Adjuvant Peritoneal Dialysis on a Background of Thrice-Weekly Hemodialysis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Davita Clinical Research
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Davita Clinical Research
ClinicalTrials.gov Identifier:
NCT02044614
First received: January 10, 2014
Last updated: April 15, 2014
Last verified: April 2014
  Purpose
  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.

Condition Intervention
Functionally Anuric
Hemodialysis/Peritoneal Dialysis
Other: Adjuvant Peritoneal Dialysis in the context of ongoing Hemodialysis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Adjuvant Peritoneal Dialysis on a Background of Thrice-Weekly Hemodialysis

Resource links provided by NLM:


Further study details as provided by Davita Clinical Research:

Primary Outcome Measures:
  • Frequency of adverse events [ Time Frame: Treatment Period (12 weeks) ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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-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 ] [ Designated as safety issue: No ]
    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-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 ] [ Designated as safety issue: No ]
    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-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 ] [ Designated as safety issue: No ]
    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-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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 25
Study Start Date: May 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Davita Clinical Research
ClinicalTrials.gov Identifier: NCT02044614     History of Changes
Other Study ID Numbers: DCR-BXT-2013-01
Study First Received: January 10, 2014
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Davita Clinical Research:
Hemodialysis/Peritoneal Dialysis
functionally anuric
Icodextrin
Kidney Disease Quality of Life

Additional relevant MeSH terms:
Icodextrin
Dialysis Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014