Tokyo, April 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061247) titled 'The effect of canagliflozin on renal function in elderly patients with type 2 diabetes who retained cardiac function (Sub-analysis of the Canonical Study)' on April 20.
Study Type:
Observational
Primary Sponsor:
Institute - Nara Medical University Hospital
Condition:
Condition - Elderly (65 years or older) patients with type 2 diabetes and HFpEF
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Using existing data from the Canonical Study, we will confirm whether the effects of canaglifrongin on anemia biomarkers and renal function markers in "elderly (65 years or older) type 2 diabetic patients with HFpEF" are consistent with those reported in large-scale clinical trials using other SGLT2i. We will also confirm whether changes in tubular biomarkers (urinary L-FABP and urinary NGAL) in the early stages of SGLT2i administration can be useful indicators for predicting the changes in renal function (eGFR) and renal anemia (Hb, Ht, etc.).
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 65
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Total study participants of the CANONICAL study (82 people)
42 patients in Canaglu group, 40 patients in standard treatment group
Key exclusion criteria - A person with missing data for all anemia markers related to renal anemia (Hb, Ht, RBC-count, MCV, MCH) and renal function markers (eGFR).
Target Size - 82
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 23 Day
Date of IRB - 2025 Year 10 Month 23 Day
Anticipated trial start date - 2026 Year 04 Month 30 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070088
Disclaimer: Curated by HT Syndication.
