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AzTrials

Renal Insufficiency, ChronicCORDIALNCT06314503

First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients

A study testing WEAKID in people with Renal Insufficiency, Chronic and Kidney Failure, Chronic, run by UMC Utrecht at 3 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
WEAKID
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
3 sitesin 3 countries
Study dates
22 Jan 2024to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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

Who cannot join

  • 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 post-market surveillance do not need to be excluded.
  • 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
Show all 15Show fewer
  • 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 to enrolment
  • Patients with any serious medical condition which in the opinion of the investigator, may adversely affect the safety of the participant and/or effectiveness 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

Trial locations and contacts

3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Karin GF Gerritsen, MD. PhD contact

+31887557375

k.g.f.gerritsen@umcutrecht.nl

Dian P Bolhuis, MSc contact

+31887557375

d.p.bolhuis-3@umcutrecht.nl

3 sites in 3 countries

Italy1 site, 1 recruiting

  • Università degli studi di Modena e Reggio Emilia (UNIMORE)

    Modena, Modena, 41121

    Gabriele Donati, Prof., MD, PhD, +39-0594225331, gabriele.donati@unimore.it

    Giulia Ligabue, MSc, PhD, +39-0594224175, giulia.ligabue@unimore.it

    Not yet recruiting

Other trials in Italy

Netherlands1 site, 1 recruiting

  • University Medical Center Utrecht (UMCU)

    Utrecht, Utrecht, 3584 CX

    Karin GF Gerritsen, MD, PhD, +31-887557375, k.g.f.gerritsen@umcutrecht.nl

    Dian P Bolhuis, MSc, +31-887557375, d.p.bolhuis-3@umcutrecht.nl

    Recruiting

Other trials in Netherlands

Spain1 site, 1 recruiting

  • Hospital Universario La Paz (SERMAS)

    Madrid, Madrid, 28029

    Gloria del Peso Gilsanz, MD, PhD, +34-913585339, gloria.delpeso@salud.madrid.org

    Maria A Bajo Rubio, MD, PhD, +34-913585339, mauxiliadora.bajo@salud.madrid.org

    Not yet recruiting

Other trials in Spain

About this study

Official title: Clinical Validation of a Continuous Flow Peritoneal Dialysis System With Dialysate Regeneration

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.

Read more

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).

Read the detailed description

Peritoneal dialysis (PD) is a life-sustaining renal replacement therapy for patients with end-stage kidney disease (ESKD). With PD, waste solutes and excess water are drawn from the blood across the peritoneal membrane lining the abdominal cavity via diffusion and osmosis, respectively, into dialysis fluid (peritoneal dialysate) that is introduced into the abdominal cavity through a permanent tube (peritoneal catheter). The peritoneal dialysate is replaced 4-6 times/day either manually by the patient or automatically by a machine at night while the patient is asleep. PD is a gentle dialysis technique that provides continuous gradual dialysis while the patient is free to move during the day. However, PD has several disadvantages. Removal of waste solutes is inadequate and technique failure rate is high, contributing to poor quality of life and high (co)morbidity and mortality (10-15% per year). The low solute clearance (~1-7% of that of healthy kidneys (depending on the solute) and lower than that with haemodialysis (HD)) is due to rapid decrease of diffusive transport of solutes during a dwell due to the disappearance of the plasma-to-dialysate concentration gradient across the peritoneal membrane. The limited technique survival (median 3.7 years) is primarily due to the high incidence of recurrent infection of the peritoneal membrane (peritonitis) and exposure of the peritoneal membrane to very high, harmful glucose concentrations needed for osmotic fluid removal.

Both peritonitis and high glucose concentrations cause pathological changes of the peritoneal membrane and eventually ultrafiltration failure necessitating a switch to the more invasive and expensive HD treatment. To reduce the existing shortcomings of conventional PD, a novel continuous flow peritoneal dialysis system with dialysate regeneration (WEAKID) for PD was developed. WEAKID treatment is based on continuous recirculation of peritoneal dialysate via the single lumen peritoneal catheter with regeneration of spent dialysate by means of sorbent technology. The WEAKID nighttime system (weight: ~12 kg) is intended to be used for 8h per day (during the night) on a daily basis. Instead of performing 4-6 exchanges with fresh peritoneal dialysate per day, WEAKID uses one peritoneal dialysate filling which is continuously recirculated and regenerated. The continuous regeneration prevents saturation of the dialysate with toxins and thereby maintains a high plasma to dialysate concentration gradient which enhances diffusive transport of uremic toxins. In addition, the continuous recirculating flow of fluid along the peritoneal membrane is expected to increase the mass transfer area coefficient as observed in previous studies with continuous flow peritoneal dialysis, probably due to reduction of diffusion resistance, renewal of stagnant fluid layers at the tissue surface and an increase of the effective membrane area. Both the high plasma to dialysate concentration gradient and the increase in mass transfer contribute to an enhancement of the clearance. Another advantage of the WEAKID system is that the glucose peak load to peritoneum is lower than with traditional automated peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD) thanks to the buffering of the sorbents (sorbents adsorb glucose at the start, lowering the initial glucose peak, and release the glucose again at later stage) and the continuous recirculation.

