FLOW — structured trial abstract
FLOW — Semaglutide in chronic kidney disease and type 2 diabetes: event-driven kidney outcome trial
§1Structured abstract
§1.1Objective
To evaluate Semaglutide in chronic kidney disease in type 2 diabetes and type 2 diabetes mellitus, against the comparator specified in §2, with the primary endpoint stated below.
§1.2Design
- Design
- Randomised, double-blind, placebo-controlled, event-driven kidney outcome trial
- Masking
- Double-blind with independent endpoint adjudication
- Phase
- Phase 3
- Randomised participants
- 3,533
- Duration of the primary analysis period
- Median 3.4 years
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
Time to first occurrence of a composite kidney outcome: onset of persistent 50 % or greater reduction in eGFR, persistent eGFR below 15 mL/min/1.73 m², initiation of kidney replacement therapy, or death from kidney or cardiovascular causes
§1.4Principal result
Hazard ratio 0.76 (95 % CI 0.66 to 0.88); annual eGFR slope difference 1.16 mL/min/1.73 m² per year.[1]
Stopped early for efficacy on the recommendation of its independent data monitoring committee. The Institute records early stopping as a source of modest effect-size inflation and says so wherever the FLOW estimate is reproduced.
§1.5Provenance of this abstract
Table 1. Field-by-field provenance. The Institute records which fields are extracted from a source and which are its own reconstruction, so that a reader can tell the two apart without leaving the page.
| Field | Provenance | Note |
|---|---|---|
| Design, phase, duration, primary endpoint | Extracted | Reproduced from the published report or the registry record. |
| Randomised participants | Extracted | Reproduced as published. |
| Principal result | Extracted | Reproduced as published, with the confidence interval where the Institute holds it. |
| Centres, countries and baseline characteristics | Reconstructed | Derived by the Institute from the design class and the randomised total. Presented in §2 as an illustrative operational profile and marked as such. These figures are not published characteristics of this trial. |
| Certainty assessment | Institute judgement | The Institute’s own domain-by-domain assessment, with reasoning recorded against each domain in §4. |
| Registry identifier | Not held | The Institute does not reproduce a registry identifier it has not verified and never constructs one. Documents are referenced by the Institute’s own identifier. |
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Perkovic V, Tuttle KR, Rossing P, Mahaffey KW, Mann JFE, Bakris G, Baeres FMM, Idorn T, Bosch-Traberg H, Lausvig NL, Pratley R. Effects of semaglutide on chronic kidney disease in patients with type 2 diabetes. New England Journal of Medicine 2024;391(2):109–121. doi:10.1056/NEJMoa2403347 · PMID 38785209
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.