Clinical trial NCT02044614: Adjuvant Peritoneal Dialysis on a Background of Thrice-Weekly Hemodialysis
Official title: Adjuvant Peritoneal Dialysis on a Background of Thrice-Weekly Hemodialysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Functionally Anuric
Hemodialysis/Peritoneal Dialysis
Keywords: Hemodialysis/Peritoneal Dialysis
functionally anuric
Icodextrin
Kidney Disease Quality of Life
Lead sponsor: Davita Clinical Research
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2014-01-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.


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

Primary outcomes:
measure: Frequency of adverse events
timeFrame: Treatment Period (12 weeks)
measure: baseline-to-follow up changes in inter-HD weight gain
timeFrame: Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD
Secondary outcomes:
measure: baseline-to-follow up changes in HD dry weight (lowest tolerated at each time point)
timeFrame: Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD
measure: baseline-to-follow up changes in ambulatory blood pressures
timeFrame: Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD
measure: baseline-to-follow up changes in pre-HD serum phosphorus
timeFrame: Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD
measure: baseline-to-follow up changes in pre-to-post HD changes in serum potassium and total carbon dioxide (CO2)
timeFrame: Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD
measure: baseline-to-follow up changes in Kidney Disease Quality of Life Short Form (KDQoL-SF) scores for physical functioning, energy fatigue, and general health
timeFrame: Baseline, before the initiation of icodextrin-based PD, and at the end of the study after 12 weeks of icodextrin-based PD
Other outcomes:
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