Hyperuricemia and Diabetic Nephropathy
Effect of Treatment of Hyperuricemia on Progression of Diabetic Nephropathy in Patients With Type II Diabetes Mellitus and Stage III Chronic Kidney Disease.
1 other identifier
observational
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2021
CompletedFirst Posted
Study publicly available on registry
March 16, 2021
CompletedStudy Start
First participant enrolled
April 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedMarch 16, 2021
March 1, 2021
1 year
March 5, 2021
March 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
Intervention group
Hyperuricemic group will be treated with uric acid lowering drug (febuxostat 80 mg once daily for 6 months).
Placebo group
Hyperuricemic group will take placebo pills.
Interventions
uric acid lowering agent. dose: 80 mg once daily. duration: for 6 months
Eligibility 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).
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 5, 2021
First Posted
March 16, 2021
Study Start
April 15, 2021
Primary Completion
April 15, 2022
Study Completion
December 30, 2022
Last Updated
March 16, 2021
Record last verified: 2021-03