Evidence map›Paper›PMID 29481660›Full record

Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2018

JAK1/JAK2 inhibition by baricitinib in diabetic kidney disease: results from a Phase 2 randomized controlled clinical trial.

Katherine R Tuttle, Frank C Brosius, Sharon G Adler, Matthias Kretzler, Ravindra L Mehta, James A Tumlin, Yoshiya Tanaka, Masakazu Haneda, Jiajun Liu, Maria E Silk and 6 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 165 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
165citing papers in PubMed, 1 pooled it
10.2field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

165 citing papers in PubMed, 1 synthesis or guideline pooled it, 271 citations in OpenAlex.

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105 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

16 authors at 8 institutions in 2 countries.

Katherine R TuttleProvidence Health Care, Spokane, WA, USA.
Frank C BrosiusDepartment of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.
Sharon G AdlerDivision of Nephrology and Hypertension, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.
Matthias KretzlerDepartment of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.
Ravindra L MehtaDivision of Nephrology, University of California, San Diego, CA, USA.
James A TumlinUniversity of Tennessee College of Medicine, Chattanooga, TN, USA.
Yoshiya TanakaThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Masakazu HanedaDepartment of Medicine, Asahikawa Medical University, Asahikawa, Hokkaido, Japan.
Jiajun LiuEli Lilly and Company, Indianapolis, IN, USA.
Maria E SilkEli Lilly and Company, Indianapolis, IN, USA.
Tracy E CardilloEli Lilly and Company, Indianapolis, IN, USA.
Kevin L DuffinEli Lilly and Company, Indianapolis, IN, USA.
Joseph V HaasEli Lilly and Company, Indianapolis, IN, USA.
William L MaciasEli Lilly and Company, Indianapolis, IN, USA.
Fabio P NunesEli Lilly and Company, Indianapolis, IN, USA.
Jonathan M JanesEli Lilly and Company, Indianapolis, IN, USA.
Eli Lilly (United States) · USUniversity of Michigan–Ann Arbor · USAsahikawa Medical University · JPUCLA Medical Center · USUniversity of California, San Diego · USUniversity of Occupational and Environmental Health Japan · JPUniversity of Tennessee at Chattanooga · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Inflammation signaled by Janus kinases (JAKs) promotes progression of diabetic kidney disease (DKD). Baricitinib is an oral, reversible, selective inhibitor of JAK1 and JAK2. This study tested the efficacy of baricitinib versus placebo on albuminuria in adults with Type 2 diabetes at high risk for progressive DKD. Methods: In this Phase 2, double-blind, dose-ranging study, participants were randomized 1:1:1:1:1 to receive placebo or baricitinib (0.75 mg daily; 0.75 mg twice daily; 1.5 mg daily; or 4 mg daily), for 24 weeks followed by 4-8 weeks of washout. Results: Participants (N = 129) were 63±9.1 (mean±standard deviation) years of age, 27.1% (35/129) women and 11.6% (15/129) African-American race. Baseline hemoglobin A1c (HbA1c) was 7.3±1% and estimated glomerular filtration rate was 45.0±12.1 mL/min/1.73 m2 with first morning urine albumin-creatinine ratio (UACR) of 820 (407-1632) (median; interquartile range) mg/g. Baricitinib, 4 mg daily, decreased morning UACR by 41% at Week 24 compared with placebo (ratio to baseline 0.59, 95% confidence interval 0.38-0.93, P = 0.022). UACR was decreased at Weeks 12 and 24 and after 4-8 weeks of washout. Baricitinib 4 mg decreased inflammatory biomarkers over 24 weeks (urine C-X-C motif chemokine 10 and urine C-C motif ligand 2, plasma soluble tumor necrosis factor receptors 1 and 2, intercellular adhesion molecule 1 and serum amyloid A). The only adverse event rate that differed between groups was anemia at 32.0% (8/25) for baricitinib 4 mg daily versus 3.7% (1/27) for placebo. Conclusions: Baricitinib decreased albuminuria in participants with Type 2 diabetes and DKD. Further research is required to determine if baricitinib reduces DKD progression.

Indexed as

AlbuminuriaAzetidinesDiabetes Mellitus, Type 2Diabetic NephropathiesDouble-Blind MethodFemaleGene Expression Regulation, EnzymologicGlomerular Filtration RateHumansJanus Kinase 1Janus Kinase 2MaleMiddle AgedPrognosisProtein Kinase InhibitorsPurinesAzetidinesbaricitinibJAK1 protein, humanJAK2 protein, humanJanus Kinase 1Janus Kinase 2Protein Kinase InhibitorsPurinesPyrazolesSulfonamides

Identifiers

PMID29481660
PMCPMC6212720
OpenAlexW2790867818

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.