Effect of Tofogliflozin on Urinary Albumin-to-Creatinine Ratio vs. Metformin in Diabetic Kidney Disease: Rationale and Study Protocol of the TRUTH-DKD Trial.
Kazuhiro Kimura, Yoshiko Takagi, Makoto Harada...
https://pubmed.ncbi.nlm.nih.gov/41252113Actively Recruiting
Phase 2
Age: 20Years +
All Genders
ID05469659
Effect of Tofogliflozin on Urine Albumin-to-Creatinine Ratio Compared to Metformin Hydrochloride in Diabetic Kidney Disease
Led by Shinshu University · Updated on 2022-07-22
120
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the effects of the drug tofogliflozin on urine albumin-to-creatinine ratio (UACR) in people with type 2 diabetes who also have chronic kidney disease (CKD). This phase 2, multicenter, randomized, open-label study compares tofogliflozin to metformin, a common diabetes medication. The study aims to assess how these treatments affect kidney function and other health markers over time. Participants will be randomly assigned to receive either tofogliflozin or metformin. Tofogliflozin is taken as a 20 mg oral dose once daily, before or after breakfast, for up to 104 weeks. Metformin treatment starts at 500 mg daily, taken in two to three divided doses with meals, with the dose adjusted as needed up to 2,250 mg daily, also for 104 weeks. Randomization considers factors such as UACR level, estimated glomerular filtration rate (eGFR), and age. During the study, participants will have regular assessments including UACR, eGFR, blood sugar control (HbA1c), body weight, blood pressure, and various blood markers like serum proteins and lipids. These measurements will be taken at multiple time points over 52 to 104 weeks to monitor treatment effects and safety. The primary focus is the change in UACR after 52 weeks, with ongoing monitoring throughout the study period.
CONDITIONS
Brief Title
Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD)
Who Can Participate
Age: 20Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Type 2 diabetic patients
- Patients aged 20 years or older at consent
- HbA1c between 6.5% and 9.0% within 13 weeks before consent
- Patients needing diabetic medication or adding one
- Receiving RAS inhibitors (ARB, ARNI, ACE inhibitors, direct renin inhibitors) for 4 weeks or more
- eGFR of 30 mL/min/1.73m2 or higher within 13 weeks before consent
- Urinary albumin-to-creatinine ratio (UACR) of 30 to less than 2000 mg/gCr within 13 weeks before consent
- Provided written informed consent voluntarily
You will not qualify if you...
- Treatment with SGLT2 inhibitor or metformin within 13 weeks before consent
- Dialysis patients
- History of severe hypoglycemia
- Hypersensitivity to SGLT2 inhibitor or metformin
- Pregnant or breastfeeding women, or those wishing to have children
- BMI of 35 kg/m2 or higher within 13 weeks before consent
- Contraindications to the study drugs
- Other conditions deemed unsuitable by the attending physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 104 weeks
Participants receive either tofogliflozin or metformin daily for their diabetic kidney disease.
Regular visits during treatment period
Trial Site Locations
Total: 1 location
1
Shinshu University
Matsumoto, Nagano, Japan, 390-8621
Actively Recruiting
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Research Team
K
Koichiro Kuwahara, MD, PhD
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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Published Research Related To This Trial
Metformin for preventing the progression of chronic kidney disease.
Ragada El-Damanawi, Isabelle Kitty Stanley, Christine Staatz...
https://pubmed.ncbi.nlm.nih.gov/38837240