The primary objective of this study is to assess the (short-term) safety of the WEAKID nighttime system in a limited number (n=12) of patients and sessions (6 sessions per patient).

Secondary objectives of this study are:

  1. To evaluate the incidence of adverse events (AEs) and device deficiencies (DDs) other than serious adverse device effects (SADEs) and DDs that could have led to a serious adverse event (SAE)
  2. To describe the characteristics of WEAKID treatment (i.e. number and duration of sessions, dialysate flow rates)
  3. To evaluate the clinical condition and vital signs of the participants during WEAKID treatment
  4. To evaluate the effectiveness of ultrafiltration (UF) in relation to glucose concentration during WEAKID treatment
  5. To evaluate the efficacy of solute removal and base release of WEAKID treatment
  6. To evaluate the evolution of plasma analytes during WEAKID treatment
  7. To evaluate the evolution of dialysate effluent analytes of the WEAKID system
  8. To evaluate the (technical) device performance of the WEAKID system by the number of device deficiencies, adverse device effects and changes in intraperitoneal pressure
  9. To evaluate patient tolerance during WEAKID treatment
  10. To evaluate the evolution of uremic symptoms during WEAKID treatment
  11. To evaluate the effectiveness of using sorbents for dialysate regeneration and the effectiveness of continuous recirculating flow in relation to the efficacy of solute removal.

The WEAKID system will be tested in a clinical setting on 6 days over a period of 2 weeks. During the first week, the subjects will be treated with the nighttime system without sorbents for 4h (first day) or 8h (second and third day) during daytime. The second week, treatment will consist of the nighttime system with sorbents (also 4h (first day) or 8h (second and third day) during daytime).

This way, exposure to new components of the system is incremental and the effectiveness of the sorbents can be analyzed separately from the effect of continuous recirculating flow dialysis. A peritoneal equilibration test (PET) will be performed at baseline and follow-up. In addition, patients will collect 24h spent peritoneal dialysate and 24h urine followed by venous puncture for blood sampling 3 times prior to WEAKID treatment during standard PD.

Being tested
WEAKID
Keywords
Peritoneal Dialysis, First-in-human, Medical device
Medical subject headings
Renal Insufficiency, Chronic, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WEAKIDDevice

    Also called CORDIAL

    Six treatments over the course of two weeks with the WEAKID system:

    • Week 1 (without the sorbents)
    • Day 1: four-hour treatment
    • Day 2: eight-hour treatment
    • Day 3: eight-hour treatment
    • Week 2 (with the sorbents)
    • Day 1: four-hour treatment
    • Day 2: eight-hour treatment
    • Day 3: eight-hour treatment
Study groups in NCT06314503
Study groupRoleWhat they receive
WEAKIDExperimentalSix treatments over the course of two weeks with the WEAKID system
Receives: Device: WEAKID

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serious adverse device effects (SADEs) and device deficiencies (DDs)

    Serious adverse device effects (SADEs) and device deficiencies (DDs) that could have led to a serious adverse event

    Measured: This will be assessed through study completion (four weeks in total per participant)

  2. Critical changes in blood pressure

    Critical changes requiring intervention in blood pressure (measured in mmHg; both systolic and diastolic pressures will be assessed).

    Measured: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  3. Critical changes in heart rate

    Critical changes requiring intervention in heart rate (measured in beats per minute).

    Measured: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  4. Critical changes in body temperature

    Critical changes requiring intervention in body temperature (measured in °C).

    Measured: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  5. Critical changes in oxygen saturation

    Critical changes requiring intervention in oxygen saturation (measured in %).

    Measured: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  6. Critical changes in plasma potassium

    Critical changes requiring intervention in plasma potassium (before and after WEAKID treatment in mmol/L).

    Measured: This will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  7. Critical changes in plasma calcium

    Critical changes requiring intervention in plasma calcium (before and after WEAKID treatment in mmol/L).

    Measured: This will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  8. Critical changes in plasma bicarbonate

    Critical changes requiring intervention in plasma bicarbonate (before and after WEAKID treatment in mmol/L).

