The current standard for end-stage renal disease (ESRD) patients is a kidney transplant or dialysis when a kidney donor is unavailable. The global dialysis population is exponentially growing, with 3 million patients worldwide currently on hemodialysis. The need for kidney organ donors in the U.S. is predicted to grow 8% each year (from 2018).
Thus, there is an increased need for innovative technologies, specifically in the field of kidney replacement technology, to address organ shortages and reduce risks associated with dialysis and renal failure.
Key Points:
By 2040, chronic kidney disease (CKD) is set to become the fifth global cause of mortality.
Two of the most recent advancements in kidney replacement technology are the implantable bioartificial kidney and kidney regeneration technology.
Improved value in dialysis care can only happen through patient-centered, innovative kidney care.
Advances in Dialysis
End-stage renal disease (ESRD) is characterized as a disease with a high hospitalization and mortality rate. Hemodialysis remains the most broadly used treatment for ESRD, with kidney transplants being the only alternative to kidney replacement therapy (KRT).
Technical, economic, and regulatory challenges faced in renal dialysis technology innovation have resulted in a standstill over the last 50 years. To promote increased cooperation and encourage innovation, the Kidney Health Initiative developed an international roadmap for new approaches to renal replacement therapy.
Recent innovations in hemodialysis have focused on portability and total replacement, not just replacing the kidney’s filtration function (clearance). Several enterprises and organizations, including The Advancing American Kidney Health Initiative, The Kidney Health Initiative, and Kidney X: The Kidney Accelerator, are collaborating to develop innovative technologies that may transform the treatment of ESRD.
Advances in hemodialysis include:
Hemodiafiltration
Hemodiafiltration is a form of KRT that makes use of convection in tandem with diffusive clearance. In the process of hemodiafiltration, the small to middle-sized solutes are carried through the membrane pores by convection. Convection allows a higher clearance rate of larger solutes compared to hemodialysis. Despite the advantages of hemodiafiltration, it has yet to gain acceptability in the U.S. due to regulatory and cost issues.
Portable hemodialysis machines
Recently portable and compact machines have been developed to reduce the size of dialysis machines. These devices make it easier for kidney disease patients to perform dialysis at home, resulting in increased flexibility and freedom.
Wearable artificial kidney (WAK)
Wearable and portable dialysis systems (artificial kidneys) perform the same functions as dialysis. However, these systems are housed in smaller and less intrusive packages.
For hemodialysis patients, WAK devices integrate a dual-channel battery-operated pump for driving dialysate and blood together with dialysate regenerative technology.
For peritoneal dialysis, a model of WAK is commercialized as an automated wearable kidney device. This device recycles peritoneal dialysate through a system made up of urease enzymes. These enzymes convert urea to ammonia, with sorbents such as zirconium which absorbs the ammonia.
Sorbent devices in dialysis therapy
Sorbent devices work by direct retention or absorption of specific molecules. In recent years, there has been progress in developing biocompatible sorbents. Current sorbent particles can remove toxins and impurities from the dialysate during dialysis. Sorbents aid in the reuse and regeneration of dialysate fluids.
Prospective studies have examined adding sorbent cartridges to conventional hemodialysis to improve the quality of life and survival rate.
Bioartificial Kidney
Bio-engineering artificial kidneys has been a research and innovation topic for the last 30 years. The basics of the technology used to develop bioartificial kidneys are based on cell-based therapeutics, specifically the principle that damaged or dysfunctional cells in multiple disease states can be replaced.
Like a human kidney, the bioartificial kidney produces ultrafiltrate that undergoes processing, resulting in the reabsorption of water and electrolytes back into the bloodstream. Examples of bioartificial kidneys include:
- The implantable kidney (The Kidney Project).
- The renal assist device (RAD).
- The human nephron filter.
- The bioartificial renal epithelial cell system (BRECS).
New Technology for Kidney Transplants
Historically, kidney failure may be best treated by a kidney transplant from an organ donor. Unfortunately, donor kidneys are limited; thus, ESRD patients end up on dialysis, which affects their overall quality of life and mortality. Dialysis is limited and often linked with poor patient outcomes as it does not make up for the loss of a healthy kidney’s endocrine, metabolic, and reclamation functions.
