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Clinical Trial Details

Trial ID: L5805
Source ID: NCT05469659
Associated Drug: Tofogliflozin
Title: Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD)
Acronym: TRUTH-DKD
Status: RECRUITING
Study Results: NO
Results:
Conditions: T2DM (Type 2 Diabetes Mellitus)|Metformin|SGLT2-Inhibitors
Interventions: DRUG: Tofogliflozin|DRUG: Metformin
Outcome Measures: Primary: Urine albumin-to-creatinine ratio (UACR), Change from baseline in urine albumin-to-creatinine ratio (UACR) after 52 weeks treatment., Up to 52 weeks | Secondary: Urine albumin-to-creatinine ratio (UACR), Change from baseline in urine albumin-to-creatinine ratio (UACR) after 26 and 104 weeks treatment., Up to 26 and 104 weeks|Urine albumin-to-creatinine ratio (UACR), Change rates from baseline in urine albumin-to-creatinine ratio (UACR) after 26, 52 and 104weeks treatment., Up to 26, 52 and 104 weeks|Change slope in eGFR, Change slope in eGFR, Up to 52 and 104 weeks|HbA1c, Change in HbA1c, Up to 52 and 104 weeks|Body weight, Changes in body weight, Up to 52 and 104 weeks|Systolic / diastolic blood pressure, Changes in systolic / diastolic blood pressure, Up to 52 and 104 weeks|Total serum proteins, Changes in total serum proteins, Up to 52 and 104 weeks|Serum albumin, Changes in serum albumin, Up to 52 and 104 weeks|Uric acid, Changes in uric acid, Up to 52 and 104 weeks|Hematocrit, Changes in hematocrit, Up to 52 and 104 weeks|Hemoglobin, Changes in hemoglobin, Up to 52 and 104 weeks|Red blood cell count, Changes in red blood cell count, Up to 52 and 104 weeks|Pulse rate, Changes in pulse rate, Up to 52 and 104 weeks|Triglyceride, Changes in triglyceride, Up to 52 and 104 weeks|Low-density lipoprotein, Changes in low-density lipoprotein, Up to 52 and 104 weeks|High-density lipoprotein, Changes in high-density lipoprotein, Up to 52 and 104 weeks|Albuminuria class, Transition of albuminuria class, Up to 104 weeks
Sponsor/Collaborators: Sponsor: Shinshu University | Collaborators: Kowa Company, Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 120
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-09-22
Completion Date: 2026-10-30
Results First Posted:
Last Update Posted: 2022-07-22
Locations: Shinshu University, Matsumoto, Nagano, 390-8621, Japan
URL: https://clinicaltrials.gov/show/NCT05469659