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Effect of Oral Methylprednisolone on Clinical Outcomes in Patients With IgA Nephropathy

2017· article· en· 530 citations· W2741457765 on OpenAlex· 10.1001/jama.2017.9362

Why is this work in the frame?

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

Canadian affiliationAn author listed a Canadian institution. This is the only route the usual frame has.
Canadian funderA Canadian agency funded it. The work may carry no Canadian affiliation at all.

Full frame distilled prediction

Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

Candidate categories
none
Consensus categories
none
Domain
Candidate signal: noneConsensus signal: none
Study design
Candidate signal: ObservationalConsensus signal: Observational
Genre
Candidate signal: EmpiricalConsensus signal: Empirical
Teacher disagreement score
0.065
Threshold uncertainty score
0.284
Validation status
machine_predicted_unvalidated · codex-gemma-dda1882f352a

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0000.001
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Opus teacher head0.018
GPT teacher head0.349
Teacher spread
0.331 · how far apart the two teachers sit on this one work
Validation status
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Abstract

Importance: Guidelines recommend corticosteroids in patients with IgA nephropathy and persistent proteinuria, but the effects remain uncertain. Objective: To evaluate the efficacy and safety of corticosteroids in patients with IgA nephropathy at risk of progression. Design, Setting, and Participants: The Therapeutic Evaluation of Steroids in IgA Nephropathy Global (TESTING) study was a multicenter, double-blind, randomized clinical trial designed to recruit 750 participants with IgA nephropathy (proteinuria greater than 1 g/d and estimated glomerular filtration rate [eGFR] of 20 to 120 mL/min/1.73 m2 after at least 3 months of blood pressure control with renin-angiotensin system blockade] and to provide follow-up until 335 primary outcomes occurred. Interventions: Patients were randomized 1:1 to oral methylprednisolone (0.6-0.8 mg/kg/d; maximum, 48 mg/d) (n = 136) or matching placebo (n = 126) for 2 months, with subsequent weaning over 4 to 6 months. Main Outcomes and Measures: The primary composite outcome was end-stage kidney disease, death due to kidney failure, or a 40% decrease in eGFR. Predefined safety outcomes were serious infection, new diabetes, gastrointestinal hemorrhage, fracture/osteonecrosis, and cardiovascular events. The mean required follow-up was estimated to be 5 years. Results: After randomization of 262 participants (mean age, 38.6 [SD, 11.1] years; 96 [37%] women; eGFR, 59.4 mL/min/1.73 m2; urine protein excretion, 2.40 g/d) and 2.1 years' median follow-up, recruitment was discontinued because of excess serious adverse events. Serious events occurred in 20 participants (14.7%) in the methylprednisolone group vs 4 (3.2%) in the placebo group (P = .001; risk difference, 11.5% [95% CI, 4.8%-18.2%]), mostly due to excess serious infections (11 [8.1%] vs 0; risk difference, 8.1% [95% CI, 3.5%-13.9%]; P < .001), including 2 deaths. The primary renal outcome occurred in 8 participants (5.9%) in the methylprednisolone group vs 20 (15.9%) in the placebo group (hazard ratio, 0.37 [95% CI, 0.17-0.85]; risk difference, 10.0% [95% CI, 2.5%-17.9%]; P = .02). Conclusions and Relevance: Among patients with IgA nephropathy and proteinuria of 1 g/d or greater, oral methylprednisolone was associated with an increased risk of serious adverse events, primarily infections. Although the results were consistent with potential renal benefit, definitive conclusions about treatment benefit cannot be made, owing to early termination of the trial. Trial Registration: clinicaltrials.gov Identifier: NCT01560052.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

The record

Venue
JAMA
Topic
Renal Diseases and Glomerulopathies
Field
Medicine
Canadian institutions
University Health NetworkUniversity of British ColumbiaHealth Sciences CentreSunnybrook Health Science Centre
Funders
Renmin Hospital of Wuhan UniversityShengjing HospitalWest China Hospital, Sichuan UniversityCanadian Institutes of Health ResearchPfizer PharmaceuticalsTongji UniversityGenentechFirst Affiliated Hospital of Zhengzhou UniversityGeorge Institute for Global HealthRenji HospitalHebei Medical UniversityBaotou Medical CollegeTongji Medical College, Huazhong University of Science and TechnologyNational Health and Medical Research CouncilNanjing UniversityPeking UniversityMedical Research CouncilZhejiang UniversitySchool of Medicine, Indiana UniversityRelypsaWuhan UniversityHenan UniversityRuijin HospitalUniversity of LeicesterNanjing General Hospital of Nanjing Military CommandZhengzhou UniversityFresenius Medical Care North AmericaUniversity of British ColumbiaEli Lilly and CompanyPfizerCharles Darwin UniversityDiabetes AustraliaHuazhong University of Science and TechnologyJanssen Research and DevelopmentAkebia TherapeuticsDiabetes Australia Research TrustChina Medical UniversitySanofiHenan University of Science and TechnologyHuashan HospitalRebecca L. Cooper Medical Research FoundationOmeros CorporationDavid Geffen School of Medicine, University of California, Los AngelesPeking University People's HospitalNational Institute of Diabetes and Digestive and Kidney DiseasesPostgraduate Institute of Medical Education and Research, ChandigarhQilu Hospital of Shandong UniversitySichuan UniversityShandong UniversityJohns Hopkins UniversityChugai PharmaceuticalGeneral Hospital of People’s Liberation ArmyMenzies School of Health ResearchShanxi Medical UniversityAmgenFudan UniversityPeking University First Hospital
Keywords
MedicineNephropathyRenal functionProteinuriaInternal medicineKidney diseaseGastroenterologyRandomized controlled trialMethylprednisoloneUrologyDiabetes mellitusKidneyEndocrinology
Has abstract in OpenAlex
yes