Hyperuricemia and Diabetic Nephropathy

March 12, 2021 updated by: mohammad ragab eldremi, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 15, 2021

Primary Completion (Anticipated)

April 15, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diabetic Nephropathy Uric Acid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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