Hyperuricemia and Diabetic Nephropathy

Assiut University

Status

Unknown

Conditions

Diabetic Nephropathies

Hyperuricemia

Treatments

Drug: Febuxostat

Study type

Observational

Funder types

Other

Identifiers

NCT04799925

Diabetic Nephropathy Uric Acid

Details and patient eligibility

About

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.

Full 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).

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.