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Comment
. 2021 Mar;99(3):768-770.
doi: 10.1016/j.kint.2020.12.006.

Importance of standardizing renal outcomes in clinical trials: illustration by recent sodium glucose cotransporter 2 inhibitor studies

Daniël H van Raalte  1 , Petter Bjornstad  2 , Hiddo J L Heerspink  3 , Frederik Persson  4 , David Z I Cherney  5
Affiliations
Comment

Importance of standardizing renal outcomes in clinical trials: illustration by recent sodium glucose cotransporter 2 inhibitor studies

Daniël H van Raalte et al. Kidney Int. 2021 Mar.
No abstract available

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Conflict of interest statement

Conflicts of interest:

DHVR has acted as a consultant and received honoraria from Boehringer Ingelheim and Lilly, Merck, Novo Nordisk, Sanofi and AstraZeneca and has received research operating funds from Boehringer Ingelheim-Lilly Diabetes Alliance, AstraZeneca and Novo Nordisk; all honoraria are paid to his employer (AUMC, location VUMC). Dr. Bjornstad reports grants, personal fees and non-financial support from AstraZeneca, personal fees from Bayer, personal fees from Bristol Meyer Squibb, grants and personal fees from Boehringer-Ingelheim, personal fees from Eli-Lilly, grants and personal fees from Novo Nordisk, personal fees and non-financial support from Sanofi, personal fees from XORT, grants and personal fees from Horizon Pharma, outside the submitted work; .HJLH is consultant for AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, Chinook, CSL Pharma, Gilead, Janssen, Merck, Mundi Pharma, Mitsubishi Tanabe, Novo Nordisk, and Retrophin. He received research support from Abbvie, AstraZeneca, Boehringer Ingelheim and Janssen. FP reports grants, personal fees and non-financial support from Astra Zeneca, grants, personal fees and non-financial support from Novo Nordisk, personal fees from Boehringer Ingelheim, grants and personal fees from Amgen, personal fees from Novartis, personal fees from MSD, personal fees from Sanofi, personal fees from Eli Lilly, personal fees from Bayer, outside the submitted work. D.Z.I.C has received honoraria from Boehringer Ingelheim-Lilly, Merck, AstraZeneca, Sanofi, Mitsubishi-Tanabe, Abbvie, Janssen, Bayer, Prometic, BMS, Maze and Novo-Nordisk and has received operational funding for clinical trials from Boehringer Ingelheim-Lilly, Merck, Janssen, Sanofi, AstraZeneca and Novo-Nordisk.

Figures

Figure 1.
Figure 1.
eGFR of slopes of the placebo arms in the major trials conducted with SGLT2 inhibitors in cardiovascular outcome studies and dedicated kidney outcome trials. Change over time was estimated from eGFR curves of published individual trials, since some numerical data were not available.
See this image and copyright information in PMC

Comment on

  • International consensus definitions of clinical trial outcomes for kidney failure: 2020.
    Levin A, Agarwal R, Herrington WG, Heerspink HL, Mann JFE, Shahinfar S, Tuttle KR, Donner JA, Jha V, Nangaku M, de Zeeuw D, Jardine MJ, Mahaffey KW, Thompson AM, Beaucage M, Chong K, Roberts GV, Sunwold D, Vorster H, Warren M, Damster S, Malik C, Perkovic V; participant authors of the International Society of Nephrology’s 1st International Consensus Meeting on Defining Kidney Failure in Clinical Trials. Levin A, et al. Kidney Int. 2020 Oct;98(4):849-859. doi: 10.1016/j.kint.2020.07.013. Kidney Int. 2020. PMID: 32998816

References

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