Hyperuricemia and Diabetic Nephropathy

• Conditions: Hyperuricemia; Diabetic Nephropathies
• Interventions: Drug: Febuxostat

• Registration Number: NCT04799925
• Lead Sponsor: Assiut University

Brief 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).

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-12
• Last Update Submitted: 2021-03-12
• Study First Posted: 2021-03-16
• Last Update Posted: 2021-03-16
• Study Start: 2021-04-15
• Primary Completion: 2022-04-15
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patient population will include both males and females above the age of 18 years with T2DM and Diabetic Nephropathy stage 3 CKD (eGFR: 31-59).

Exclusion Criteria

• Patients with history of hypothyroidism, alcoholism, urinary tract infections, glomerulonephritis, myeloproliferative disorders and gout "as gout is a common inflammatory arthropathy characterized by painful and swollen joints resulting from precipitating uric acid crystals but hyperuricemia is commonly asymptomatic" or on drugs capable of inducing Hyperuricemia will be excluded from the study.
• Any patient will develop acute kidney injury episode at any time of the study will be excluded from the study.
• Patients with uncontrolled hypertension will be excluded from the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention group	Febuxostat	Hyperuricemic group will be treated with uric acid lowering drug (febuxostat 80 mg once daily for 6 months).

Primary Outcome Measures

Name	Time	Method
Effect of treatment of hyperuricemia on estimated Glomerular Filtration Rate by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.	6 months from September 2021 to march 2022.	Number of Participants with type 2 Diabetes Mellitus and stage 3 Chronic Kidney Disease (eGFR: 31:59) will be treated with uric acid lowering drug (febuxostat, 80 mg, once daily) for 6 months to detect the effect of treatment of hyperuricemia on estimated Glomerular Filtration Rate by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.