Adjuvant Peritoneal Dialysis on a Background of Thrice-Weekly Hemodialysis

NCT02044614 | Terminated DMC

• 1 other identifier: DCR-BXT-2013-01
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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.
2. 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.
3. 3.reduce inter-hemodialytic weight gain\*
4. 4.enable achievement of lower hemodialytic dry weight
5. 5.reduce total body water
6. 6.improve ambulatory blood pressure control
7. 7.reduce serum phosphorus
8. 8.minimize per-hemodialytic changes in serum potassium and pH
9. 9.have favorable effects on indices of physical function and global health
10. 10.Indicates co-primary outcomes.

Conditions

Functionally Anuric; Hemodialysis/Peritoneal Dialysis

Keywords

Hemodialysis/Peritoneal Dialysis; functionally anuric; Icodextrin; Kidney Disease Quality of Life

Outcome Measures

Primary Outcomes (2)

• Frequency of adverse events

  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

  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 Outcomes (5)

• baseline-to-follow up changes in HD dry weight (lowest tolerated at each time point)

  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

  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

  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)

  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

  Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD

Study Arms (1)

icodextrin-based peritoneal dialysis to hemodialysis

OTHER

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

Interventions

Adjuvant Peritoneal Dialysis in the context of ongoing Hemodialysis OTHER

icodextrin-based peritoneal dialysis to hemodialysis

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Davita Clinical Research: lead
• Baxter Healthcare Corporation: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 24, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 17, 2016

Record last verified: 2014-04