Trial reportDiabetes, obesity & metabolism2018
Baseline characteristics and enrichment results from the SONAR trial.
Trial report in Diabetes, obesity & metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
18 citing papers in PubMed, 39 citations in OpenAlex.
- Trial
- Individual Atrasentan Exposure is Associated With Long-term Kidney and Heart Failure Outcomes in Patients With Type 2 Diabetes and Chronic Kidney Disease.Clinical pharmacology and therapeutics · 2021Trial
- Inter-individual variability in atrasentan exposure partly explains variability in kidney protection and fluid retention responses: A post hoc analysis of the SONAR trial.Diabetes, obesity & metabolism · 2021Trial
- The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial: baseline characteristics.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2020Trial
- Baseline characteristics and enrichment results from the SONAR trial.Diabetes, obesity & metabolism · 2018Trial
- Determining the optimal dose of atrasentan by evaluating the exposure-response relationships of albuminuria and bodyweight.Diabetes, obesity & metabolism · 2018Trial
- Efficacy and safety of zibotentan and dapagliflozin in patients with chronic kidney disease: study design and baseline characteristics of the ZENITH-CKD trial.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2024Article
- Insulin resistance, kidney outcomes and effects of the endothelin receptor antagonist atrasentan in patients with type 2 diabetes and chronic kidney disease.Cardiovascular diabetology · 2023Article
- Randomized, double-blind, placebo-controlled phase 3 study of bardoxolone methyl in patients with diabetic kidney disease: design and baseline characteristics of the AYAME study.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2023Article
- Endothelin receptors in renal interstitial cells do not contribute to the development of fibrosis during experimental kidney disease.Pflugers Archiv : European journal of physiology · 2021Article
- Glomerular Endothelial Cell Crosstalk With Podocytes in Diabetic Kidney Disease.Frontiers in medicine · 2021Review
- Omics research in diabetic kidney disease: new biomarker dimensions and new understandings?Journal of nephrology · 2020Review
- The Role of Endothelin and Endothelin Antagonists in Chronic Kidney Disease.Kidney diseases (Basel, Switzerland) · 2020Review
- The SONAR study-is there a future for endothelin receptor antagonists in diabetic kidney disease?Annals of translational medicine · 2019Article
- Implementing personalized medicine in diabetic kidney disease: Stakeholders' perspectives.Diabetes, obesity & metabolism · 2018Review
- New clinical trial designs for establishing drug efficacy and safety in a precision medicine era.Diabetes, obesity & metabolism · 2018Review
- Treating diabetic complications; from large randomized clinical trials to precision medicine.Diabetes, obesity & metabolism · 2018Review
- Rationale and protocol of the Study Of diabetic Nephropathy with AtRasentan (SONAR) trial: A clinical trial design novel to diabetic nephropathy.Diabetes, obesity & metabolism · 2018Article
Corrections and comments
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Authors and funding
16 authors at 12 institutions in 9 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimThe SONAR trial uses an enrichment design based on the individual response to the selective endothelin receptor antagonist atrasentan on efficacy (the degree of the individual response in the urinary albumin-to-creatinine ratio [UACR]) and safety/tolerability (signs of sodium retention and acute increases in serum creatinine) to assess the effects of this agent on major renal outcomes. The patient population and enrichment results are described here.
methodsPatients with type 2 diabetes with an estimated glomerular filtration rate (eGFR) within 25 to 75 mL/min/1.73 m
resultsBaseline characteristics were similar for atrasentan responders and non-responders. Upon entry to the study, median UACR was 802 mg/g in responders and 920 mg/g in non-responders. After 6 weeks of treatment with atrasentan, the UACR change in responders was -48.8% (95% CI, -49.8% to -47.9%) and in non-responders was -1.2% (95% CI, -6.4% to 3.9%). Changes in other renal risk markers were similar between responders and non-responders except for a marginally greater reduction in systolic blood pressure and eGFR in responders.
conclusionsThe enrichment period has successfully identified a population with a profound UACR reduction without clinical signs of sodium retention in whom a large atrasentan effect on clinically important renal outcomes is possible. The SONAR trial aims to establish whether atrasentan confers renal protection.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.