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

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

Interventions

DEVICE

WEAKID

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

Sponsors & Collaborators

• Horizon 2020 - European Commission

  collaborator OTHER

• Dutch Kidney Foundation

  collaborator OTHER

• Health Holland

  collaborator OTHER

• Nanodialysis Ltd

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• Servicio Madrileno De Salud (SERMAS)

  collaborator UNKNOWN

• PPI Healthcare Consulting Ltd

  collaborator UNKNOWN

• UMC Utrecht

  lead OTHER

Principal Investigators

• Karin GF Gerritsen, MD, PhD · UMC Utrecht

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-22

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Italy
• Netherlands
• Spain

Study Locations