Evidence map›Paper›PMID 31170712›Full record

Trial reportCardiorenal medicine2019

Effects of Bardoxolone Methyl on Magnesium in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease.

Dana V Rizk, Arnold L Silva, Pablo E Pergola, Robert Toto, David G Warnock, Melanie P Chin, Angie Goldsberry, Megan O'Grady, Colin J Meyer, Peter A McCullough

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

Trial report in Cardiorenal medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 30% 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

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 7 citations in OpenAlex.

  1. Antioxidants for adults with chronic kidney disease.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Pooled it
  3. Article
  4. Current Landscape of NRF2 Biomarkers in Clinical Trials.Antioxidants (Basel, Switzerland) · 2020
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 1 country.

Dana V RizkDepartment of Medicine, Nephrology Division, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Arnold L SilvaBoise Kidney and Hypertension Institute, Meridian, Idaho, USA.
Pablo E PergolaRenal Associates PA, San Antonio, Texas, USA.
Robert TotoInternal Medicine and Clinical Science, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
David G WarnockDepartment of Medicine, Nephrology Division, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Melanie P ChinProduct Development, Reata Pharmaceuticals, Irving, Texas, USA.
Angie GoldsberryProduct Development, Reata Pharmaceuticals, Irving, Texas, USA.
Megan O'GradyProduct Development, Reata Pharmaceuticals, Irving, Texas, USA.
Colin J MeyerProduct Development, Reata Pharmaceuticals, Irving, Texas, USA.
Peter A McCulloughBaylor Heart and Vascular Institute, Baylor Jack and Jane Hamilton Heart and Vascular Hospital, The Heart Hospital, Baylor University Medical Center, Dallas, Texas, USA, peteramccullough@gmail.com.
Reata Pharmaceuticals (United States) · USUniversity of Alabama at Birmingham · USBaylor University Medical Center · USBoise Kidney & Hypertension Institute · USRenal Associates P. A. · USThe University of Texas Southwestern Medical Center · US

Funding

University of Alabama at Birmingham's Diabetes Research CenterP30DK079626 · NIDDK · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Kirk Michael Habegger · 2013 to 2026
$19.5M
NIDDK NIH HHS P30 DK079626
6 · The paper itself

Abstract

backgroundTreatment with bardoxolone methyl (Bard) in a multinational phase 3 trial, Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes (BEACON), resulted in increases in estimated glomerular filtration rate with concurrent reductions in serum magnesium. We analyzed data from several trials to characterize reductions in magnesium with Bard.

methodsBEACON randomized patients (n = 2,185) with type 2 diabetes (T2DM) and stage 4 chronic kidney disease (CKD) 1:1 to receive Bard (20 mg) or placebo once daily. In a separate open-label study, magnesium levels from 24-hour urine and sublingual epithelial cell samples were analyzed in patients with stage 3b-4 CKD and T2DM administered 20 mg Bard for 56 consecutive days.

resultsBEACON patients randomized to Bard experienced significant reductions in serum magnesium from baseline relative to patients randomized to placebo (-0.17 mEq/L, 95% CI -0.18 to -0.60 mEq/L; p < 0.001). A separate study showed intracellular and urinary magnesium levels were unchanged with Bard treatment.

conclusionsBard treatment results in significant decreases in serum magnesium that are not associated with changes in intracellular and urinary magnesium levels, indicating that magnesium decreases are not due to renal magnesium wasting or total body magnesium depletion. Importantly, the decreases in serum magnesium with Bard are not associated with adverse effects on QT interval.

Indexed as

AgedDiabetes Mellitus, Type 2Diabetic NephropathiesDouble-Blind MethodElectrocardiographyFemaleGlomerular Filtration RateHumansMagnesiumMaleMiddle AgedOleanolic AcidRenal Insufficiency, Chronicbardoxolone methylMagnesiumOleanolic AcidBardoxolone methylChronic kidney diseaseMagnesium

Identifiers

PMID31170712
PMCPMC6751480
OpenAlexW2969097857

What OpenQuestion holds

Textmetadata
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.