Thus, over the last 20 years, innovations in renal replacement therapy have been working to create a product that will replace full renal functionality. Two early models of renal replacement technology are the automated WAK and the WAK. These two devices are still limited as they only focus on ultrafiltration and not full renal functionality.
The latest technologies transforming renal replacement are the implantable bioartificial kidney (BAK) and kidney regeneration technology, which addresses the limitation of the WAK and AWAK devices.
The implantable BAK is a free-standing, compact, surgically implanted device used to perform the majority of the biological kidney function in ESRD or kidney failure patients. The implantable BAK builds upon a Renal Assist Device (RAD), which is located outside the body. RAD is a bioartificial kidney that integrates a bioreceptor of human renal tubule cells and a membrane hemofilter to imitate a healthy kidney’s immunological, metabolic, and endocrine functions.
Kidney regeneration technology is the second innovation transforming the challenges faced in kidney care. Recent advancements in stem cell and developmental biology have resulted in the aim of creating a transplantable kidney craft constructed from a patient’s own cells.
The current method in kidney generation is scaffolding. Scaffolding is used for 3D structural support for specific cells and vasculature of the organ. Further research is needed to provide a roadmap for building kidney scaffolds necessary to facilitate organ functionality.
New Diagnostic Methods
New diagnostic methods would allow healthcare professionals to diagnose CKD earlier, as most patients are only diagnosed in stage 3. Novel diagnostic methods may be used to identify CKD in earlier stages.
- Imaging. Imaging techniques are non-invasive and can safely be repeated to evaluate changes in disease status. Advancements in imaging relate to overall kidney function, estimation of nephron numbers, fibrosis, and new functional MRIS and ultrasound techniques such as diffusion-weighted MRI.
- Biological fluid biomarkers. In nephrology, metabolomics and proteomics have been tested, in some cases being used as biomarkers or as tools used to identify individual biomarkers that are then further assessed. Furthermore, both DNA and RNA in biological fluids may also act as biomarkers. Biological fluid biomarkers should correspond with kidney disease, progression, early disease, and outcomes, allowing for non-invasive, rapid, and specific measurements.
Additional Advances in Kidney Disease Treatment
The main objective of these kidney disease treatments is to avoid dialysis care centers, prevent CKD progression, or treat CKD complications in advanced stages. Current advances in kidney disease treatment that have not already been discussed include the following:
Xenotransplantation
Xenotransplantation is an old concept of transplanting organs from animals such as pigs into humans. Due to the increased waiting list for kidney transplants, this concept has regained clinical and research attention. The field of biotechnology and CRISPR/Cas9 has allowed xenotransplantation across non-human species to have lower complications and higher success rates.
Medications
New drugs that have promising results in clinical trials and have recently been approved for the treatment of CKD complications, kidney protection, and specific causes of CKD include:
- Nonsteroidal MRA. This medication is used for kidney protection and has been shown to decrease hospitalization rates for strokes, Myocardial infarction, and heart failure. It may reduce CKD progression by reducing proteinuria.
- Endothelin receptor antagonists. This medicine may be used to decrease proteinuria and kidney disease progression in CKD patients with scleroderma.
- HIF stabilizers. These are oral agents used to treat CKD-associated anemia. Some HIF stabilizers are currently in clinical use in Japan and China, with the EMA recently approving roxadustat.
- Voclosporin. This drug is showing promising results in phase 3 clinical trials for patients with active lupus nephritis. So far, Voclosporin has provided better kidney outcomes, including urine protein to creatine ratio and eGRF.
Panoramic Health
Panoramic Health is a value-based kidney care platform led by physicians. Our priority is ensuring that our patients receive the care that they deserve, ultimately improving outcomes and quality of life.
Our Clinical Research Division is at the forefront of kidney care innovation, filling the gaps in clinical research so that our patients may have improved outcomes, enhanced quality of life, and slowed disease progression. We collaborate directly with the scientific community and partner with CROs and sponsors to bring long-term advancements to CKD treatment.
