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Adjuvant Peritoneal Dialysis on a Background of Thrice-Weekly Hemodialysis

NCT02044614 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2016-08-17

No results posted yet for this study

Summary

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.

Conditions

  • Functionally Anuric
  • Hemodialysis/Peritoneal Dialysis

Interventions

OTHER

Adjuvant Peritoneal Dialysis in the context of ongoing Hemodialysis

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Davita Clinical Research

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-04-30
Completion
2016-04-30

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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 NCT02044614 on ClinicalTrials.gov