A groundbreaking clinical trial has revealed the potential of a new drug, BI 690517, in treating chronic kidney disease.
This study, led by Dr. Katherine Tuttle at the University of Washington School of Medicine and executive director for research at Providence Inland Northwest Health in Spokane, showcases significant advancements in kidney disease treatment.
The trial’s findings, published today in The Lancet, focus on how BI 690517 can reduce albuminuria — a condition where albumin is present in the urine, indicating kidney damage.
Remarkably, 50% of participants in the trial experienced a significant reduction in albuminuria with BI 690517 alone. When combined with a standard-care medication, empagliflozin, this figure rose to 70%.
BI 690517 works by inhibiting the production of aldosterone, a hormone that helps regulate blood pressure but can accelerate kidney disease progression when present in excess.
The challenge with existing standard-care therapies, such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARB), is that they tend to increase aldosterone levels over time.
While aldosterone inhibitors can reduce organ inflammation and delay kidney failure, they also raise the risk of hyperkalemia (high blood potassium levels) and other side effects.
The trial, which ran from February 2022 to July 2023, involved 714 participants, all diagnosed with kidney disease. They were initially treated with empagliflozin or a placebo for eight weeks.
Following this, 586 participants received varying doses of BI 690517 or a placebo for 14 weeks. The 10 mg dose of BI 690517 showed the peak response in reducing albuminuria.
Although BI 690517 was associated with increased hyperkalemia rates, most cases did not require medical intervention.
Empagliflozin appeared to mitigate the risk of hyperkalemia, aligning with findings from meta-analyses involving nearly 50,000 participants.
These encouraging results are paving the way for a Phase 3 clinical trial led by Oxford Population Health in England. This upcoming trial aims to involve 11,000 patients worldwide, further exploring the drug’s efficacy.
Dr. Tuttle expressed optimism about the impact of these findings. With 75% of dialysis patients having diabetes or hypertensive kidney disease, effective treatment with agents like BI 690517 could potentially make dialysis almost obsolete.
This development represents a significant stride towards more effective and manageable treatments for chronic kidney disease, offering hope for many affected individuals.
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The research findings can be found in The Lancet.
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