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NCT04799925 Clinical Trial

Hyperuricemia and Diabetic Nephropathy

Hyperuricemia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04799925
Other study ID # Diabetic Nephropathy Uric Acid
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 15, 2021
Est. completion date December 30, 2022

Study information
Verified date March 2021
Source Assiut University
Contact Mohamed Ragab Eldremi
Phone 00201114430050
Email muhammadragab90@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date December 30, 2022
Est. primary completion date April 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Febuxostat
uric acid lowering agent. dose: 80 mg once daily. duration: for 6 months

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Outcome
Type Measure Description Time frame Safety issue
Primary Effect of treatment of hyperuricemia on estimated Glomerular Filtration Rate by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation. 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. 6 months from September 2021 to march 2022.
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