Diabetic Kidney Disease Hyperuricemia Albuminuria Type 2 Diabetes Mellitus Chronic Kidney Disease Diabetic Kidney Disease Albuminuria Hyperuricemia Febuxostat SGLT2 Inhibitors Uric Acid Chronic Kidney Disease Randomized Controlled Trial
Conditions
Interventions
Participants will receive standard therapy including an SGLT2 inhibitor together with febuxostat. Febuxostat will be administered orally once daily in addition to the participant usual treatment. Back
Active Comparator Drug,Active Comparator Drug
SGLT2 inhibitor plus febuxostat ,SGLT2 inhibitor
Sponsors
Buriram Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age 18 years or older 2.Diagnosis of type 2 diabetes mellitus 3.Chronic kidney disease stage G2 to G4 with eGFR 25 to 60 mL per minute per 1.73 m2 4.Severe albuminuria defined as UACR 300 mg per g or higher 5.Hyperuricemia defined as serum uric acid 7 mg per dL or higher 6.Receiving a stable dose of ACE inhibitor or angiotensin receptor blocker for at least 4 weeks before enrollment 7.Receiving a stable dose of SGLT2 inhibitor for at least 4 weeks before enrollment 8.Able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1.Estimated glomerular filtration rate less than 25 mL per minute per 1.73 m2 or receiving renal replacement therapy including dialysis 2.Acute kidney injury or rapidly progressive decline in kidney function within the past 3 months 3.Liver enzyme elevation defined as alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal 4.Symptomatic gout requiring urate lowering therapy presence of tophi or history of uric acid kidney stones requiring treatment 5.Known hypersensitivity to febuxostat or severe hypersensitivity to xanthine oxidase inhibitors 6.Current use of azathioprine or mercaptopurine 7.Pregnancy or breastfeeding 8.Any medical condition that in the opinion of the investigator makes participation unsafe including uncontrolled hypertension severe dehydration or severe infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in urine albumin to creatinine ratio Change from baseline to 12 weeks milligrams of albumin per gram of creatinine | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum uric acid level Change from baseline to 12 weeks mg/dL,Change in estimated glomerular filtration rate Change from baseline to 12 weeks mL/min/1.73 m2,Change in systolic blood pressure Change from baseline to 12 weeks mmHg,Change in diastolic blood pressure Change from baseline to 12 weeks mmHg,Adverse events Up to 12 weeks Number of participants with adverse events | — |
Countries
Thailand
Contacts
Public ContactTheerapun Boonsayomphu
Buriram Hospital
Outcome results
None listed