In vitro efficacy and safety of a system for sorbent-assisted peritoneal dialysis.
Maaike K van Gelder, Giulia Ligabue, Silvia Giovanella...
https://pubmed.ncbi.nlm.nih.gov/32475132Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06314503
Clinical Validation of a Continuous Flow Peritoneal Dialysis System With Dialysate Regeneration
Led by UMC Utrecht · Updated on 2025-07-18
12
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
U
UMC Utrecht
Lead Sponsor
H
Horizon 2020 - European Commission
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new peritoneal dialysis device called WEAKID for patients with end-stage kidney disease. This device offers continuous flow and regeneration of dialysis fluid inside the abdomen using sorbents to remove toxins. The study aims to assess the short-term safety of the WEAKID system in a small group of patients undergoing peritoneal dialysis with well-functioning catheters and no recent infections. Participants will receive six treatment sessions over two weeks using the WEAKID system. The first week involves treatments without the sorbent chamber for 4 to 8 hours per session, and the second week includes treatments with the sorbent chamber for the same durations. This setup allows researchers to evaluate the effects of continuous dialysate flow separately from the sorbents' toxin removal. Throughout the study, participants will collect urine and dialysate samples before and during treatment. Blood samples will be taken at multiple time points, and peritoneal membrane function will be tested before and after treatment weeks. Researchers will monitor safety by tracking device-related effects, vital signs, blood chemistry, abdominal pressure, patient tolerance, and changes in uremic symptoms over a total participation period of about four weeks per participant.
CONDITIONS
Brief Title
First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Treated with peritoneal dialysis for at least 3 months before enrollment
- Well-functioning peritoneal catheter with no replacement for at least one month before enrollment
- No peritoneal dialysis-related infection within 8 weeks before enrollment
- Previous or current use of Extraneal dialysis fluid without contraindications
- Able to understand and provide informed consent
- Willing and able to follow all study procedures and attend visits
You will not qualify if you...
- Unable to provide informed consent
- Unable to comply with study procedures
- Received renal replacement therapy other than conventional peritoneal dialysis within 8 weeks prior
- Participated in another intervention trial within 8 weeks or currently in one
- Peritoneal dialysis-related infection within 8 weeks prior to enrollment
- Peritoneal catheter dysfunction or mechanical issues within one month prior
- Never used Extraneal dialysis fluid or have contraindications such as allergies or intolerances
- Incompatible peritoneal dialysis connection to the device
- Hemoglobin less than 6.2 mmol/L within 8 weeks prior
- Hyperkalemia (potassium >6.0 mmol/L) or hyponatremia (sodium <130 mmol/L) in the 8 weeks prior
- Hypocalcemia or hypomagnesemia within 8 weeks prior
- Serious medical conditions affecting safety or study effectiveness
- Pregnant or breastfeeding females during study period
- Life expectancy less than 3 months
- Planned living donor kidney transplant within 3 months after enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants will undergo screening procedures to confirm eligibility, including assessments of peritoneal catheter function and absence of recent infections.
Treatment
Duration - 2 weeks
Participants receive six treatments with the WEAKID peritoneal dialysis system over two weeks. During the first week, treatments without sorbents occur for 4 to 8 hours during the daytime. During the second week, treatments with sorbents occur for 4 to 8 hours during the daytime. This gradual exposure allows assessment of safety and effectiveness of the device and sorbents.
6 treatment visits during 2 weeks
Follow-up
Duration - 2 weeks
Participants are monitored for safety and device performance for up to four weeks after starting the study. This includes assessments of vital signs, adverse events, blood tests, and device function.
Follow-up visits occur after treatment completion during the total 4-week study period
Trial Site Locations
Total: 3 locations
1
Università degli studi di Modena e Reggio Emilia (UNIMORE)
Modena, Modena, Italy, 41121
Not Yet Recruiting
2
University Medical Center Utrecht (UMCU)
Utrecht, Utrecht, Netherlands, 3584 CX
Actively Recruiting
3
Hospital Universario La Paz (SERMAS)
Madrid, Madrid, Spain, 28029
Not Yet Recruiting
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Research Team
K
Karin GF Gerritsen, MD. PhD
D
Dian P Bolhuis, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Evaluation of a system for sorbent-assisted peritoneal dialysis in a uremic pig model.
Maaike K van Gelder, Joost C de Vries, Frank Simonis...
https://pubmed.ncbi.nlm.nih.gov/33278069