Seven months after Travere Therapeutics’ flagship drug received accelerated FDA approval in a rare kidney disease, the molecule has fallen short of the key goal of its confirmatory test. It’s the small molecule’s second Phase 3 failure this year.

Kidney care company Strive Health announced last week that it is collaborating with primary care company Oak Street Health to serve Medicare members with stage 4 chronic kidney disease and end-stage kidney disease.

In a new agreement, Interwell Health will provide care to Humana Medicare Advantage HMO and PPO members with chronic kidney disease in 13 states. It will also serve patients with end-stage kidney disease across the country.

Physicians often diagnose patients with chronic kidney disease (CKD) too late in the process, when dialysis is the only option left. This isn’t negligence on the part of physicians — it’s simply a consequence of a fee-for-service (FFS) healthcare model that works against patients’ financial well-being and deemphasizes preventative care.

Home care company Signify Health announced Tuesday that it added an in-home kidney health evaluation to its platform. Based on the results of the evaluation, the company can refer patients to their primary care physician or a specialist if they’re in need of further treatment.

This lack of monitoring is a serious problem—both for patients and for the overall healthcare system. The data show that in a typical dialysis center, each patient will suffer an average of 1.7 access blockages per year.

The FDA approved GSK drug Jesduvroq for treating anemia in patients with chronic kidney disease. The once-daily pill is the first oral medicine to pass FDA muster in this indication, giving patients a more convenient alternative to injectable anemia therapies.

These two health care settings provided invaluable lessons: get ahead of the curve through collaboration with other doctors, better monitoring, early referrals, and education.

Aside from rallying for more patient-oriented reimbursement and removing the red tape involved so that providers can provide home-based dialysis care, medical device manufacturers must also offer a turnkey solution for home-based therapy that includes servicing the device in a door-to-door model.

Otsuka Pharmaceutical is ending its alliance with Akebia Therapeutics, a move that comes less than two months after the FDA rejected their partnered anemia drug, vadadustat, and asked for another clinical trial. Otsuka alleges unspecified breaches of the agreement by Akebia, and ending the alliance early could spare it from spending hundreds of millions of dollars more on the drug.

The FDA rejected Akebia Therapeutics drug vadadustat as a treatment for anemia caused by chronic kidney disease. According to the biotech, the agency cited safety concerns and asked for another clinical trial to show that the pill’s benefits outweigh its risks.

The new organization combining InterWell, Fresenius Health Partners and Cricket Health is valued at $2.4 billion with a total addressable market of $170 billion, more than $6 billion of medical costs under management, and over 100,000 covered lives, according to the combined company.

Medicare’s Comprehensive Kidney Care Contracting model spotlights the importance of proactive, coordinated kidney care. It’s critical for nephrology practices to start incorporating this patient-centric approach and consider more than just immediate kidney concerns.

The FDA told Reata that the clinical data do not show that the drug, bardoxolone, slows the progression of the loss of kidney function in patients who have the rare disease Alport syndrome. The regulatory decision follows an FDA advisory committee vote recommending against approval of the small molecule drug.

To combat challenges facing the industry, both policymakers and entrepreneurs have been working on complementary strategies to help primary care physicians, nephrologists and other care team members disrupt the status quo.

ProKidney is going public in a SPAC merger that infuses the biotech with $825 million for Phase 3 tests and manufacturing of its autologous cell therapy for chronic kidney disease. More than slowing the decline in organ function, ProKidney says its cell therapy offers the potential to reverse injury caused by the condition.

CSL Limited makes many of its therapies from donated plasma, which posed a challenge as pandemic lockdowns led to a steep drop in plasma collections. In acquiring Vifor Pharma, CSL not only diversifies, it also expands its presence in the fast-growing nephrology market.

Nephrology products company Vifor Pharma is shelling out about $252 million combined up front to acquire Sanifit Therapeutics and Inositec, developers of drugs for a blood vessel complication affecting some chronic kidney disease patients. Both biotechs are in clinical trials with their respective lead drug candidates.

Given the suboptimal outcomes with existing therapies to manage chronic kidney disease patients on dialysis, there is a substantial unmet need that additional treatment options could potentially address.

Chronic kidney disease patients who experience pruritus after dialysis can now get relief from the first FDA-approved treatment for the condition. Cara Therapeutics received the FDA’s green light for its injectable drug, Korsuva.

Ardelyx drug tenapanor was rejected by the FDA as a treatment for a complication experienced by chronic kidney disease patients. The regulatory decision came two weeks after the company received an FDA letter citing deficiencies in the drug application.

The FDA has approved Bayer’s Kerendia to treat chronic kidney disease in patients with type 2 diabetes. The drug is the first in its class, giving the pharma giant an alternative way to compete against medicines already marketed by AstraZeneca and Johnson & Johnson.

Monogram Health, a Tennessee-based startup that offers in-home care services for patients with chronic kidney disease raised $160 million in funding. The startup plans to use the funds to fuel its expansion across the U.S.

As the nation continues to reckon with disparities in health, we have a real opportunity to remove barriers to proper kidney care.

Vera Therapeutics licensed the drug candidate after analysis of earlier trials revealed its promise. Boosted by $80 million in Series C funding, the company hopes to launch a phase 2B trial this year.

AI models offer an early look into who might develop kidney disease, who would benefit from early intervention, and the risk of further complications without a change in course. However, it is worth taking a close look to ensure any bias or gaps are addressed.  

CVS Health’s new HemoCare device would open up the at-home market for hemodialysis, which uses an artificial kidney device to perform the procedure and has traditionally been difficult to provide outside of a clinical setting.

The executive order is focused on increasing the supply of kidneys available for transplants, improving prevention and treatment of chronic kidney disease and pushing the majority of dialysis patients to get their treatment through less-costly and more convenient home care.

Healthy.io’s urinalysis testing kit – dubbed Dip.io – uses disposable strips and cups in conjunction with a smartphone camera to read and interpret results.