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

NCT06314503 | Recruiting DMC

• 2 other identifiers: 23-075_CORDIAL_FIHNL83843.000.23
• Study Type: interventional
• Target: 12
• Locations: 3 countries
• Sites: 3

Brief 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). 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

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Chronic Kidney Diseases

Keywords

Peritoneal Dialysis; First-in-human; Medical device

Outcome Measures

Primary Outcomes (10)

• 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

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

• Critical changes in blood pressure

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

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

• Critical changes in heart rate

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

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

• Critical changes in body temperature

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

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

• Critical changes in oxygen saturation

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

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

• Critical changes in plasma potassium

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

  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)

• Critical changes in plasma calcium

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

  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)

• Critical changes in plasma bicarbonate

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

  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)

• Critical changes in intra-abdominal dialysate volume

  Critical changes requiring intervention in intra-abdominal dialysate volume.

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

• Critical changes in intra-abdominal pressure

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

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

Secondary Outcomes (66)

• Adverse events (AEs) and device deficiencies (DDs)

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

• Number of WEAKID treatments

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

• Duration of WEAKID treatments

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

• Dialysate flow rates during WEAKID treatment

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

• Evolution of blood pressure

  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)

Other Outcomes (2)

• Baseline characteristics

  These will be assessed at baseline

• Peritoneal equilibrium tests

  This will be assessed once at baseline and once the week after the last WEAKID treatment week (four weeks in total per participant).

Study Arms (1)

WEAKID

EXPERIMENTAL

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

Device: WEAKID

Interventions

WEAKID DEVICE

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

Also known as: CORDIAL

WEAKID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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 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
• 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

Sponsors & Collaborators

• UMC Utrecht: lead
• Horizon 2020 - European Commission: collaborator
• Dutch Kidney Foundation: collaborator
• Health Holland: collaborator
• Nanodialysis Ltd: collaborator
• University of Modena and Reggio Emilia: collaborator
• Servicio Madrileno De Salud (SERMAS): collaborator
• PPI Healthcare Consulting Ltd: collaborator

Study Sites (3)

Università degli studi di Modena e Reggio Emilia (UNIMORE)

Modena, Modena, 41121, Italy

NOT YET RECRUITING

University Medical Center Utrecht (UMCU)

Utrecht, Utrecht, 3584 CX, Netherlands

RECRUITING

Hospital Universario La Paz (SERMAS)

Madrid, Madrid, 28029, Spain

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 32475132 BACKGROUND

• 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.

  PMID: 33278069 BACKGROUND

Related Links

• Website regarding project CORDIAL

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karin GF Gerritsen, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate professor

Model Details: This study has a first-in-human, prospective, open-label, non-randomized, three-center, single-arm design.

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: March 18, 2024
• Study Start: January 22, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The following data will be shared (under restrictions if seen fit by the Principal Investigator) upon request: * The raw data * The study protocol describing the methods and materials * The script to process the data * The scripts leading to tables and figures in the publication * A codebook with explanations on the variable names * A 'read\ me.txt' file with an overview of files included and their content and use. The time period will be determined on a case-by-case basis. A data sharing agreement outlining the terms of use for the receiving party will be drawn up before data is transferred.
• Access Criteria: Data will be shared upon request after approval from the PI. The access criteria will be determined on a case-by-case basis.

Locations

NL (1); ES (1); IT (1)