Ozempic for chronic kidney disease: what the label and the FLOW trial report

A kidney indication on a diabetes drug

Ozempic is best known as a type 2 diabetes medicine, but its label has grown. Alongside glycemic control and a cardiovascular indication, it now lists a kidney indication. This guide explains who the label describes, what the FLOW trial measured, which results were individually significant and which were not, and what the label says about safety data from that trial. It is about published data and not a recommendation; kidney disease is managed by clinicians who know your results.

We read the Ozempic prescribing information, including section 1 and section 14.3, on 15 October 2026, together with the New England Journal of Medicine report of FLOW as indexed on PubMed and the ClinicalTrials.gov record. Our separate guide on GLP-1 medicines with kidney or liver impairment covers dosing cautions; this article is about the trial and the indication.

What the label says

• Indication: to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease. The label lists it alongside glycemic control in adults with type 2 diabetes and reduction of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.
• Trial dose: FLOW used Ozempic 1 mg once weekly.
• Evidence section: section 14.3 of the label describes FLOW as a randomized, double-blind, placebo-controlled, event-driven trial.

Who was in FLOW

According to the label, FLOW enrolled adults with type 2 diabetes and chronic kidney disease, defined as an eGFR of 25 to 75 mL/min/1.73m2 with a urine albumin-to-creatinine ratio (UACR) above 100 mg/g and below 5000 mg/g. Participants needed an HbA1c of 10% or lower at screening and had to be on standard background therapy, including the maximum tolerated labeled dose of an ACE inhibitor or angiotensin receptor blocker unless that was contraindicated or not tolerated. The trial excluded congenital or hereditary kidney disease such as polycystic kidney disease, and autoimmune kidney diseases including glomerulonephritis.

In total, 3,533 patients were randomized to Ozempic 1 mg weekly or placebo and followed for a median of 41 months. The mean age was 67 and 70% were male. At baseline the mean eGFR was 47 mL/min/1.73m2, 11% had an eGFR below 30, and the median UACR was 568 mg/g with 69% above 300 mg/g. Ninety-five percent were on an ACE inhibitor or angiotensin receptor blocker, 16% on an SGLT2 inhibitor, 76% on a statin and 50% on an antiplatelet agent.

The NEJM abstract adds that the trial was stopped early after a prespecified interim analysis, with a median follow-up of 3.4 years, and that it was funded by Novo Nordisk. The ClinicalTrials.gov record for NCT03819153 lists the study as completed with 3,533 enrolled.

What FLOW measured and found

The primary outcome was a composite: a sustained decline in eGFR of 50% or more, sustained eGFR below 15, chronic renal replacement therapy, renal death, or cardiovascular death. Sustained meant two consecutive measurements at least 28 days apart. The composite occurred in 331 of 1,767 patients (18.7%) on Ozempic and 410 of 1,766 (23.2%) on placebo, a hazard ratio of 0.76 (95% CI 0.66 to 0.88; p=0.0003). The label says the effect reflected a reduction in sustained eGFR decline of 50% or more, in progression to kidney failure, and in cardiovascular death.

Reading the table honestly

Not every row is a confirmed win. Sustained eGFR below 15, the need for chronic kidney replacement therapy and renal death each had confidence intervals that cross 1 in this table, and renal deaths were few (five in each group). The label itself notes there were few renal deaths. The composite, the 50% eGFR decline component, cardiovascular death, the cardiovascular composite and all-cause death have intervals that do not cross 1. The NEJM abstract also reports that the mean annual eGFR slope was less steep by 1.16 mL/min/1.73m2 on semaglutide.

The label also reports that the treatment effect on the primary composite was generally consistent across the prespecified subgroups examined, including age, sex, eGFR and UACR, but that the benefit was not evident in patients taking SGLT2 inhibitors at baseline, and that there were few events in those patients. Because only 16% of FLOW participants were on an SGLT2 inhibitor, the trial cannot say how Ozempic adds to that class. That is a question for a nephrologist or the prescriber managing your regimen.

Safety in the FLOW trial

The label states that in FLOW, safety data collection was limited to serious adverse events and selected predefined categories of adverse events regardless of seriousness, and that no new serious or severe adverse reactions were identified. The NEJM abstract reports serious adverse events in 49.6% of the semaglutide group and 53.8% of the placebo group. The general label warnings still apply to people with kidney disease. Our guides on dehydration and acute kidney injury, severe stomach problems and diabetic retinopathy walk through how the labels describe those. The limited safety collection is also a reason not to read FLOW as a full tolerability study.

How this fits with the other Ozempic and Wegovy indications

This indication is for adults with type 2 diabetes. The Wegovy label has its own list of indications, covered in our guides on cardiovascular risk reduction and the SELECT trial and MASH and the ESSENCE trial. Those are different populations and different medicines under different labels. Because insurers often review requests against the labeled indication, it matters which of the three Ozempic indications a prescriber is relying on; our guide on appealing a prior authorization denial explains how that vocabulary is used.

What FLOW does not tell you

• It does not cover people without type 2 diabetes. Enrollment required type 2 diabetes.
• It does not cover every kidney disease. Congenital, hereditary and autoimmune kidney diseases were excluded.
• It does not cover very advanced kidney disease. Enrollment started at an eGFR of 25, and 11% of participants were below 30.
• It does not tell you your own risk. The results are averages across a trial population that was on standard background therapy.
• It was sponsored by the manufacturer. The NEJM abstract lists Novo Nordisk as funder; that is common in registration trials, and it is worth knowing.

Questions to ask your care team

• Do my eGFR and urine albumin results fall in the range the label describes?
• How would this fit with my ACE inhibitor or angiotensin receptor blocker, and with any SGLT2 inhibitor?
• What kidney tests would we repeat, and how often?
• What should I do if I have vomiting or diarrhea and cannot keep fluids down?

Frequently asked questions

Does Ozempic have a kidney indication?

Yes, for adults with type 2 diabetes and chronic kidney disease: reduction of the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death.

How large was the FLOW effect?

The primary composite occurred in 18.7% versus 23.2%, a hazard ratio of 0.76 (95% CI 0.66 to 0.88).

Did Ozempic reduce the need for dialysis in FLOW?

Chronic renal replacement therapy occurred in 4.9% versus 5.7%, but the 95% confidence interval (0.63 to 1.12) included 1, so that component on its own was not shown to be reduced.

Was FLOW done in people without diabetes?

No. Participants had type 2 diabetes and chronic kidney disease.

Medical disclaimer. This article is informational, was prepared by the GLP-1.Reviews editorial team from the public sources listed above, and has not been reviewed by a physician. It is not medical advice. Label wording and regulator pages can change; confirm the instructions for your product with the Medication Guide that came with it. Talk to your prescriber or pharmacist about your own treatment, and see our medical disclaimer and editorial standards.

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