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Hyperuricemia and Diabetic Nephropathy

Conditions
Hyperuricemia
Diabetic Nephropathies
Interventions
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).

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
GroupInterventionDescription
Intervention groupFebuxostatHyperuricemic group will be treated with uric acid lowering drug (febuxostat 80 mg once daily for 6 months).
Primary Outcome Measures
NameTimeMethod
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.

Secondary Outcome Measures
NameTimeMethod

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