Performance Evaluation of the AMIA APD Solution Generation System in Patients End Stage Renal Disease (ESRD)

Inclusion Criteria

• •1. Patient is 18 years or older.
• •2. 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.
• •3. 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.
• •4. 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.
• •5. 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.
• •6. Patient is available and is willing to complete training on the AMIA APD Solution Generation System.
• •7. Patient and home environment are deemed suitable for treatment with the AMIA APD Solution Generation System, while in the home.
• •8. Home electrical and water assessments meet suitability criteria for the AMIA APD Solution Generation System.
• •9. The patient's home has suitable wireless connection or patient is willing to allow installation of suitable wireless connection.
• •10. 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.
• •11. 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.
• •12. 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).