Evidence map›Paper›PMID 26153128›Full record

Trial reportClinical journal of the American Society of Nephrology : CJASN2015

Predictors of Atrasentan-Associated Fluid Retention and Change in Albuminuria in Patients with Diabetic Nephropathy.

Donald E Kohan, Hiddo J Lambers Heerspink, Blai Coll, Dennis Andress, John J Brennan, Dalane W Kitzman, Ricardo Correa-Rotter, Hirofumi Makino, Vlado Perkovic, Fan Fan Hou and 5 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical journal of the American Society of Nephrology : CJASN, 2015. 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 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
4.0field-weighted citation impact, top 6% 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

24 citing papers in PubMed, 37 citations in OpenAlex.

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  11. Article
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  17. Article
  18. Novel therapies for diabetic kidney disease.Kidney international supplements · 2018
    Review
  19. Article
  20. Systematic Literature Review of DPP-4 Inhibitors in Patients with Type 2 Diabetes Mellitus and Renal Impairment.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2016
    Review
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

15 authors at 1 institution in 1 country.

Donald E KohanDue to the number of contributing authors, the affiliations are provided in the Supplemental Material. donald.kohan@hsc.utah.edu.
Hiddo J Lambers HeerspinkDue to the number of contributing authors, the affiliations are provided in the Supplemental Material.
Blai CollDue to the number of contributing authors, the affiliations are provided in the Supplemental Material.
Dennis AndressDue to the number of contributing authors, the affiliations are provided in the Supplemental Material.
John J BrennanDue to the number of contributing authors, the affiliations are provided in the Supplemental Material.
Dalane W KitzmanDue to the number of contributing authors, the affiliations are provided in the Supplemental Material.
Ricardo Correa-RotterDue to the number of contributing authors, the affiliations are provided in the Supplemental Material.
Hirofumi MakinoDue to the number of contributing authors, the affiliations are provided in the Supplemental Material.
Vlado PerkovicDue to the number of contributing authors, the affiliations are provided in the Supplemental Material.
Fan Fan HouDue to the number of contributing authors, the affiliations are provided in the Supplemental Material.
Giuseppe RemuzziDue to the number of contributing authors, the affiliations are provided in the Supplemental Material.
Sheldon W TobeDue to the number of contributing authors, the affiliations are provided in the Supplemental Material.
Robert TotoDue to the number of contributing authors, the affiliations are provided in the Supplemental Material.
Hans-Henrik ParvingDue to the number of contributing authors, the affiliations are provided in the Supplemental Material.
Dick de ZeeuwDue to the number of contributing authors, the affiliations are provided in the Supplemental Material.
University of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesEndothelin A receptor antagonists (ERAs) decrease residual albuminuria in patients with diabetic kidney disease; however, their clinical utility may be limited by fluid retention. Consequently, the primary objective of this study was to identify predictors for ERA-induced fluid retention among patients with type 2 diabetes and CKD. A secondary objective was to determine if the degree of fluid retention necessarily correlated with the magnitude of albuminuria reduction in those patients receiving ERAs. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A post hoc analysis was conducted of the phase IIb atrasentan trials assessing albuminuria reduction in 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) who were randomly assigned to receive placebo (n=50) or atrasentan 0.75 mg/d (n=78) or 1.25 mg/d (n=83) for 12 weeks. Changes in body weight and hemoglobin (Hb) after 2 weeks of treatment were used as surrogate markers of fluid retention.

resultsBaseline predictors of weight gain after 2 weeks of atrasentan treatment were higher atrasentan dose, lower eGFR, higher glycated hemoglobin, higher systolic BP, and lower homeostatic metabolic assessment product. Higher atrasentan dose and lower eGFR also predicted decreases in Hb. There were no changes in B-type natriuretic peptide. There was no correlation between reduction in albuminuria after 2 weeks of atrasentan treatment and changes in body weight or Hb.

conclusionsIn the Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With Atrasentan/JAPAN trials, atrasentan-associated fluid retention was more likely in patients with diabetes and nephropathy who had lower eGFR or received a higher dose of atrasentan. Finding that albuminuria reduction was not associated with changes in body weight and Hb suggests that the albuminuria-reducing efficacy of atrasentan is not impaired by fluid retention.

Indexed as

AgedAlbuminuriaAtrasentanBody FluidsCreatinineDiabetes Mellitus, Type 2Diabetic NephropathiesDouble-Blind MethodEndothelin Receptor AntagonistsFemaleGlomerular Filtration RateGlycated HemoglobinHumansMaleMiddle AgedNatriuretic Peptide, BrainAtrasentanCreatinineEndothelin Receptor AntagonistsGlycated HemoglobinNatriuretic Peptide, BrainPyrrolidinesalbuminuriaatrasentandiabetic nephropathy

Identifiers

PMID26153128
PMCPMC4559498
OpenAlexW2107550750

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.