Trial Outcomes & Findings for Performance Evaluation of the AMIA APD Solution Generation System in Patients End Stage Renal Disease (ESRD) (NCT NCT03812679)
NCT ID: NCT03812679
Last Updated: 2025-07-14
Results Overview
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.
TERMINATED
NA
22 participants
Week 1, 4, 8 and 12
2025-07-14
Participant Flow
Participant milestones
| Measure |
AMIA APD Solution Generation System
A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.
AMIA APD Solution Generation System: 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).
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|---|---|
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Overall Study
STARTED
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22
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Overall Study
COMPLETED
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14
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Overall Study
NOT COMPLETED
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8
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Reasons for withdrawal
| Measure |
AMIA APD Solution Generation System
A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.
AMIA APD Solution Generation System: 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).
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|---|---|
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Overall Study
Adverse Event
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2
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Overall Study
Missed >4 consecutive therapy days
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1
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Overall Study
Renal transplant
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1
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Termination of study
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2
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Overall Study
Water device replacement
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1
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Baseline Characteristics
Performance Evaluation of the AMIA APD Solution Generation System in Patients End Stage Renal Disease (ESRD)
Baseline characteristics by cohort
| Measure |
AMIA APD Solution Generation System
n=22 Participants
A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.
AMIA APD Solution Generation System: 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).
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|---|---|
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Age, Continuous
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61.9 years
STANDARD_DEVIATION 13.67 • n=99 Participants
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Sex: Female, Male
Female
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14 Participants
n=99 Participants
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Sex: Female, Male
Male
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8 Participants
n=99 Participants
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Race/Ethnicity, Customized
Asian
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5 Participants
n=99 Participants
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Race/Ethnicity, Customized
Black or African American
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7 Participants
n=99 Participants
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Race/Ethnicity, Customized
White
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9 Participants
n=99 Participants
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Race/Ethnicity, Customized
Other
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1 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Week 1, 4, 8 and 12Population: Safety Set used for analysis population. Also, Overall Number of Tests Analyzed (N) was captured, along with number of evaluable tests (n) for each individual timepoint.
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.
Outcome measures
| Measure |
AMIA APD Solution Generation System
n=71 Tests
A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.
AMIA APD Solution Generation System: 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).
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|---|---|
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Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit
Week 8 (4.25% Dextrose): Met Specifications
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85.7 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit
Week 1 (1.5% Dextrose): Met Specifications
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91.3 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit
Week 1 (1.5% Dextrose): Did Not Meet Specifications
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0 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit
Week 1 (1.5% Dextrose): Missing Results
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8.7 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit
Week 4 (2.5% Dextrose): Met Specifications
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95 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit
Week 4 (2.5% Dextrose): Did Not Meet Specifications
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0 Percentage of Tests
|
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Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit
Week 4 (2.5% Dextrose): Missing Results
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5 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit
Week 8 (4.25% Dextrose): Did Not Meet Specifications
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0 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit
Week 8 (4.25% Dextrose):Missing Results
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14.3 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit
Week 12 (1.5% Dextrose): Met Specifications
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85.7 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit
Week 12 (1.5% Dextrose): Did Not Meet Specifications
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0 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit
Week 12 (1.5% Dextrose): Missing Results
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14.3 Percentage of Tests
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PRIMARY outcome
Timeframe: Week 1, 4, 8 and 12Population: Safety Set used for analysis population. Also, Overall Number of Tests Analyzed (N) was captured, along with number of evaluable tests (n) for each individual timepoint.
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.
Outcome measures
| Measure |
AMIA APD Solution Generation System
n=72 Tests
A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.
AMIA APD Solution Generation System: 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).
