Adjuvant Peritoneal Dialysis on a Background of Thrice-Weekly Hemodialysis

DaVita

Status: Terminated

Conditions: Hemodialysis/Peritoneal Dialysis; Functionally Anuric

Treatments: Other: Adjuvant Peritoneal Dialysis in the context of ongoing Hemodialysis

Study type: Interventional

Funder types: Industry

Identifiers

NCT02044614

DCR-BXT-2013-01

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1 participants in 1 patient group

icodextrin-based peritoneal dialysis to hemodialysis

Other group

Description:

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

Treatment:

Other: Adjuvant Peritoneal Dialysis in the context of ongoing Hemodialysis