Actively Recruiting
First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients
Led by UMC Utrecht · Updated on 2025-07-18
12
Participants Needed
3
Research Sites
101 weeks
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
The goal of this first-in-human clinical trial is to examine the safety and efficacy of treatment with a new peritoneal dialysis (PD) device called WEAKID (WEarable Artificial KIDney for peritoneal dialysis). This device, unlike conventional PD, allows for continuous flow of dialysate inside the abdominal cavity combined with continuous regeneration of spent dialysate thanks to sorbents that remove toxins from the fluid. The study will include PD patients of 18 years or older with a well-functioning peritoneal catheter and no history of a PD-related infection for at least eight weeks prior to enrolment. The main purpose of this study is to assess the (short-term) safety of the WEAKID system in a limited number (n=12) of patients and sessions. Participants will undergo six treatment sessions (of four or eight hours) in total over a period of two weeks, either with or without a sorbent chamber. Participants will be asked to collect urine and dialysate the week before the first treatment and during the treatment days. In addition, blood samples will be collected before and during the treatment weeks in order to compare the effects of conventional PD with that of WEAKID treatment. A peritoneal equilibrium test will also be done before and after the treatment weeks to test the function of the lining of the abdomen (the peritoneal membrane).
CONDITIONS
Official Title
First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients
Who Can Participate
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 in the month before enrollment
- No peritoneal dialysis-related infection in the 8 weeks before enrollment
- Previous or current use of Extraneal® dialysis fluid with no contraindications
- Able to understand and provide informed consent
- Willing and able to comply with all study procedures and attend all 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 less than 8 weeks before enrollment
- Participated in an intervention trial less than 8 weeks before enrollment or currently participating in one
- Peritoneal dialysis-related infection less than 8 weeks before enrollment
- Peritoneal catheter dysfunction or mechanical issues less than one month before enrollment
- Never used Extraneal® dialysis fluid or have contraindications (allergy to cornstarch or icodextrin; maltose or isomaltose intolerance; glycogen storage disease)
- Incompatible peritoneal dialysis connection to the device
- Hemoglobin concentration less than 6.2 mmol/L (10 g/dL) less than 8 weeks before enrollment
- Hyperkalemia (> 6.0 mmol/L) or hyponatremia (< 130 mmol/L) in the 8 weeks before enrollment
- Hypocalcemia or hypomagnesemia in the 8 weeks before enrollment
- Any serious medical condition that may affect safety or study effectiveness
- Female patients who are pregnant, planning pregnancy, or breastfeeding during the study
- Life expectancy less than 3 months
- Planned living donor kidney transplant within 3 months
AI-Screening
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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
Research Team
K
Karin GF Gerritsen, MD. PhD
CONTACT
D
Dian P Bolhuis, MSc
CONTACT
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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