NCT04799925

Hyperuricemia and Diabetic Nephropathy

Effect of Treatment of Hyperuricemia on Progression of Diabetic Nephropathy in Patients With Type II Diabetes Mellitus and Stage III Chronic Kidney Disease.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to detect the effect of treatment of hyperuricemia on eGFR (Estimated Glomerular Filtration Rate) as an objective criterion for assessment of progression of diabetic nephropathy in patients with Type 2 Diabetes Mellitus.

Detailed description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Febuxostat (80 mg, once daily) or Placebo (once daily) in patients with Type 2 Diabetes Mellitus and Stage 3 Chronic Kidney Disease (Estimated Glomerular Filtration Rate 31:59).

Conditions

• Hyperuricemia
• Diabetic Nephropathies

Interventions

Type	Name	Description
DRUG	Febuxostat	uric acid lowering agent. dose: 80 mg once daily. duration: for 6 months

Timeline

• Start date: 2021-04-15
• Primary completion: 2022-04-15
• Completion: 2022-12-30
• First posted: 2021-03-16
• Last updated: 2021-03-16