Peritoneal dialysis (PD) is a well-established treatment for renal failure including long-term management of end stage renal disease (ESRD) by continuous ambulatory peritoneal dialysis or automated peritoneal dialysis (APD). Complementary therapies offer longer term survival for patients with ESRD. However, none of them are devoid of side effects and today their limitations are better understood by the nephrologist. The AMIA APD Solution Generation System combines an updated AMIA APD Cycler with Sharesource Platform (previously cleared) with an in-home water system technology and leverages newly developed AMIA APD Concentrates. The AMIA APD Concentrates, after dilution by the AMIA APD Solution Generation System, are indicated for adult patients in acute or chronic renal failure when non-dialytic medical therapy is judged to be inadequate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).
Investigational Site
Jonesboro, Arkansas, United States
Investigational Site
San Jose, California, United States
Investigational Site
Jacksonville, Florida, United States
Investigational Site
Chicago, Illinois, United States
Investigational Site
Ann Arbor, Michigan, United States
Investigational Site
Jackson, Mississippi, United States
Investigational Site
New York, New York, United States
Investigational Site
New York, New York, United States
Investigational Site
Cleveland, Ohio, United States
Investigational Site
Temple, Texas, United States
...and 1 more locations
Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit
The dialysis solution generated by the simulated treatment will be sampled from the heater bag, compared to the specifications of Baxter's approved low calcium Dianeal PD solution. The following 9 test methods will be analyzed: pH at 25 C, Color, 5- (hydroxymethyl)furfural (5HMF), Dextrose hydrous Assay (1.5%, 2.5% or 4.25%), Sodium Lactate Assay, Sodium Assay, Chloride Assay, Magnesium Chloride Hexahydrate (MgCl2.6H2O) Assay, and Calcium Chloride Dihydrate (CaCl2.2H2O) Assay. Measurements were collected using instruments such as meters, chromatography, etc. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications.
Time frame: Week 1, 4, 8 and 12
Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit
Microbiological testing within \<=0 CFU/mL limit for total aerobic microbial count (TAMC) and total yeast/mold count (TYMC) and \<0.03 EU/mL limit for Endotoxins, and chemical parameters. Product water from the WD (pre-sterilizing filters) was collected and tested for microbiological (including endotoxin) contamination per USP \<61\> and USP \<85\> and chemical contaminants according to ISO 13959. Chemical parameters include aluminum, copper, fluoride, lead, nitrate, sulphate, zinc, calcium, magnesium, potassium, sodium, antimony, arsenic, barium, beryllium, cadmium, chromium, mercury, selenium, silver, thallium, nickel, cobalt, total chlorine. Chemical measurements were collected using instruments such as meters, chromatography, etc. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications.
Time frame: Week 1, 4, 8 and 12
Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit
Microbiological testing within \<=0 CFU/mL limit for TAMC and TYMC and \<0.03 EU/mL limit for Endotoxins. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications. A test was considered as meeting specifications if all of the following parameters fell within the specified limits: tryptic soy broth growth, fluid thioglycolate growth, and endotoxins. Water in the holding bag was collected and tested for microbiological contamination and endotoxin levels per USP \<71\> and USP \<85\>.
Time frame: Week 1, 4, 8 and 12
Change From Baseline in Total Kt/Vurea at Week 5, 6, 7, or 8
Peritoneal dialysis adequacy will be measured by sample collection and calculation of Total Kt/Vurea. Weekly peritoneal Kt/Vurea was calculated from blood and 24-hour PD effluent samples and renal Kt/Vurea was calculated from 24-hour collection of urine samples (if applicable) and blood samples after the patient had been dialyzing with the AMIA APD Solution Generation System for at least 4 weeks. Total Kt/Vurea is the sum of peritoneal Kt/Vurea and renal Kt/Vurea. Note: This secondary efficacy endpoint was measured by sample collection and calculation of total Kt/Vurea, occurring one time during Week 5, 6, 7, or 8 of the Study Treatment Period.
Time frame: Baseline, Week 5 or Week 6 or Week 7 or Week 8
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