Why were Semaglutide Trials for Kidney Disease Early Terminated?
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Why were Semaglutide Trials for Kidney Disease Early Terminated?
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Why were Semaglutide Trials for Kidney Disease Early Terminated?
“Early Termination? Semaglutide Trials for Kidney Disease Treatment Reaches Mid-term Criteria; Results to Be Revealed in 2024”
Recently, the Phase 3 clinical trials for the use of Semaglutide (a GLP-1 receptor agonist) in treating kidney damage and chronic kidney disease in type 2 diabetes patients, known as the FLOW trial, was terminated prematurely.
The decision to end this clinical trial ahead of schedule was based on the recommendation of the Data Monitoring Committee. This committee concluded that the mid-term analysis of the clinical trial met certain predefined criteria, warranting the early termination of the trial. The research results will be disclosed in 2024, and we await them with anticipation.
FLOW is a randomized, double-blind, parallel, multicountry, Phase 3b clinical trial. The study included patients with type 2 diabetes who had an estimated glomerular filtration rate (eGFR) between 50 and 75 ml/min/1.73 m2 and a urine albumin-to-creatinine ratio (UACR) between 300 and 5000 mg/g, or patients with eGFR between 25 and 50 ml/min/1.73 m2 and UACR between 100 and 5000 mg/kg.
All patients were randomly assigned to either the treatment group (Semaglutide 1.0 mg) or the control group (placebo), with concomitant renin-angiotensin-aldosterone system blockade (unless intolerant or contraindicated).
The primary endpoint of the study was the time it took for patients to experience their first kidney function failure (persistent eGFR <15 ml/min/1.73 m2 or initiation of chronic kidney replacement therapy), a continuous decline in eGFR of ≥50%, or death due to kidney or cardiovascular reasons.
The study enrolled a total of 3534 patients with an average age of 66.6 years (standard deviation of 9.0). Their baseline glycated hemoglobin (HbA1c) was 7.8% (standard deviation of 1.3), and the average duration of diabetes was 17.4 years (standard deviation of 9.3). The baseline eGFR was 47.0 ml/min/1.73 m2 (standard deviation of 15.2), and the median UACR was 568 mg/g (ranging from 2 to 11852). According to KDIGO guidelines, 68.2% of the patients had a very high risk of CKD progression.
The FLOW study aims to evaluate the impact of Semaglutide on kidney outcomes in patients with chronic kidney disease and type 2 diabetes. The study is expected to be completed by the end of 2024.
Why were Semaglutide Trials for Kidney Disease Early Terminated?
Reference:
[1] Rossing P, Baeres FMM, Bakris G, et al. The rationale, design, and baseline data of FLOW, a kidney outcomes trial with once-weekly semaglutide in people with type 2 diabetes and chronic kidney disease. Nephrol Dial Transplant. 2023 Aug 31;38(9):2041-2051. doi: 10.1093/ndt/gfad009. PMID: 36651820; PMCID: PMC10469096.
(source:internet, reference only)
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