Adjuvant Peritoneal Dialysis on a Background of Thrice-Weekly Hemodialysis

NCT ID: NCT02044614

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-04-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

icodextrin-based peritoneal dialysis to hemodialysis

12-week course of adjuvant low-frequency icodextrin-based peritoneal dialysis to ongoing thrice-weekly maintenance hemodialysis

Group Type: OTHER

Adjuvant Peritoneal Dialysis in the context of ongoing Hemodialysis

Intervention Type: OTHER

Interventions

Adjuvant Peritoneal Dialysis in the context of ongoing Hemodialysis

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Davita Clinical Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

DCR-BXT-2013-01

Identifier Type: -

Identifier Source: org_study_id