Randomized Clinical Trial on the Effect of Bardoxolone Methyl on GFR in Diabetic Kidney Disease Patients (TSUBAKI Study)

KI Reports
Masaomi NangakuTadao Akizawa

Abstract

Bardoxolone methyl significantly increases estimated glomerular filtration rate (eGFR) in patients with chronic kidney disease (CKD). However, the phase 3 study, Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes Mellitus: the Occurrence of Renal Events (BEACON), was terminated prematurely because bardoxolone methyl increased the risk for early-onset fluid overload in patients with identifiable risk factors for heart failure (elevated baseline B-type natriuretic peptide levels >200 pg/ml and prior history of hospitalization for heart failure). The Phase 2 Study of Bardoxolone Methyl in Patients with Chronic Kidney Disease and Type 2 Diabetes (TSUBAKI) study aimed to determine if patients without risk factors can mitigate the risk for fluid overload and whether changes in eGFR with bardoxolone methyl reflect true increases in GFR. This phase 2, randomized, multicenter, double-blind, placebo-controlled study enrolled patients with type 2 diabetes and stage 3-4 CKD. Patients were randomized 1:1 to bardoxolone methyl (n = 41) or placebo (n = 41) (cohort G3), or 2:1 to bardoxolone methyl (n = 24) or placebo (n = 14) (cohort G4), administered orally once daily for 16 weeks using a dose-titration...Continue Reading

References

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Citations

Jul 17, 2020·International Journal of Molecular Sciences·Yoshio Sumida Japan Study Group Of Nafld Jsg-Nafld
Jul 1, 2020·Clinical and Experimental Nephrology·Hironori Kanda, Kengo Yamawaki
Oct 6, 2020·Frontiers in Physiology·Koji TakemuraReiko Inagi
Oct 18, 2020·Pharmaceuticals·Stephanie KourakisEmma Rybalka
Nov 21, 2020·Kidney Research and Clinical Practice·Kandai NozuKazumoto Iijima
Jan 6, 2021·Antioxidants·Melania Guerrero-HueJuan Antonio Moreno
Jan 15, 2021·Journal of Cerebral Blood Flow and Metabolism : Official Journal of the International Society of Cerebral Blood Flow and Metabolism·Takahiko ImaiHideaki Hara
Nov 21, 2020·Antioxidants·Dionysios V ChartoumpekisGerasimos P Sykiotis
Jan 30, 2021·Diabetes & Metabolism Journal·Tomotaka YamazakiMasaomi Nangaku
Oct 31, 2020·Clinical Kidney Journal·Beatriz Fernandez-FernandezAlberto Ortiz
Sep 29, 2020·Journal of Atherosclerosis and Thrombosis·Hideki Fujii
Mar 6, 2021·Orphanet Journal of Rare Diseases·Stephanie KourakisEmma Rybalka
Jul 31, 2021·Biomedicine & Pharmacotherapy = Biomédecine & Pharmacothérapie·Junmin WangGuang Ji
Aug 7, 2021·Antioxidants·Midori SakashitaReiko Inagi

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Methods Mentioned

BETA
blood
urine collection
X-ray
urine collections

Clinical Trials Mentioned

NCT02316821

Software Mentioned

BEACON
SAS

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