Diabetes complications

Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes

N Engl J MedPublished Randomised controlled trial

Primary result · Major kidney disease eventsResult — go to the resultHazard ratio 0.76 95% CI 0.66–0.88

Authors' conclusion

Semaglutide reduced the risk of clinically important kidney outcomes and death from cardiovascular causes in patients with type 2 diabetes and chronic kidney disease.

Study context

Population
Patients with T2D and CKD (eGFR 50 to 75 ml/min/1.73 m² and urinary albumin-to-creatinine ratio >300 and <5000, or eGFR 25 to <50 ml/min/1.73 m² and urinary albumin-to-creatinine ratio >100 and <5000)randomized
Participants
3,533 patients
Comparison
Subcutaneous semaglutide 1.0 mg weekly vs placebo
  • Semaglutiden = 1,767
  • Placebon = 1,766reference
Primary endpoint
Major kidney disease events: composite of kidney failure onset (dialysis, transplantation or eGFR <15 ml/min/1.73 m²), ≥50% eGFR reduction from baseline, or death from kidney-related or cardiovascular causes
Follow-up
Median 3.4 years
Methodological detailsplacebo-controlled, prespecified interim analysis, Early trial cessation recommended at a prespecified interim analysis
  • Placebo-controlled
  • Prespecified interim analysis
  • Early trial cessation recommended at a prespecified interim analysis

Primary result

Major kidney disease events

Hazard ratio

0.76

95% CI 0.66–0.88

P = 0.0003

Events by treatment group

Semaglutide

331

events

Placebo

410

events

Semaglutidevs Placebo
HR 0.76 (95% CI 0.66–0.88); P = 0.0003

As reported in the abstract

Secondary outcomes

OutcomeHR (95% CI)P value
Composite of kidney-specific components of the primary outcome0.79 (0.66–0.94)
Death from cardiovascular causes0.71 (0.56–0.89)
Major cardiovascular events (confirmatory secondary)18% lower risk with semaglutide · tested hierarchically0.82 (0.68–0.98)P = 0.029
Death from any cause (confirmatory secondary)20% lower risk with semaglutide · tested hierarchically0.80 (0.67–0.95)P = 0.01
OutcomeDifference (ml per minute per 1.73 m²)P value
Mean annual eGFR slope (confirmatory secondary)Less steep (slower decrease) with semaglutide · tested hierarchically1.16P < 0.001

Safety

Serious adverse events

Original publication

Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. N Engl J Med. Published 24 May 2024. doi:10.1056/nejmoa2403347

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