Evidence map›Paper›PMID 29405626›Full record

ArticleDiabetes, obesity & metabolism2018

Rationale and protocol of the Study Of diabetic Nephropathy with AtRasentan (SONAR) trial: A clinical trial design novel to diabetic nephropathy.

Hiddo J L Heerspink, Dennis L Andress, George Bakris, John J Brennan, Ricardo Correa-Rotter, Jyotirmoy Dey, Fan Fan Hou, Dalane W Kitzman, Donald Kohan, Hirofumi Makino and 6 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Diabetes, obesity & metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01858532 (A Randomized, Multicountry, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects With Type 2 Diabetes and Nephropathy. SONAR), which is not on this map. Cited by 36 papers.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed
9.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT01858532 phase3terminatednot on this map

A Randomized, Multicountry, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects With Type 2 Diabetes and Nephropathy. SONAR: Study Of Diabetic Nephropathy With Atrasentan

TypeinterventionalSponsorAbbVieRan2013 to 2018Enrolled5,107ConditionsDiabetic NephropathyArmsAtrasentan, Placebo
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 88 citations in OpenAlex.

  1. Trial
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  8. Early Change in Albuminuria with Canagliflozin Predicts Kidney and Cardiovascular Outcomes: AJournal of the American Society of Nephrology : JASN · 2020 · on this map
    Trial
  9. 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 · 2020
    Trial
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  12. Selective endothelin A receptor antagonism in chronic kidney disease: improving clinical application.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Review
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  17. 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 · 2023
    Article
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  19. Chronic Kidney Disease: Strategies to Retard Progression.International journal of molecular sciences · 2021
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 12 institutions in 9 countries.

Hiddo J L HeerspinkDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.ORCID 0000-0002-3126-3730
Dennis L AndressPharma Development, AbbVie, North Chicago, Illinois.
George BakrisDepartment of Medicine, Section of Endocrinology, ASH Comprehensive Hypertension Center, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.
John J BrennanPharma Development, AbbVie, North Chicago, Illinois.
Ricardo Correa-RotterDepartment of Nephrology and Mineral Metabolism, National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City, Mexico.
Jyotirmoy DeyPharma Development, AbbVie, North Chicago, Illinois.
Fan Fan HouDivision of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China.
Dalane W KitzmanDepartment of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.
Donald KohanDivision of Nephrology, University of Utah Health Sciences Center, Salt Lake City, Utah.
Hirofumi MakinoDepartment of Nephrology, Rheumatology, Endocrinology and Metabolism, Okayama University, Okayama-Shi, Japan.
John McMurrayBHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.
Vlado PerkovicFaculty of Medicine, George Institute for Global Health, UNSW Sydney, Newtown, Australia.
Sheldon TobeDepartment of Medicine, Division of Nephrology, Sunnybrook Health Sciences Centre, University of Toronto and the Northern Ontario School of Medicine, Toronto, Canada.
Melissa WigdersonPharma Development, AbbVie, North Chicago, Illinois.
Hans-Henrik ParvingDepartment of Medical Endocrinology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Dick de ZeeuwDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
AbbVie (United States) · USUniversity Medical Center Groningen · NLInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán · MXNanfang Hospital · CNOkayama University · JPSunnybrook Health Science Centre · CAUniversity of Chicago · USUniversity of Copenhagen · DKUniversity of Glasgow · GBUniversity of Utah · USUNSW Sydney · AUWake Forest University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsIndividuals with diabetes and chronic kidney disease (CKD) are at high risk for renal events. Recent trials of novel treatments have been negative, possibly because of variability in response to treatment of the target risk factor. Atrasentan is a selective endothelin A receptor antagonist that reduces urinary albumin-to-creatinine ratio (UACR), with a large variability between patients. We are assessing its effect on renal outcomes in the Study Of diabetic Nephropathy with AtRasentan (SONAR; NCT01858532) with an enrichment design (>30% lowering of albuminuria) to select patients most likely to benefit. MATERIALS AND

methodsSONAR is a randomized, double-blind, placebo-controlled trial with approximately 3500 participants who have stage 2-4 CKD and macroalbuminuria and are receiving a maximum tolerated dose of a renin-angiotensin system inhibitor.

resultsAfter 6 weeks of exposure to atrasentan 0.75 mg once daily (enrichment period), participants with ≥30% UACR decrease and no tolerability issues (responders) were randomly assigned to placebo or atrasentan 0.75 mg/day. The responder group will be used for primary efficacy and safety analyses. Approximately 1000 participants with <30% UACR reduction (non-responders) were also randomized to placebo or atrasentan. The primary endpoint is a composite of a sustained doubling of serum creatinine or end-stage renal disease. The original power calculation indicated that a total of 425 primary renal events in the responder group provides 90% power to detect a 27% reduction in relative risk (alpha level of .05).

conclusionSONAR aims to determine whether atrasentan added to guideline-recommended therapies safely reduces the risk of CKD progression and delays the onset of end-stage renal disease in patients with type 2 diabetes and nephropathy. SONAR also aims to establish whether the enrichment of patients based on their initial "surrogate" response to atrasentan will deliver a trial design in accord with personalized treatment of diabetic kidney disease.

Indexed as

Precision MedicineAdultAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsAtrasentanDiabetes Mellitus, Type 2Diabetic NephropathiesDisease ProgressionDouble-Blind MethodDrug ResistanceDrug Therapy, CombinationEndothelin A Receptor AntagonistsFemaleHumansKidneyKidney Failure, ChronicAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsAtrasentanEndothelin A Receptor Antagonistsatrasentandiabetic kidney diseaseendothelin receptor antagonistpersonalized medicinerandomized controlled clinical trial

Identifiers

PMID29405626
PMCPMC5969254
OpenAlexW2793672077

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.