Hyperuricemia and Diabetic Nephropathy

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04799925

Collaborator

(none)

200

Enrollment

20.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperuricemia Diabetic Nephropathies	Drug: Febuxostat

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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.

Anticipated Study Start Date :

Apr 15, 2021

Anticipated Primary Completion Date :

Apr 15, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Intervention group Hyperuricemic group will be treated with uric acid lowering drug (febuxostat 80 mg once daily for 6 months).	Drug: Febuxostat uric acid lowering agent. dose: 80 mg once daily. duration: for 6 months
Placebo group Hyperuricemic group will take placebo pills.

Arm

Intervention/Treatment

Intervention group

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

Drug: Febuxostat

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

Placebo group

Hyperuricemic group will take placebo pills.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Feb 20, 2021

More Information

Publications

None provided.

Responsible Party:

mohammad ragab eldremi, Principal Investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT04799925

Other Study ID Numbers:

Diabetic Nephropathy Uric Acid

First Posted:

Mar 16, 2021

Last Update Posted:

Mar 16, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Kidney Diseases

Diabetic Nephropathies

Hyperuricemia

Febuxostat

Study Results

No Results Posted as of Mar 16, 2021