    Measured: This will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  9. Critical changes in intra-abdominal dialysate volume

    Critical changes requiring intervention in intra-abdominal dialysate volume.

    Measured: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  10. Critical changes in intra-abdominal pressure

    Critical changes requiring intervention in intra-abdominal dialysate pressure (in mbar).

    Measured: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

Secondary outcomes (66)

  1. Adverse events (AEs) and device deficiencies (DDs)

    Assessing incidence of adverse events (AEs) and device deficiencies (DDs) other than SADEs and DDs that could have led to an serious adverse event (SAE).

    Measured: This will be assessed through study completion (four weeks in total per participant)

  2. Number of WEAKID treatments

    The number of WEAKID treatments per patient will be determined

    Measured: The number of WEAKID treatments will be assessed for the study treatment period (2 weeks in total per participant)

  3. Duration of WEAKID treatments

    Duration of each WEAKID treatment will be assessed (in minutes).

    Measured: This will be assessed for each WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  4. Dialysate flow rates during WEAKID treatment

    Dialysate flow rates will be determined during each WEAKID treatment (in mL/min).

    Measured: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  5. Evolution of blood pressure

    Blood pressure will be measured multiple times during a WEAKID treatment to examine its evolution during treatment (in mmHg).

    Measured: This will be assessed during WEAKID treatment at t=0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)

  6. Evolution of heart rate

    Heart rate will be measured multiple times during a WEAKID treatment to examine its evolution during treatment (in beats per minute).

    Measured: This will be assessed during WEAKID treatment at t=0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)

  7. Evolution of body temperature

    Body temperature will be measured multiple times during a WEAKID treatment to examine its evolution during treatment (in °C).

    Measured: This will be assessed during WEAKID treatment at t=0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)

  8. Evolution of oxygen saturation

    Oxygen saturation will be measured multiple times during a WEAKID treatment to examine its evolution during treatment (in %).

    Measured: This will be assessed during WEAKID treatment at t=0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)

  9. Ultrafiltration volume

    For each WEAKID session, ultrafiltration volume will be determined (in mL).

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  10. Peak glucose concentration in the device effluent

    For each WEAKID session, peak glucose concentration in the effluent of the device will be determined (in mmol/L).

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  11. Ultrafiltration efficiency

    For each session, ultrafiltration efficiency (volume of osmotic water removal per gram absorbed glucose) will be determined (in mL/gram absorbed glucose).

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  12. Removal of urea by the WEAKID system

    The removal of urea (in mmol) by the WEAKID system will be determined for each WEAKID treatment

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  13. Removal of creatinine by the WEAKID system

    The removal of creatinine (in mmol) by the WEAKID system will be determined for each WEAKID treatment

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  14. Removal of phosphate by the WEAKID system

    The removal of phosphate (in mmol) by the WEAKID system will be determined for each WEAKID treatment

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  15. Removal of potassium by the WEAKID system

    The removal of potassium (in mmol) by the WEAKID system will be determined for each WEAKID treatment

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  16. Removal of beta-2 microglobulin by the WEAKID system

    The removal of beta-2 microglobulin (in mmol) by the WEAKID system will be determined for each WEAKID treatment

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  17. Mass transfer area coefficient of urea

    The mass transfer area coefficient (MTAC) for urea will be determined for each WEAKID treatment (in mL/min)

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  18. Mass transfer area coefficient of creatinine

    The mass transfer area coefficient (MTAC) for creatinine will be determined for each WEAKID treatment (in mL/min)

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  19. Mass transfer area coefficient of phosphate

    The mass transfer area coefficient (MTAC) for phosphate will be determined for each WEAKID treatment (in mL/min)

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  20. Mass transfer area coefficient of potassium

    The mass transfer area coefficient (MTAC) for potassium will be determined for each WEAKID treatment (in mL/min)

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  21. Mass transfer area coefficient of beta-2 microglobulin

    The mass transfer area coefficient (MTAC) for beta-2 microglobulin will be determined for each WEAKID treatment (in mL/min)

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  22. Plasma clearance of urea

    The plasma clearance of urea will be determined for each WEAKID treatment (in mL/min)

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  23. Plasma clearance of creatinine

    The plasma clearance of creatinine will be determined for each WEAKID treatment (in mL/min)

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  24. Plasma clearance of phosphate

    The plasma clearance of phosphate will be determined for each WEAKID treatment (in mL/min)

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  25. Plasma clearance of potassium

    The plasma clearance of potassium will be determined for each WEAKID treatment (in mL/min)

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  26. Plasma clearance of beta-2 microglobulin

