Status:
TERMINATED
Performance Evaluation of the AMIA APD Solution Generation System in Patients End Stage Renal Disease (ESRD)
Lead Sponsor:
Vantive Health LLC
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
End Stage Renal Disease (ESRD)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 pe...
Eligibility Criteria
Inclusion
- Patient is 18 years or older.
- Patient with ESRD receiving PD therapy, and who is already trained and regularly using the AMIA or HomeChoice APD Cycler with Dianeal PD Solution for at least 12 weeks.
- Patient is receiving or willing and able to use Dianeal Low Calcium (2.5 mEq/L) PD prescriptive regimen at study treatment initiation per Investigator's assessment.
- Patient demonstrates adequate PD therapy with clinical euvolemia as assessed by the Investigator with a total Kt/Vurea of a minimum of 1.7 within 45 days of Screening, or measured at Screening. If a total Kt/Vurea is not available within 45 days of Screening, it will be measured at Screening.
- Investigator assesses that, with appropriate training, the patient will be able to successfully manage his/her dialysis treatments with the AMIA APD Solution Generation System.
- Patient is available and is willing to complete training on the AMIA APD Solution Generation System.
- Patient and home environment are deemed suitable for treatment with the AMIA APD Solution Generation System, while in the home.
- Home electrical and water assessments meet suitability criteria for the AMIA APD Solution Generation System.
- The patient's home has suitable wireless connection or patient is willing to allow installation of suitable wireless connection.
- Patient and/or care partner (if participating) is able to read and understand English, and provide informed consent after an explanation of the proposed study. If the patient does not read and understand English, patient may still participate if he/she has a co-residing care partner who reads and understands English, assessed as adequate by the PI.
- Women of childbearing potential (not menopausal or surgically sterile) must not be pregnant. Serum qualitative and quantitative pregnancy test will be done within 14 days prior to initiation of study product.
- If qualitative serum β-hCG results are positive, repeat quantitative serum pregnancy test in 48 hours.
- If quantitative serum β-hCG levels show clinically significant rise within 48 hours, serum progesterone level should be taken. Serum progesterone \> 5 ng/mL will exclude a patient from the study.
- Sexually active males and females agree to use a reliable means of contraception during the study and for 30 days afterwards (e.g., oral contraceptive and condom, intrauterine device and condom, or diaphragm with spermicide and condom).
Exclusion
- Patient with a history of PD catheter dysfunction within 12 weeks prior to study enrollment, as evaluated by the Investigator.
- Patient who had episodes of peritonitis or exit site infection within 12 weeks prior to study enrollment.
- Patient who has signs of impending or current infection including a cloudy dialysis effluent or dialysis white cell count \> 100/ μL or \> 0.1 x 109/ L (after a dwell time of at least 2 hours), with \> 50% polymorphonuclear cells, and/or positive dialysis effluent culture.
- Patient who has a severe primary immune deficiency or other condition that may mask clinical signs of peritonitis, as evaluated by the Investigator.
- Patient with a history of repeated non-compliance with PD, therapy (e.g., a substantial number of missed clinic visits, missed treatments or a history of mismanagement of diet or medications), as evaluated by the Investigator.
- Patient who has acute renal failure with the chance for recovery.
- Patient who is pre-scheduled for a living donor kidney transplant within the next 6 months.
- Patient who is not expected to live at least 6 months while maintaining PD treatment.
- Patient who had major abdominal surgery within 6 months prior to study enrollment.
- Patient with current abdominal hernia, as evaluated by the Investigator.
- Patient with advanced liver or pulmonary disease, as evaluated by the Investigator.
- Positive serology test for Hepatitis B Virus or Hepatitis C Virus infection, or aspartate transaminase or alanine aminotransferase \> 3 x upper limit of normal at Screening.
- Patient with diagnosed stage III or IV New York Heart Association (NYHA) heart failure.
- Patient who has an active malignancy.
- History of a clinically significant illness and/or clinically significant surgery within the past 14 days preceding the Screening Visit as determined by the Investigator.
- Patient who is enrolled in another interventional clinical study.
Key Trial Info
Start Date :
December 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03812679
Start Date
December 20 2018
End Date
February 19 2020
Last Update
July 14 2025
Active Locations (11)
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1
Investigational Site
Jonesboro, Arkansas, United States, 72401
2
Investigational Site
San Jose, California, United States, 95125
3
Investigational Site
Jacksonville, Florida, United States, 32224
4
Investigational Site
Chicago, Illinois, United States, 60612