Hyperuricemia and Diabetic Nephropathy

NCT ID: NCT04799925

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2022-12-30

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).

Conditions

Hyperuricemia; Diabetic Nephropathies

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Intervention group

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

Febuxostat

Intervention Type: DRUG

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

Placebo group

Hyperuricemic group will take placebo pills.

No interventions assigned to this group

Interventions

Febuxostat

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

mohammad ragab eldremi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohamed Ragab Eldremi

Role: CONTACT

muhammadragab90@gmail.com

00201114430050

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Diabetic Nephropathy Uric Acid

Identifier Type: -

Identifier Source: org_study_id