Kidney outcomes with incretin receptor agonists in chronic kidney disease — included and excluded studies
The included-studies table with extracted data, the exclusions with reasons, and the risk-of-bias judgements.
§3Included and excluded studies
Every study contributing to this review is listed below with the data extracted from it. The extraction table is published at the level of the individual outcome and study so that the synthesis can be checked without the reader having to retrieve each source.
§3.1Included studies
Table 4. Included studies with the characteristics extracted from each.
| Study | Design | Randomised | Duration | Anchor outcome as reported | Year |
|---|---|---|---|---|---|
| STRIDESemaglutide | Randomised, double-blind, placebo-controlled | 792 | 52 weeks | Estimated treatment ratio 1.13 (95 % CI 1.06 to 1.21) | 2025 |
| FLOWSemaglutide | Event-driven kidney outcome trial | 3,533 | Median 3.4 years | Hazard ratio 0.76 (95 % CI 0.66 to 0.88); annual eGFR slope difference 1.16 mL/min/1.73 m² per year | 2024 |
| STEP-HFpEF-DMSemaglutide | Randomised, double-blind, placebo-controlled | 616 | 52 weeks | Directionally consistent with STEP-HFpEF with a smaller weight effect, as expected in a population with diabetes | 2024 |
| STEP-2Semaglutide | Randomised, double-blind, placebo-controlled | 1,210 | 68 weeks | Mean change −9.6 % with semaglutide 2.4 mg versus −3.4 % with placebo; the effect is attenuated relative to STEP 1, which the Institute records as a consistent… | 2021 |
| AWARD-11Dulaglutide | Randomised, double-blind, active-controlled | 1,842 | 36 weeks | Dose-dependent additional glycaemic and weight effect at 3.0 mg and 4.5 mg | 2020 |
| REWINDDulaglutide | Event-driven cardiovascular outcome trial | 9,901 | Median 5.4 years | Hazard ratio 0.88 (95 % CI 0.79 to 0.99) | 2019 |
| AWARD-7Dulaglutide | Randomised, open-label, active-controlled | 576 | 52 weeks | Non-inferior glycaemic control with a smaller decline in eGFR than insulin glargine | 2018 |
| HARMONY-OUTCOMESDulaglutide | Event-driven cardiovascular outcome trial | 9,463 | Median 1.6 years | Hazard ratio 0.78 (95 % CI 0.68 to 0.90) | 2018 |
| SUSTAIN-7Semaglutide | Randomised, double-blind, active-controlled | 1,201 | 40 weeks | Difference −0.41 percentage points (95 % CI −0.57 to −0.25) for semaglutide 1.0 mg versus dulaglutide 1.5 mg | 2018 |
| SUSTAIN-1Semaglutide | Randomised, double-blind, placebo-controlled | 388 | 30 weeks | Reduction of 1.5 percentage points with 1.0 mg versus 0.0 with placebo | 2017 |
| SUSTAIN-6Semaglutide | Event-driven cardiovascular outcome trial | 3,297 | 104 weeks | Hazard ratio 0.74 (95 % CI 0.58 to 0.95); designed to exclude harm rather than to establish benefit | 2016 |
| AWARD-1Dulaglutide | Randomised, double-blind, active-controlled | 976 | 26 weeks | Superior to exenatide twice daily and to placebo | 2014 |
| AWARD-5Dulaglutide | Randomised, double-blind, active-controlled | 1,098 | 52 weeks | Superior to sitagliptin at both doses | 2014 |
| AWARD-6Dulaglutide | Randomised, open-label, active-controlled | 599 | 26 weeks | Non-inferior to liraglutide 1.8 mg | 2014 |
| 14 included studies. Each links to its structured abstract, which carries a field-by-field provenance table distinguishing extracted figures from Institute reconstructions. | |||||
Contributing participants across studies reporting a randomised total: 35,492. Studies for which the Institute does not hold a randomised total contribute to the qualitative synthesis and not to any pooled figure.
§3.2Excluded at full text, with reasons
Table 5. Reports excluded at full text, by reason. A review that reports an exclusion count without reasons cannot be checked against its own protocol.
| Reason for exclusion | Reports |
|---|---|
| Not a randomised comparison | 3 |
| Population outside the review question | 7 |
| Intervention outside the review question | 4 |
| Comparator not eligible | 2 |
| No eligible outcome reported | 5 |
| Duplicate report of an included study | 5 |
| Conference abstract without extractable data | 8 |
| Retracted or subject to an expression of concern | 6 |
| 29 reports excluded at full text in total. | |
§3.3Risk of bias across included studies
Table 6. Risk-of-bias judgement recorded for each included study on the review's anchor outcome.
| Study | Risk of bias | Inconsistency | Indirectness | Imprecision | Publication bias |
|---|---|---|---|---|---|
| STRIDE | Low | Some | Low | Low | Low |
| FLOW | Low | Low | Low | Low | Low |
| STEP-HFpEF-DM | Low | Low | Some | Low | Low |
| STEP-2 | Low | Low | Low | Low | Low |
| AWARD-11 | Low | Low | Low | Low | Low |
| REWIND | Low | Low | Low | Low | Low |
| AWARD-7 | Low | Some | Low | Low | Some |
| HARMONY-OUTCOMES | Some | Low | Low | Low | Low |
| SUSTAIN-7 | Low | Low | Low | Low | Low |
| SUSTAIN-1 | Low | Low | Low | Low | Low |
| SUSTAIN-6 | Low | Low | Low | Low | Low |
| AWARD-1 | Low | Low | Low | Low | Low |
| AWARD-5 | Low | Low | Low | Low | Low |
| AWARD-6 | Low | Low | Low | Low | Low |
| Judgements are the Institute's own and are recorded per outcome. A study may carry a different judgement in a different review that assesses a different outcome from it. | |||||
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.