Problem:
Despite being life-saving, existing dialysis techniques have major shortcomings. In conventional peritoneal dialysis (PD) and hemodialysis (HD) blood purification and water removal are inadequate: performance <10% (of healthy kidneys). This contributes to severe health problems (cardiovascular morbidity ~10-30x higher) and high mortality (15‐20% per year). Quality of life is poor. Due to inadequate removal of phosphate and potassium, patients need phosphate and potassium binding drugs. The daily pill burden is one of the highest reported in any chronic disease state (>25/day for 25% of the patients). A strict diet is required, potentially compromising the nutritional status.
PD has advantages over HD. Patients can perform PD at home instead of going to a center 3-4x/week. Although lower in performance, PD results in more stable toxin concentrations in contrast to the saw-tooth pattern in intermittent HD, which aggravates toxicity. Residual renal function, associated with a survival benefit, is better preserved with PD than with HD. PD is a blood free system using a relatively simple access to the abdomen, which is less complex than the HD vascular access. Costs for PD (~50k€/patient/year) are ~40% lower than those for in-center HD.
Still, PD is not popular. Drawbacks are: low blood purification low, time-consuming exchange procedures and high risk of peritonitis (infection). Patients switch to HD after median 3.7 years, because of recurrent peritonitis or deterioration of the peritoneal membrane, due to exposure to high dialysate glucose concentrations (generating osmotic gradient for fluid extraction).
Importance for society:
WEAKID offers a new treatment modality, expected to have significant medical and economic impact. Currently ~80% of patients are treated by HD in a center. Since WEAKID overcomes the main problems of PD, we expect WEAKID to enhance popularity of PD. The improved technique durability may cause a shift from in-center HD to home-based WEAKID therapy, at considerably reduced cost. Better blood purification is expected to improve health and well-being, allowing patients to stay active with social and economic quality of life.
Objectives:
WEAKID (Wearable Artificial Kidney) aims to clinically validate a new method for PD, prove patient acceptability and gain accreditation for the system to be used by patients. WEAKID is based on continuous flow PD using (currently standard) single lumen fluidic access (abdomen). Peritoneal dialysate is continuously circulated and refreshed by a wearable sorption unit, removing toxins from the dialysate. The technology has been demonstrated in preclinical research and is suited both for wearable dialysis (16 hours/day) and portable dialysis (8 hours/night). WEAKID enhances blood purification 2-3 fold with only one dialysate exchange per day (vs 4-6/day with standard PD), reducing peritonitis risk. High (toxic) dialysate glucose concentrations (conventional PD) are no longer required for fluid extraction, slowing down functional deterioration of the peritoneal membrane. Data are continuously logged to a remote monitoring webportal.
Objectives:
- Validating the WEAKID wearable/portable dialysis system in a clinical setting and preparing it for CE-marking.
- Demonstrating the clinical efficacy and safety of the system in an early feasibility first-in-human trial and a pilot crossover trial in PD patients.