    The plasma clearance of beta-2 microglobulin will be determined for each WEAKID treatment (in mL/min)

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  27. The plasma reduction ratio of the protein-bound uremic toxin p-cresyl sulfate

    The plasma reduction ratio of p-cresyl sulfate will be calculated using the plasma concentrations before and after each WEAKID treatment.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  28. The plasma reduction ratio of the protein-bound uremic toxin p-cresyl glucuronide

    The plasma reduction ratio of p-cresyl glucuronide will be calculated using the plasma concentrations before and after WEAKID treatment.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  29. The plasma reduction ratio of the protein-bound uremic toxin indole acetic acid

    The plasma reduction ratio of indole acetic acid will be calculated using the plasma concentrations before and after WEAKID treatment.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  30. The plasma reduction ratio of the protein-bound uremic toxin kynurenine

    The plasma reduction ratio of kynurenine will be calculated using the plasma concentrations before and after WEAKID treatment.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  31. The plasma reduction ratio of the protein-bound uremic toxin kynurenic acid

    The plasma reduction ratio of kynurenic acid will be calculated using the plasma concentrations before and after WEAKID treatment.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  32. The plasma reduction ratio of the protein-bound uremic toxin hippuric acid

    The plasma reduction ratio of hippuric acid will be calculated using the plasma concentrations before and after WEAKID treatment.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  33. The release of base

    The release of base (in mmol) will be determined by calculating the sum of the release of bicarbonate (in mmol) and that of lactate (in mmol) for each WEAKID treatment

    Measured: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  34. Evolution of plasma levels of urea

    Urea plasma levels (in mmol/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  35. Evolution of plasma levels of creatinine

    Creatinine plasma levels (in micromol/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  36. Evolution of plasma levels of uric acid

    Uric acid plasma levels (in mmol/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  37. Evolution of plasma levels of beta-2 microglobulin

    Beta-2 microglobulin plasma levels (in mmol/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  38. Evolution of plasma levels of phosphate

    Phosphate plasma levels (in mmol/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  39. Evolution of plasma levels of potassium

    Potassium plasma levels (in mmol/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  40. Evolution of plasma levels of bicarbonate

    Bicarbonate plasma levels (in mmol/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  41. Evolution of plasma levels of lactate

    Lactate plasma levels (in mmol/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  42. Evolution of plasma levels of sodium

    Sodium plasma levels (in mmol/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  43. Evolution of plasma levels of chloride

    Chloride plasma levels (in mmol/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  44. Evolution of plasma levels of calcium

    Calcium plasma levels (in mmol/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  45. Evolution of plasma levels of magnesium

    Magnesium plasma levels (in mmol/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  46. Evolution of plasma levels of glucose

    Glucose plasma levels (in mmol/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  47. Evolution of plasma levels of lactate dehydrogenase

    Lactate dehydrogenase plasma levels (in U/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  48. Evolution of plasma levels of vitamin B12

    Vitamin B12 plasma levels (in mg/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  49. Evolution of plasma levels of albumin

    Albumin plasma levels (in g/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  50. Evolution of plasma leucocyte count

    Leucocyte count in plasma (in x10^9/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  51. Evolution of plasma thrombocyte count

    Thrombocyte count in plasma (in x10^9/L) will be determined before and after every WEAKID session.

    Measured: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

  52. Evolution of plasma levels of C-reactive protein (CRP)

    CRP plasma levels (in mg/L) will be determined before and after every series of three WEAKID sessions.

    Measured: This will be assessed before and after every series of three WEAKID treatment throughout the study treatment period (two times per week, two weeks in total per participant)

  53. Evolution of plasma levels of bilirubin

    Bilirubin plasma levels (in umol/L) will be determined before and after every series of three WEAKID sessions.

    Measured: This will be assessed before and after every series of three WEAKID treatment throughout the study treatment period (two times per week, two weeks in total per participant)

  54. Evolution of plasma levels of aspartate transaminase (ASAT)

    ASAT plasma levels (in U/L) will be determined before and after every series of three WEAKID sessions.

    Measured: This will be assessed before and after every series of three WEAKID treatment throughout the study treatment period (two times per week, two weeks in total per participant)

  55. Evolution of plasma levels of alanine aminotransferase (ALAT)

    ALAT plasma levels (in U/L) will be determined before and after every series of three WEAKID sessions.

    Measured: This will be assessed before and after every series of three WEAKID treatment throughout the study treatment period (two times per week, two weeks in total per participant)

  56. Evolution of sodium levels in dialysate effluent

    Sodium levels (in mmol/L) will be determined in dialysate effluent at various timepoints during every WEAKID treatment.

