An apparent win for Novo Nordisk’s GLP-1 blockbuster Ozempic in chronic kidney disease (CKD) could herald a shift in how the condition has been treated for decades. But dialysis bigwig DaVita—whose future business could be on the line—is making its skepticism known.
Based on the inclusion criteria for CKD patients in Novo Nordisk’s FLOW trial, which stopped early this week after hitting pre-specified criteria for efficacy, DaVita believes there may only be “limited application” of the findings to the overall CKD population.
DaVita, which shares a significant chunk of the dialysis industry with its German rival Fresenius, admitted it’s “nearly impossible” to draw any conclusions from Novo’s study at this point, given that the detailed results are still under wraps.
Emboldened by Ozempic’s performance thus far, Novo on Wednesday said it would begin powering down FLOW on the advice of the study’s independent data monitoring committee. The company expects the trial to read out during the first half of 2024.
The study tested Novo’s Ozempic (injectable semaglutide) at the 1-mg dose against placebo as an add-on to standard of care in diabetes patients with CKD. Specifically, FLOW is designed to show whether Ozempic can stall progression of CKD and curb the risk of death from kidney failure and cardiovascular issues.
Dialysis—which helps the body remove extra fluid and waste from the blood when the kidneys are unable to—became a standard treatment for kidney failure back in the 1970s, according to the National Kidney Foundation. Kidney failure is usually triggered by other health problems that progressively harm the organs over time, with diabetes posing the greatest risk, the American Kidney Fund says on its website.
DaVita says it’s been “closely monitoring” the performance of GLP-1 drugs such as Ozempic in CKD. The company specifically wants to know whether the results from Novo’s FLOW trial show improvements over the known effects of another class of diabetes meds called SGLT2 inhibitors.
The trouble, as DaVita sees it, is that Novo’s patient inclusion parameters might have been too narrow. Patients enrolled in FLOW had to have both Type 2 diabetes and CKD, plus, they needed to have received treatment with standard kidney disease therapies such as ACE inhibitors. The trial subjects also needed to demonstrate a certain amount of proteinuria, or protein in the urine.
DaVita figures fewer than 10% of all current CKD patients would have this specific combination of factors. As such, more studies and research are needed to determine whether any findings from FLOW could benefit a CKD population beyond those included in the trial, the company said.
DaVita also took issue with the study’s five-pronged composite endpoint, which includes factors like whether patients need dialysis or a kidney transplant. Findings on any one or more of those measurements could have triggered FLOW’s early stop, DaVita said.
It would be a win for CKD patients if FLOW ultimately shows Ozempic can reduce cardiovascular mortality, DaVita added. Many more CKD patients die of cardiovascular disease than those who progress to kidney replacement therapy.
A Novo Nordisk spokesperson said the company is out to make a difference in the lives of people living with CKD by targeting the underlying cause of the disease. The disease affects more than 800 million people worldwide, according to Novo.
While it’s early days for Ozempic in CKD, some analysts figure the drug and other GLP-1s like it—which have been shown to have a dramatic effect on obesity and diabetes—could eventually siphon off patients from the dialysis pool, Reuters reported Thursday.
DaVita provides dialysis and administrative services in the U.S. through a web of more than 2,700 outpatient dialysis centers in 46 states, plus the District of Columbia, the company said in a securities filing earlier this year.
Worldwide, 10% of the population suffers from CKD, with the disease causing millions of deaths each year, the National Kidney Foundation says.
DaVita's stock has fallen some 18% since Novo announced its early trial stop on Tuesday.

https://www.reuters.com/business/healthcare-pharmaceuticals/davita-says-ozempics-early-success-kidney-trial-have-limited-application-2023-10-12/