Adjuvant Peritoneal Dialysis on a Background of Thrice-Weekly Hemodialysis

Study Overview
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Brief Summary
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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. 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: reduce inter-hemodialytic weight gain* enable achievement of lower hemodialytic dry weight reduce total body water improve ambulatory blood pressure control reduce serum phosphorus minimize per-hemodialytic changes in serum potassium and pH have favorable effects on indices of physical function and global health Indicates co-primary outcomes.

Official Title
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Adjuvant Peritoneal Dialysis on a Background of Thrice-Weekly Hemodialysis

Conditions
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Functionally Anuric, Hemodialysis/Peritoneal Dialysis

Intervention / Treatment
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* Other: Adjuvant Peritoneal Dialysis in the context of ongoing Hemodialysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: icodextrin-based peritoneal dialysis to hemodialysis<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| baseline-to-follow up changes in HD dry weight (lowest tolerated at each time point) | 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 | 
| baseline-to-follow up changes in ambulatory blood pressures | 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 | 
| baseline-to-follow up changes in pre-HD serum phosphorus | 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 | 
| baseline-to-follow up changes in pre-to-post HD changes in serum potassium and total carbon dioxide (CO2) | 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 | 
| baseline-to-follow up changes in Kidney Disease Quality of Life Short Form (KDQoL-SF) scores for physical functioning, energy fatigue, and general health | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis/Peritoneal Dialysis, functionally anuric, Icodextrin, Kidney Disease Quality of Life