    Measured: This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)

  57. Evolution of chloride levels in dialysate effluent

    Chloride levels (in mmol/L) will be determined in dialysate effluent at various timepoints during every WEAKID treatment.

    Measured: This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)

  58. Evolution of calcium levels in dialysate effluent

    Calcium levels (in mmol/L) will be determined in dialysate effluent at various timepoints during every WEAKID treatment.

    Measured: This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)

  59. Evolution of magnesium levels in dialysate effluent

    Magnesium levels (in mmol/L) will be determined in dialysate effluent at various timepoints during every WEAKID treatment.

    Measured: This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)

  60. Evolution of bicarbonate levels in dialysate effluent

    Bicarbonate levels (in mmol/L) will be determined in dialysate effluent at various timepoints during every WEAKID treatment.

    Measured: This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)

  61. Evolution of lactate levels in dialysate effluent

    Lactate levels (in mmol/L) will be determined in dialysate effluent at various timepoints during every WEAKID treatment.

    Measured: This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)

  62. Evolution of pH of dialysate effluent

    pH of dialysate effluent will be determined at various timepoints during every WEAKID treatment.

    Measured: This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)

  63. Total number of device deficiencies and adverse device effects

    All device deficiencies (DDs) and adverse device effects (ADEs) will be reported and quantified.

    Measured: This will be assessed through study completion (four weeks in total per participant)

  64. Evolution of delta intraperitoneal pressure during WEAKID treatment

    Delta intraperitoneal pressure will be calculated using the following formula:

    intraperitoneal pressure during WEAKID treatment (in mbar) - intraperitoneal pressure at t=0 (in mbar). Intraperitoneal pressure is determined using the pressure sensors of the WEAKID device.

    Measured: This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)

  65. Patient tolerance (abdominal discomfort)

    Abdominal discomfort (scored using a numeric rating scale between 0-10) will be determined multiple times throughout the study period.

    Measured: This will be assessed at baseline, during every WEAKID treatment (at t = 0 minutes, 15 minutes, 1 hour, 2 hours, 4 hours, and 8 hours (for 8-hour treatment), and at the end of the study period (4 weeks in total per participant).

  66. Evolution of uremic symptoms

    Uremic symptoms will be scored using the Dialysis Symptom Index questionnaire; this is a questionnaire consisting of thirty yes/no questions regarding whether participants have experienced a certain symptom during the last week. If the answer is yes, the participant will score how much they have felt burdened by this specific symptom during the last week on a Likert scale from 0-4; the higher the score, the more burdened the participant felt.

    Measured: This will be assessed at baseline and on the day of the last WEAKID treatment of each treatment week (three times during three weeks in total per participant).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2024
  2. Study start22 Jan 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This study has a first-in-human, prospective, open-label, non-randomized, three-center, single-arm design.
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06314503
Sponsor's protocol ID
23-075_CORDIAL_FIH
Other IDs
NL83843.000.23
Acronym
CORDIAL
Status last verified
Jul 2025
First submitted
1 Jan 2024
Last updated
18 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Raw data will only be available to other researchers upon request and after approval of the Principal Investigator since the data is privacy-sensitive (pseudonymized) and commercially sensitive.

Publications

  • van Gelder MK, Ligabue G, Giovanella S, Bianchini E, Simonis F, Hazenbrink DHM, Joles JA, Bajo Rubio MA, Selgas R, Cappelli G, Gerritsen KGF. In vitro efficacy and safety of a system for sorbent-assisted peritoneal dialysis. Am J Physiol Renal Physiol. 2020 Aug 1;319(2):F162-F170. doi: 10.1152/ajprenal.00079.2020. Epub 2020 Jun 1.

    PubMed 32475132

  • van Gelder MK, de Vries JC, Simonis F, Monninkhof AS, Hazenbrink DHM, Ligabue G, Giovanella S, Joles JA, Verhaar MC, Bajo Rubio MA, Selgas R, Cappelli G, Gerritsen KGF. Evaluation of a system for sorbent-assisted peritoneal dialysis in a uremic pig model. Physiol Rep. 2020 Dec;8(23):e14593. doi: 10.14814/phy2.14593.

    PubMed 33278069

Questions about this trial

What is this clinical trial studying?

A study testing WEAKID in people with Renal Insufficiency, Chronic and Kidney Failure, Chronic, run by UMC Utrecht at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Karin GF Gerritsen, MD. PhD (+31887557375, k.g.f.gerritsen@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serious adverse device effects (SADEs) and device deficiencies (DDs) (time frame: This will be assessed through study completion (four weeks in total per participant)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06314503, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.

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