The Safety and Efficacy of Angiotensin II Receptor Blockers (ARBs) in Diabetic Patients with Advanced Chronic Kidney Disease
- Conditions
- Diabetic patients with advanced chronic kidney disease (CKD) who have newly received ARBschronic kidney disease, diabetes mellitus, angiotensin II receptor blockers, renin-angiotensin system inhibitors
- Registration Number
- TCTR20210526006
- Lead Sponsor
- Division of Nephrology, Department of Internal Medicine, Thammasat University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 165
Inclusion Criteria
Patients with diabetes mellitus and advanced CKD, defines as estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2 will be included. The patients who newly start treatment with any ARBs during eGFR less than 30 ml/min/1.73m2 will be compared with patients who do not receive any ACEi/ARBs.
Exclusion Criteria
1. age of < 18 years old, 2. eGFR < 6 ml/min/1.73 m2, 3. currently on renal replacement therapy, 4. patients who have currently received ACEi/ARBs before the cohort entry, 5. patients whose medical data could not be accessed.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method time to the first event of composite major adverse kidney events (MAKE) including a doubling serum creatinine level, renal replacement therapy, and death. 36 months after the cohort entry month
- Secondary Outcome Measures
Name Time Method time to the first event of major adverse cardiovascular events (MACE) that included non-fatal myocardial ischemia, non-fatal stroke, and death 36 months after the cohort entry month,time to the first event of hospitalization heart failure 36 months after the cohort entry month,time to the first event of eGFR decline more than 30% from baseline 36 months after the cohort entry month,eGFR decline overtime 36 months after the cohort entry ml/min/month,time to the first event of hyperkalemia 36 months after the cohort entry month