Actively Recruiting
Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD)
Led by Shinshu University · Updated on 2022-07-22
120
Participants Needed
1
Research Sites
266 weeks
Total Duration
On this page
Sponsors
S
Shinshu University
Lead Sponsor
K
Kowa Company, Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This multicenter, randomized, open-label, controlled study will assess the efficacy of the SGLT2 inhibitor tofogliflozin on Urine Albumin-to-Creatinine Ratio (UACR) compared to metformin in patients with type 2 diabetes with chronic kidney disease (CKD).
CONDITIONS
Official Title
Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Type 2 diabetic patients
- Patients aged 20 years or older at the time of obtaining consent
- Patients with HbA1c between 6.5% and 9.0% within 13 weeks before consent (after at least 4 weeks without SGLT2 inhibitor or metformin)
- Patients judged by their doctor to need a diabetic drug or requiring an additional diabetic drug
- Patients receiving RAS inhibitors (ARB, ARNI, ACE inhibitors, direct renin inhibitors) for 4 weeks or longer
- Patients with eGFR of 30 or more (mL/min/1.73m2) within 13 weeks before consent (after at least 4 weeks without SGLT2 inhibitor or metformin)
- Patients with urinary albumin/creatinine ratio (UACR) of 30 or more and less than 2000 (mg/gCr) within 13 weeks before consent (after at least 4 weeks without SGLT2 inhibitor or metformin)
- Patients who have provided written informed consent
You will not qualify if you...
- Patients treated with SGLT2 inhibitor or metformin within 13 weeks before consent
- Dialysis patients
- Patients with a history of severe hypoglycemia
- Patients with hypersensitivity to SGLT2 inhibitor or metformin
- Pregnant women, breastfeeding patients, or patients wishing to have children
- Patients with BMI of 35 kg/m2 or more within 13 weeks before consent
- Patients contraindicated for the study drug
- Patients deemed inappropriate for the study by the attending physician
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shinshu University
Matsumoto, Nagano, Japan, 390-8621
Actively Recruiting
Research Team
K
Koichiro Kuwahara, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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