Evidence map›Paper›PMID 24722445›Full record

Trial reportJournal of the American Society of Nephrology : JASN2014

The endothelin antagonist atrasentan lowers residual albuminuria in patients with type 2 diabetic nephropathy.

Dick de Zeeuw, Blai Coll, Dennis Andress, John J Brennan, Hui Tang, Mark Houser, Ricardo Correa-Rotter, Donald Kohan, Hiddo J Lambers Heerspink, Hirofumi Makino and 7 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American Society of Nephrology : JASN, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01424319 (Reducing Residual Albuminuria in Subjects With Diabetes & Nephropathy With Atrasentan - A Phase 2b, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Safety & Efficacy in Japanese Subjects), which is not on this map. Cited by 136 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
136citing papers in PubMed, 2 pooled it
17.2field-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.

NCT01424319 phase2completednot on this map

Reducing Residual Albuminuria in Subjects With Diabetes & Nephropathy With Atrasentan - A Phase 2b, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Safety & Efficacy in Japanese Subjects

TypeinterventionalSponsorAbbVie (prior sponsor, Abbott)Ran2011 to 2012Enrolled58ConditionsChronic Kidney Disease, Diabetic NephropathyArmsAtrasentan low dose group, Atrasentan high dose group, Atrasentan placebo group
3 · Its place in the literature

Who cites it

136 citing papers in PubMed, 2 syntheses or guidelines pooled it, 291 citations in OpenAlex.

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  14. C-C motif-ligand 2 inhibition with emapticap pegol (NOX-E36) in type 2 diabetic patients with albuminuria.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2017
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  18. Recommendations for pre-analytical urine sample handling to allow optimal assessment of albuminuria and proteinuria.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026
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76 more citing papers are in PubMed but not listed here.

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

17 authors at 11 institutions in 9 countries.

Dick de ZeeuwDepartment of Clinical Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; d.de.zeeuw@umcg.nl.
Blai CollRenal Clinical Development and.
Dennis AndressRenal Clinical Development and.
John J BrennanRenal Clinical Development and.
Hui TangData and Statistical Sciences, AbbVie, North Chicago, Illinois;
Mark HouserRenal Clinical Development and.
Ricardo Correa-RotterSalvador Zubiran National Medical Science and Nutrition Institute, Mexico City, Mexico;
Donald KohanDivision of Nephrology, University of Utah Health Sciences Center, Salt Lake City, Utah;
Hiddo J Lambers HeerspinkDepartment of Clinical Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands;
Hirofumi MakinoOkayama University Graduate School of Medicine, Okayama, Japan;
Vlado PerkovicGeorge Institute for Global Health, University of Sydney, Sydney, Australia;
Yili PritchettAstellas Global Pharma Development, Inc., Northbrook, Illinois;
Giuseppe RemuzziAzienda Ospedaliera Papa Giovanni XXIII and IRCCS-Instituto di Ricerche Farmacologiche Mario Negri, Bergamo, Italy;
Sheldon W TobeSunnybrook Health Sciences Center, Toronto, Ontario, Canada;
Robert TotoUniversity of Texas Southwestern Medical Center, Dallas, Texas;
Giancarlo VibertiKings' College London School of Medicine, London, United Kingdom; and.
Hans-Henrik ParvingDepartment of Medical Endocrinology, Rigshospitalet University Hospital of Copenhagen, Copenhagen, Denmark.
University of Groningen · NLAbbVie (United States) · USAstellas Pharma (United States) · USInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán · MXOkayama University · JPOspedale Papa Giovanni XXIII · ITRigshospitalet · DKSunnybrook Health Science Centre · CAThe University of Texas Southwestern Medical Center · USUniversity of Sydney · AUUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Despite optimal treatment, including renin-angiotensin system (RAS) inhibitors, patients with type 2 diabetic nephropathy have high cardiorenal morbidity and mortality related to residual albuminuria. We evaluated whether or not atrasentan, a selective endothelin A receptor antagonist, further reduces albuminuria when administered concomitantly with maximum tolerated labeled doses of RAS inhibitors. We enrolled 211 patients with type 2 diabetes, urine albumin/creatinine ratios of 300-3500 mg/g, and eGFRs of 30-75 ml/min per 1.73 m(2) in two identically designed, parallel, multinational, double-blind studies. Participants were randomized to placebo (n=50) or to 0.75 mg/d (n=78) or 1.25 mg/d (n=83) atrasentan for 12 weeks. Compared with placebo, 0.75 mg and 1.25 mg atrasentan reduced urine albumin/creatinine ratios by an average of 35% and 38% (95% confidence intervals of 24 to 45 and 28 to 47, respectively) and reduced albuminuria≥30% in 51% and 55% of participants, respectively. eGFR and office BP measurements did not change, whereas 24-hour systolic and diastolic BP, LDL cholesterol, and triglyceride levels decreased significantly in both treatment groups. Use of atrasentan was associated with a significant increase in weight and a reduction in hemoglobin, but rates of peripheral edema, heart failure, or other side effects did not differ between groups. However, more patients treated with 1.25 mg/d atrasentan discontinued due to adverse events. After stopping atrasentan for 30 days, measured parameters returned to pretreatment levels. In conclusion, atrasentan reduced albuminuria and improved BP and lipid spectrum with manageable fluid overload-related adverse events in patients with type 2 diabetic nephropathy receiving RAS inhibitors.

Indexed as

AgedAlbuminuriaAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsAtrasentanBlood PressureDiabetes Mellitus, Type 2Diabetic NephropathiesDouble-Blind MethodDrug Therapy, CombinationEndothelin-1FemaleHumansKidney Function TestsLipidsMaleAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsAtrasentanEndothelin-1LipidsPyrrolidines

Identifiers

PMID24722445
PMCPMC4005314
OpenAlexW2096179755

What OpenQuestion holds

Textmetadata
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.