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Hyperuricemia and Diabetic Nephropathy

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ClinicalTrials.gov Identifier: NCT04799925
Recruitment Status : Not yet recruiting
First Posted : March 16, 2021
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
mohammad ragab eldremi, Assiut University

Study Description
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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
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
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Study Type : Observational
Estimated 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.
Estimated Study Start Date : April 15, 2021
Estimated Primary Completion Date : April 15, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Febuxostat

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04799925


Contacts
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Contact: Mohamed Ragab Eldremi 00201114430050 muhammadragab90@gmail.com

Sponsors and Collaborators
Assiut University
  Study Documents (Full-Text)

Documents provided by mohammad ragab eldremi, Assiut University:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] February 20, 2021

More Information
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Responsible Party: mohammad ragab eldremi, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04799925    
Other Study ID Numbers: Diabetic Nephropathy Uric Acid
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Hyperuricemia
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
 Endocrine System Diseases
Pathologic Processes
Febuxostat
Gout Suppressants
Antirheumatic Agents