Treatment Period (12 weeks)
Adverse events will be described qualitatively and tabulated by frequency. Levels of icodextrin metabolites (considered individually and in aggregate) will be examined graphically and described in terms of means, standard deviations, medians, inter-quartile ranges, minimums and maximums. In Phase I, the association between Δpre-HD serum osmolality (ie, current pre-HD osmolality-pre-HD osmolality preceding the first icodextrin exchange) and aggregate icodextrin metabolites will be examined graphically and by simple linear regression. The association between pre-to-post-HD changes and serum osmolality and pre-to-post-HD changes in aggregate icodextrin levels will be examined analogously.
Treatment Period (12 weeks)
baseline-to-follow up changes in inter-HD weight gain
Time Frame: Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD

Efficacy outcomes will be examined using a self-controlled paradigm considering change in outcome parameters from baseline (ie, on HD alone) to follow up (ie, on HD+PD)

In most instances, characterization visits will take place following the next hemodialysis treatment, but may be delayed by 1-2 treatments based on pragmatic considerations (appointment availability, day of the week).
Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
baseline-to-follow up changes in HD dry weight (lowest tolerated at each time point)
Time Frame: Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD
In most instances, characterization visits will take place following the next hemodialysis treatment, but may be delayed by 1-2 treatments based on pragmatic considerations (appointment availability, day of the week).
Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD
baseline-to-follow up changes in ambulatory blood pressures
Time Frame: Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD
In most instances, characterization visits will take place following the next hemodialysis treatment, but may be delayed by 1-2 treatments based on pragmatic considerations (appointment availability, day of the week).
Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD
baseline-to-follow up changes in pre-HD serum phosphorus
Time Frame: Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD
In most instances, characterization visits will take place following the next hemodialysis treatment, but may be delayed by 1-2 treatments based on pragmatic considerations (appointment availability, day of the week).
Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD
baseline-to-follow up changes in pre-to-post HD changes in serum potassium and total carbon dioxide (CO2)
Time Frame: Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD
In most instances, characterization visits will take place following the next hemodialysis treatment, but may be delayed by 1-2 treatments based on pragmatic considerations (appointment availability, day of the week).
Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD
baseline-to-follow up changes in Kidney Disease Quality of Life Short Form (KDQoL-SF) scores for physical functioning, energy fatigue, and general health
Time Frame: Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD
In most instances, characterization visits will take place following the next hemodialysis treatment, but may be delayed by 1-2 treatments based on pragmatic considerations (appointment availability, day of the week).
Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Davita Clinical Research

Collaborators

Baxter Healthcare Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (ESTIMATE)

January 24, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 15, 2016

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DCR-BXT-2013-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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