Evidence map›Paper›PMID 35861630›Full record

Trial reportJournal of diabetes investigation2022

Effect of canagliflozin on the decline of estimated glomerular filtration rate in chronic kidney disease patients with type 2 diabetes mellitus: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase III study in Japan.

Takashi Wada, Kazumi Mori-Anai, Akiko Takahashi, Takahiro Matsui, Masaya Inagaki, Mitsutaka Iida, Ken Maruyama, Hidetaka Tsuda

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of diabetes investigation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03436693. Cited by 21 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 13 pooled it
2.9field-weighted citation impact, top 8% 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.

NCT03436693 phase3completed

A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy

Ran2018Enrolled308Registered outcomes5Posted comparisons5ConditionsDiabetic NephropathyArmsCanagliflozin, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 13 syntheses or guidelines pooled it, 24 citations in OpenAlex.

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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

8 authors at 2 institutions in 2 countries.

Takashi WadaDepartment of Nephrology and Laboratory Medicine, Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.
Kazumi Mori-AnaiIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.ORCID https://orcid.org/0000-0002-7353-4201
Akiko TakahashiIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Takahiro MatsuiIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Osaka, Japan.
Masaya InagakiIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Mitsutaka IidaQuality & Vigilance Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Ken MaruyamaIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Hidetaka TsudaIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Mitsubishi Group (Japan) · JPKanazawa University · JP

Funding

Mitsubishi Tanabe Pharma Corporation N/A
6 · The paper itself

Abstract

AIMS/

introductionThe Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial has shown the effects of canagliflozin on preventing clinically important kidney outcomes in patients with type 2 diabetes mellitus and chronic kidney disease; however, not many Japanese patients were included in the trial. The present study evaluated the efficacy and safety of canagliflozin in Japanese chronic kidney disease patients with type 2 diabetes mellitus. MATERIALS AND

methodsIn this multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase III study, chronic kidney disease patients with type 2 diabetes mellitus were randomly assigned to receive either 100 mg canagliflozin or a matching placebo once daily for 104 weeks. The primary efficacy end-point was the incidence of a 30% decline in estimated glomerular filtration rate.

resultsOverall, 308 patients were randomized to the canagliflozin (n = 154) and placebo (n = 154) groups. The incidence of a 30% decline in estimated glomerular filtration rate at week 104 was 18.2% and 29.5%, respectively, and the point estimate of the intergroup difference (placebo - canagliflozin) was 11.3% (95% confidence interval 1.2-21.5, P = 0.029), which was significant. The overall incidence of adverse events was similar in the two groups.

conclusionsThis study suggests that canagliflozin safely reduces the risk of end-stage renal disease in Japanese chronic kidney disease patients with type 2 diabetes mellitus.

Indexed as

Diabetes Mellitus, Type 2Renal Insufficiency, ChronicSodium-Glucose Transporter 2 InhibitorsCanagliflozinGlomerular Filtration RateHumansJapanCanagliflozinSodium-Glucose Transporter 2 InhibitorsCanagliflozinChronic kidney diseaseType 2 diabetes mellitus

Identifiers

PMID35861630
PMCPMC9720226
OpenAlexW4286491108

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

Registered trials

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 Socratic graph.