Status:
COMPLETED
Metformin in Kidney Disease
Lead Sponsor:
VA Office of Research and Development
Conditions:
Chronic Kidney Disease
Cardiovascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Chronic kidney disease (CKD) is a major global health problem associated with substantial costs and resource utilization. Currently, CKD affects more than 500 million people worldwide. Patients with C...
Eligibility Criteria
Inclusion
- Age 18 years old;
- Ability to give informed consent;
- Life expectancy greater than 6 months;
- Estimated GFR 30-59 ml/min/1.73m\^2;
- Overweight (BMI \>=25 to \< 30 kg/m\^2) or obese (BMI \>=30 kg/m\^2); or normal (BMI \>=18.5 to \<25 kg/m\^2) if pre-diabetic or insulin resistant.
Exclusion
- Pregnancy or breast feeding;
- Presence or history of Diabetes Mellitus type I or II
- History of metformin use or any insulin sensitizer or any drug for the treatment of metabolic syndrome over the last one year;
- Any acute kidney injury episode in the last 4 months due to the risk of recurrent AKI;
- Proteinuria of \> 5 g in 24 hours determined by a 24 hour urine collection or PCR \> 4.5;
- Uncontrolled hypertension with systolic blood pressure 160 mmHg and diastolic blood pressure 100 mmHg;
- Patients with new changes to their antihypertensive regimen over the last 1 month;
- Severe, unstable, or active inflammatory disease; active infection including seropositive HIV, Hepatitis B or C; active connective tissue disorder; or moderate to severe liver disease;
- Decompensated heart failure;
- Recent hospitalization or surgical procedure within 1 month prior to the study for any cause;
- Current active malignancy or cancer history in the prior 5 years (excluding squamous cell and basal cell skin cancers);
- Known intolerance to the study drug;
- Patient receiving oral or injected steroids
- Use of any investigational product or device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments;
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT02252081
Start Date
October 1 2014
End Date
December 31 2019
Last Update
November 4 2021
Active Locations (1)
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1
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637