The DOI matches its Crossref record; 5 of the 5 references it cites were found in a registry or an index.
Atrasentan in Patients with IgA Nephropathy
Open accessAbstract
BACKGROUND: Patients with IgA nephropathy and severe proteinuria have a high lifetime risk of kidney failure. The efficacy and safety of the selective endothelin type A receptor antagonist atrasentan in reducing proteinuria in patients with IgA nephropathy are incompletely understood. METHODS: of body-surface area. Patients were randomly assigned to receive atrasentan (0.75 mg per day) or matched placebo for 132 weeks. The primary outcome, assessed at a prespecified interim analysis of data from the first 270 patients in the main stratum, was the change in the 24-hour urinary protein-to-creatinine ratio from baseline to week 36; the change was estimated with the use of a repeated-measures model. (An exploratory stratum of patients who were receiving a sodium-glucose cotransporter 2 inhibitor were included in a separate analysis.) Safety analyses were based on adverse events across the entire main stratum. RESULTS: A total of 340 patients were recruited into the main stratum. Among the first 270 patients in the main stratum (135 per trial group) who completed the week 36 visit, the geometric mean percentage change in the urinary protein-to-creatinine ratio relative to baseline was significantly greater with atrasentan (-38.1%) than with placebo (-3.1%), with a geometric mean between-group difference of -36.1 percentage points (95% confidence interval, -44.6 to -26.4; P<0.001). The percentage of patients with adverse events did not differ substantially between the two groups. Fluid retention was reported by 19 of 169 patients (11.2%) in the atrasentan group and in 14 of 170 (8.2%) in the placebo group but did not lead to discontinuation of the trial regimen. No apparent cases of cardiac failure or severe edema occurred. CONCLUSIONS: In this prespecified interim analysis, atrasentan resulted in a significant and clinically meaningful reduction in proteinuria as compared with placebo in patients with IgA nephropathy. (Funded by Novartis; ALIGN ClinicalTrials.gov number, NCT04573478.).
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Cites
A New Equation to Estimate Glomerular Filtration Rate
Levey, A. S., Stevens, L. A., Schmid, C. H., Zhang, Y. (., Castro, A. F., Feldman, H. I., Kusek, J. W., Eggers, P., Van Lente, F., Greene, T., et al. (2009) · Annals of Internal Medicine · doi:10.7326/0003-4819-150-9-200905050-00006 · Cited by 25,603
Dapagliflozin in Patients with Chronic Kidney Disease
Heerspink, H. J. L., Stefánsson, B. V., Correa-Rotter, R., Chertow, G. M., Greene, T., Hou, F.-F., Mann, J. F. E., McMurray, J. J. V., Lindberg, M., Rossing, P., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2024816 · Cited by 5,618
Self-citationEmpagliflozin in Patients with Chronic Kidney Disease
The EMPA-KIDNEY Collaborative Group (2023) · New England Journal of Medicine · doi:10.1056/nejmoa2204233 · Cited by 2,754
Wyatt, R. J., & Julian, B. A. (2013) · New England Journal of Medicine · doi:10.1056/nejmra1206793 · Cited by 1,222
Heerspink, H. J. L., Greene, T., Tighiouart, H., Gansevoort, R. T., Coresh, J., Simon, A. L., Chan, T. M., Hou, F. F., Lewis, J. B., Locatelli, F., et al. (2019) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(18)30314-0 · Cited by 397
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- Kim S-G, Vo N, Lee S-H, et al. Atrasentan for the treatment of IgA nephropathy: interim results of the AFFINITY study. Kidney Int Rep 2023;8:1902-1902 (https://www.kireports.org/article/S2468-0249(23)01207-X/fulltext). · DOI
- 10.1016/S0140-6736(19)30772-X · DOI
- Heerspink HJL, Jardine M, Kohan DE, et al. Study design and baseline characteristics of ALIGN, a randomized controlled study of atrasentan in patients with IgA nephropathy. Kidney Int Rep (in press) (https://www.kireports.org/article/S2468-0249(24)01962-4/fulltext).
- 10.1016/S0140-6736(23)00569-X · DOI
- 10.1016/S0140-6736(23)02302-4 · DOI
- 10.1016/S0140-6736(23)01554-4 · DOI
- 10.1681/ASN.2009060593 · DOI
- 10.1161/JAHA.116.003896 · DOI
- 10.2215/CJN.08600718 · DOI
Metadata
- Authors
- Heerspink, H. J. L., Jardine, M., Kohan, D. E., Lafayette, R. A., Levin, A., Liew, A., Zhang, H., Lodha, A., Gray, T., Wang, Y., Renfurm, R., & Barratt, J.
- Affiliations
- The University of Sydney (AU)
- Novartis (Switzerland) (CH)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2025-02-06
- Volume
- 392
- Issue
- 6
- Pages
- 544-554
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4403753361
- Cited by
- 142
- References
- 5
- Citations by year
- 2026: 79 · 2025: 56
- FWCI
- 37.11
- Type
- journal article
- Language
- en
- Open access
- green
- figshare.com
- Licence
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Bristol Research (University of Bristol) (publishedVersion)
- Figshare (submittedVersion, cc-by)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- Explore Bristol Research (submittedVersion)
- Funders
- Novartis
- Topics
- Health Sciences › Medicine › Nephrology › Renal Diseases and Glomerulopathies
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Health Sciences › Medicine › Transplantation › Renal Transplantation Outcomes and Treatments
- Keywords
- atrasentan, IgA nephropathy, proteinuria, urine protein-to-creatinine ratio, fluid retention, SGLT2 inhibitors, kidney failure risk
- MeSH terms
- Atrasentan, Adult, Creatinine, Double-Blind Method, Female, Glomerular Filtration Rate, Glomerulonephritis, IGA, Humans, Male, Middle Aged, Proteinuria, Treatment Outcome, Endothelin A Receptor Antagonists
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