BridgeMD
Tests treatment safety and results for Renal Insufficiency, Chronic
Official title First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients
ClinicalTrials.gov ID: NCT06314503
What this study is testing
- What it's testing
- 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.
- Time commitment: about 2 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥18 years of age
- Treated with PD for at least 3 months prior to enrolment
- Well-functioning peritoneal catheter and no peritoneal catheter replacement for at least a month prior to enrolment
- No PD-related infection (exit-site infection, tunnel infection or peritonitis) less than 8 weeks prior to enrolment (counting from the day that the...
- Previous or current use of Extraneal® with no contra-indications
You likely can't join if
- Patients who are unable to provide informed consent
- Patients who are unable to comply with study procedures
- Patients who received renal replacement therapy other than conventional PD less than 8 weeks prior to enrolment
- Patients who participated in an intervention trial less than 8 weeks prior to enrolment or are currently participating in an intervention trial...
- Patients with a PD-related infection (exit-site infection, tunnel infection or peritonitis) less than 8 weeks prior to enrolment (counting from the...
- Patients with peritoneal catheter dysfunction or mechanical issues less than one month prior to enrolment
See the full eligibility criteria
- ≥18 years of age
- Treated with PD for at least 3 months prior to enrolment
- Well-functioning peritoneal catheter and no peritoneal catheter replacement for at least a month prior to enrolment
- No PD-related infection (exit-site infection, tunnel infection or peritonitis) less than 8 weeks prior to enrolment (counting from the day that the treatment has been finished).
- Previous or current use of Extraneal® with no contra-indications
- Capable of understanding the patient information sheet and informed consent form (ICF) and give informed consent
- Willing and able to comply with all study procedures and attend all study visits
- Patients who are unable to provide informed consent
- Patients who are unable to comply with study procedures
- Patients who received renal replacement therapy other than conventional PD less than 8 weeks prior to enrolment
- Patients who participated in an intervention trial less than 8 weeks prior to enrolment or are currently participating in an intervention trial. Patients in an observational study without any interventions or in...
- Patients with a PD-related infection (exit-site infection, tunnel infection or peritonitis) less than 8 weeks prior to enrolment (counting from the day that the treatment has been finished)
- Patients with peritoneal catheter dysfunction or mechanical issues less than one month prior to enrolment
- Patients who have never used Extraneal® dialysis fluid or have a contra-indication for Extraneal®: a known allergy to cornstarch or icodextrin; maltose or isomaltose intolerance; glycogen storage disease
- Patients with an incompatible PD connection to the device (e.g. Fresenius PD system)
- Patients with haemoglobin concentrations \< 6.2 mmol/L (\< 10 g/dL) less than 8 weeks prior to enrolment
- Patients with hyperkalemia (\> 6.0 mmol/L) or hyponatremia (\< 130 mmol/L) in the 8 weeks prior to enrolment
- Patients with hypocalcemia (plasma total calcium concentration corrected for albumin \<2.20 mmol/L or ionized calcium \<1.15 mmol/L) or hypomagnesemia (plasma magnesium concentration \<0.70 mmol/L) in the 8 weeks prior...
- Patients with any serious medical condition which in the opinion of the investigator, may adversely affect the safety of the participant and/or how well it works of the study
- Female patients who are either (planning to become) pregnant within the study period or breast feeding
- Patients with a life expectancy \<3 months
- Anticipated living donor kidney transplantation \<3 months
The study team makes the final eligibility decision.
Where it's taking place
- Modena, Modena, Italy
- Utrecht, Utrecht, Netherlands
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Modena, Modena, Italy; Utrecht, Utrecht, Netherlands; Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.