10 Reasons for Optimism from Kidney Week 2023

Signals explores the frontiers of healthcare technology, one [space] at a time. Subscribe on Substack for more in-depth analysis and updates.

What if I told you there's a conference as big as HLTH, but dedicated to the latest advancements in kidney care? That's exactly what Kidney Week 2023 delivered: 12,000 optimists from across the global kidney community descended on Philadelphia to take part in the annual meeting of the minds.

Whether you were in Philly last week or not, it's impossible to cover every poster, plenary and panel. This summary focuses on updates from devices, drugs, and tech-enabled care delivery. Leave a comment below for your 5,000+ fellow explorers reading this recap to let us know what's on your mind.

Without further ado, here's my short list of news and research you should know about if you're in the kidney [space].

Devices

1. Diality announced its plans for a clinical trial to support a home use indication for its Moda-flx Home Hemodialysis System.

CEO Osman Khawar said "The planned execution of our home clinical study is a testament to our organization’s growth and readiness to support clinical and commercial expansion in 2024."

Context: In August, Diality announced it had raised an additional $28 million to continue development of its mobile hemodialysis system and support early enrollment for a clinical trial of the device.

2. Quanta Dialysis Technologies presented real-world evidence from its Home Run? study.

Of the thirty-two evaluable participants successfully completing the Home Run study, 93% decided to take advantage of the IDE extension to prolong use of the Quanta Dialysis System in their homes.

CMO Paul Komenda said "The evidence suggests that the device can easily be integrated into home settings for use across a variety of age groups and other demographics throughout the dialysis community."

Context: The Quanta Dialysis System has been approved for use in the United Kingdom for home hemodialysis since 2020. The Company submitted a FDA 510(k) for home clearance in September 2023.

3. Outset Medical, Inc. published a number of new clinical studies at Kidney Week this year:

A study performed in partnership with Stanford University School of Medicine shows quality of life and functional benefits of Tablo for home hemodialysis (HHD) patients. Preliminary results of patient-reported outcomes show favorable effects of Tablo-enabled HHD on markers of physical health and symptoms of insomnia.

Another study shows that Tablo is learnable and memorable after extended training decay periods— for professional and first-time home users alike. The training decay averaged 16 days for HCPs and 13 days for patient/care partner pairs.

A third study shows that implementation of a new dialysis service line using Tablo decreased hospital transfers and displacement of patients in rural Alaska.

4. Netherlands-based Nextkidney shared their Neokidney home hemodialysis device.

Neokidney aims to be the smallest and lightest HHD device ever made. It weighs about 10kg (22 lbs) and only needs ~5 liters of dialysis fluid per treatment due to its unique sorbent technology that regenerates dialysate.

Context: Nextkidney raised a $8.3M Series B earlier this year. Bonus points: Keen eyes might recognize a celebrity cameo from Qasim Butt, MD below.

Drugs

5. A team of NHS researchers from the UK aimed to investigate the benefits of SGLT2i in kidney transplant recipients.

Use of SGLT2s may lower risks for graft loss and adverse cardiac events in kidney transplant recipients. Its lead author, Dr. Anwar, said "To date, all major SGLT2 inhibitor studies have excluded kidney transplant patients. This study was the largest observational study demonstrating the benefits of SGLT2 inhibitors in patients with kidney transplants."

Context: Several trials have shown the effectiveness of SGLT2s in cardiovascular events and its nephroprotective effects among patients with native kidney disease, but little is known about the safety and efficacy of SGLT2s in the kidney transplant setting.

6. 阿斯利康 presented new results from their ZENITH-CKD Phase IIB trial, and were also published in The Lancet .

Context: The results support progress to Phase III, which aims to start in Q4 2023.

7. Boehringer Ingelheim presented new data from a phase 2 trial.

The presented results suggest "additive" and "clinically relevant" efficacy— at the highest dose tested, BI 690517 plus empagliflozin achieved a 39.5% reduction in albuminuria compared to empagliflozin plus placebo.

Up to 70% of patients on the combination achieved the threshold of a 30% or better reduction in UACR, which was a secondary endpoint in the study.

Context: The company said it now plans to start a phase 3 study (EASi-KIDNEY) early next year. PS - I'm still tracking BI's partnership with Healthy.io announced earlier this year. Anyone have an update there?

8. Travere Therapeutics and its partners presented additional data from two pivotal studies: the phase 3 PROTECT trial in IgAN and phase 3 DUPLEX trial in FSGS.

Travere's Chief Medical Officer Dr. Jula Inrig said “These data from PROTECT suggest that FILSPARI has the potential to significantly delay time to kidney failure, which based on recently published data is projected to be an additional eight years versus being treated with standard of care.”

The results were also published in The Lancet and NEJM, respectively.

Tech-Enabled Care

9. Innovative Renal Care and DeLorean Artificial Intelligence announced a partnership.

IRC will integrate DeLorean AI’s advanced Renal AI technology product into its existing healthcare platform. Delorean AI offers a portfolio of healthcare AI products. Medical AI and its submodule, Renal AI, support a broad range of clinical needs including ESRD, CKD, diabetes, cardiovascular disease, COPD, and mental health.

Context: IRC includes more than 230 dialysis centers in 25 states. Along with 7 health system partnerships and more than 400 affiliated nephrologists, we serve approximately 15,000 patients. Delorean closed its $7.5M Series A in September.

10. The Tribe Has Spoken: Meet the most exciting trends in kidney care, according to kidney care professionals.

Zach Cahill and the ASN team put together their annual poll of the most exciting trends in kidney care. Here's what 138 respondents from the kidney community had to say about the 8 trends identified by Zach and his team.

From Zach's LI post:

"I appreciated how Prabir Roy-Chaudhury and Brigitte Schiller, MD emphasized how docs can change their patients' lives tomorrow with vascular access and home dialysis. John Sedor inspired us to think beyond conventional KRT with the #artificialkidney but risky innovations like those won't see wide adoption if more nephrologists are not involved in clinical trials like Barbara Gillespie, MD, FASN talked about. Susanne B. Nicholas talked about how kidney care happens in a context where a person's health is significantly impacted by external factors. Finally, Katherine Tuttle discussed SGLT2s and how broad adoption can change people's lives."

That's it from me. Let us know what you think and what I missed in the comments below. Subscribe on Substack for more insights and analysis.