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|---|---|
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Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit
Week 1(Visit 1): Met Specifications
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37.5 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit
Week 1(Visit 1): Did Not Meet Specifications
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0 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit
Week 1(Visit 1): Missing Results
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62.5 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit
Week 4 (Visit 2): Met Specifications
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60 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit
Week 4 (Visit 2): Did Not Meet Specifications
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15 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit
Week 4 (Visit 2): Missing Results
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25 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit
Week 8 (Visit 3): Met Specifications
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78.6 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit
Week 8 (Visit 3): Did Not Meet Specifications
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7.1 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit
Week 8 (Visit 3): Missing Results
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14.3 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit
Week 12 (Visit 4): Met Specifications
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64.3 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit
Week 12 (Visit 4): Did Not Meet Specifications
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14.3 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit
Week 12 (Visit 4): Missing Results
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21.4 Percentage of Tests
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PRIMARY outcome
Timeframe: Week 1, 4, 8 and 12Population: Safety Set used for analysis population. Also, Overall Number of Tests Analyzed (N) was captured, along with number of evaluable tests (n) for each individual timepoint.
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\>.
Outcome measures
| Measure |
AMIA APD Solution Generation System
n=71 Tests
A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.
AMIA APD Solution Generation System: 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).
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|---|---|
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Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit
Week 1 (Visit 1): Met Specifications
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100 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit
Week 1 (Visit 1): Did Not Meet Specifications
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0 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit
Week 1 (Visit 1): Missing Results
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0 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit
Week 4 (Visit 2): Met Specifications
|
100 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit
Week 4 (Visit 2): Did Not Meet Specifications
|
0 Percentage of Tests
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|
Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit
Week 4 (Visit 2): Missing Results
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0 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit
Week 8 (Visit 3): Met Specifications
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92.9 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit
Week 8 (Visit 3): Did Not Meet Specifications
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0 Percentage of Tests
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|
Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit
Week 8 (Visit 3): Missing Results
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7.1 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit
Week 12 (Visit 4): Met Specifications
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85.7 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit
Week 12 (Visit 4): Did Not Meet Specifications
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0 Percentage of Tests
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Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit
Week 12 (Visit 4): Missing Results
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14.3 Percentage of Tests
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SECONDARY outcome
Timeframe: Baseline, Week 5 or Week 6 or Week 7 or Week 8Population: Safety Set
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.
Outcome measures
| Measure |
AMIA APD Solution Generation System
n=15 Participants
A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.
AMIA APD Solution Generation System: 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).
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|---|---|
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Change From Baseline in Total Kt/Vurea at Week 5, 6, 7, or 8
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-0.15 Kt/Vurea
Standard Deviation 0.370
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Adverse Events
AMIA APD Solution Generation System
Serious adverse events
| Measure |
AMIA APD Solution Generation System
n=22 participants at risk
A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.
AMIA APD Solution Generation System: 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).
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|---|---|
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Cardiac disorders
Atrial fibrillation
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4.5%
1/22 • Number of events 1 • AEs and SAEs will be collected after the informed consent is signed and will continue to be collected throughout the Study Treatment Period and during the follow-up period of 5 days after the last study treatment.
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Infections and infestations
Peritonitis
|
4.5%
1/22 • Number of events 1 • AEs and SAEs will be collected after the informed consent is signed and will continue to be collected throughout the Study Treatment Period and during the follow-up period of 5 days after the last study treatment.
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|
Infections and infestations
Peritonitis bacterial
|
4.5%
1/22 • Number of events 1 • AEs and SAEs will be collected after the informed consent is signed and will continue to be collected throughout the Study Treatment Period and during the follow-up period of 5 days after the last study treatment.
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Other adverse events
| Measure |
AMIA APD Solution Generation System
n=22 participants at risk
A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.
AMIA APD Solution Generation System: 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).
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|---|---|
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Vascular disorders
Hypotension
|
9.1%
2/22 • Number of events 2 • AEs and SAEs will be collected after the informed consent is signed and will continue to be collected throughout the Study Treatment Period and during the follow-up period of 5 days after the last study treatment.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor reserves the right of prior review and approval of data from this study relative to the potential release of proprietary information to any publication or for any presentation.
- Publication restrictions are in place
Restriction type: OTHER