Performance evaluation of the AMIA Automated Peritoneal Dialysis (APD) Solution Generation System in patients using the AMIA APD Cycler

About this Study

This research study is being done to determine if the AMIA Automated Peritoneal Dialysis (APD) Solution Generation System is safe and works to administer peritoneal dialysis to participants with end‐stage renal (kidney) disease.  The Consents have been amended to conform with protocol changes.

Sponsor Protocol ID:BXU011787
IRB Number:2019-0048
Closed for Enrollment
Interventional
Early Phase 1
January 23, 2020
Eligibility Criteria
18 years old
Both Male and Female
No
No
No

Inclusion CriteriaPatient is 18 years or older

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 CriteriaPatient 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 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.

Patient who has an active malignancy.

Patient who is enrolled in another interventional clinical study.

Categories Click category to view its trials.
Kidney/Renal Conditions
Participating Locations
University Physicians
Contact Information
Contact Name: Delia Owens
Phone Number: 601-815-9231
Email: dyowens@umc.edu
Principal Investigator:Divya Monga
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