Innovation

The quality of life of dialysis patients matters to us  – we challenge the existing standard of care of hemodialysis and peritoneal dialysis, modifying the dialysis fluid by adding Creatine. Research indicates that chronic dialysis patients suffer from depletion of creatine in different organs of their body (see Wallimann et al. 2017; and Post et al. 2019) and that Creatine supplementation increases overall health, quality of life and well being of these dialysis patients (see Wallimann et al. 2017 ), since Creatine

  • Protects blood cells against metabolic and oxidative stress and protects their cell membranes against mechanical stress during dialysis, thus counteracting the loss of red blood cells through hemolysis, leading to anemia
  • Lowers fatigue levels, improves memory and learning function, alleviates depressions
  • Enhances bone cell proliferation, differentiation and mineralization thus counteracting, osteoporosis, osteomalacia and ABD (adynamic bone disease (ABD = renal osteodystrophy), problems often encountered in hemodialysis patients
  • Improves muscle cell mass, muscle cell function, proliferation and differentiation and finally overall muscle cell performance (force generation), parameters highly relevant quality of life parameters for hemodialysis patients
  • Protects body cells and tissues, against oxidative stress, lipid peroxidation, advanced glycation end products
  • Reduces the incidence of dialysis‐associated muscle cramps
  • Infers cardio-vascular protection
  • Supports immune cells and the immune system

Studies reported a poorer quality of life (QoL) in patients with renal replacement therapy compared to those with other chronic diseases, including cancer. Dialysis techniques over the past decades have seen only incremental innovation with no significant increase in the QoL of end-stage renal disease (ESRD) patients.

The United States Congress identified innovation for improved quality of life as a clearly underserved need (Chronic Kidney Disease Improvement in Research and Treatment Act of 2019).

Significantly poor QoL (Quality of Life) suggests that the current renal replacement therapies are are inadequate and a consequence of chronic underinvestment as explained in the table below provided by the US National Institutes of Health (NIH).

Research Funding by Disease

Disease Prevalence (Millions) 2014 Budgeta) ($ Million) % of 2014 NIH Budget NIH Spending per Patient
HIV/AIDS 1.2b) 3677 12 3064 $
Cancer 14.0c) 7957 27 568 $
Heart disease 27.0d) 1645 5 61 $
Kidney disease 20.0e) 585 2 29 $

a) According to NIH at http://report.nih.gov/categorical_spending.aspx.

b) According to the Centers for Disease Control and Prevention (CDC) at http://www.cdc.gov/hiv/basics/statistics.html.

c) According to the American Cancer Society at http://www.cancer.org/cancer/cancerbasics/cancer-prevalence.

d) According to CDC at http://www.cdc.gov/nchs/fastats/heart-disease.htm.

e) According to CDC at http://www.cdc.gov/diabetes/pubs/pdf/kidney_factsheet.pdf.

Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4815960/.

Health-related QoL refers to the measure of a patient’s functioning, well-being, and general health perception in each of three domains: physical, psychological, and social. Along with survival and other types of clinical outcomes, patient QoL is an important indicator of the effectiveness of the medical care they receive. QoL of patients with end-stage renal disease is influenced by the disease itself and by the type of replacement therapy. Numerous studies have identified the effect of factors such as anemia, age, comorbidity, and depression on QoL.

As per report produced by the United States Renal Data System, five-year survival rates of ESRD patients on hemodialysis and peritoneal dialysis are around 40%–50%, which is comparable to survival rates for those suffering from digestive system cancer or myeloma. These survival rates are also significantly lower than the rates for several cancers, indicating a need and sense of urgency to change the status quo. Furthermore, it is crucial to consider other aspects that impact the life of ESRD patients.

At a more granular level, QoL encompasses various aspects that impact a kidney disease patient, such as physical function, body pain, general health, vitality, social function, emotional role, mental health, symptoms, quality of social interaction, cognitive function, social support and sleep.

03