drugset / Trial / NCT01500590

Effect of Renin-angiotensin System Blockers on Glomerular Filtration Rate in Patients With Hypertension, Type 2 Diabetes With Normoalbuminuria

NCT01500590

Phase 4 Unknown 1400 enrolled Hospital Authority, Hong Kong
RandomizedParallel-groupOpen-labelTreatment

Summary

Diabetes is the leading cause of chronic kidney disease in developed countries. About 30-40% of patients with type 1 and type 2 diabetes mellitus will develop diabetic nephropathy. Microalbuminuria is often used as an early predictor of diabetic nephropathy. Many studies already demonstrated the renoprotective effect of Renin-angiotensin-system (RAS) blockers in patients with varying degree of albuminuria, few studies focus on studying the decline in glomerular filtration rate (GFR) among patients with normoalbuminuria. However a substantial number of diabetic patients exist with sub-normal GFR without microalbumin excretion. From literature, diabetes mellitus will have faster decline in GFR but the investigators do not know whether such decline can be slowed down by the use of RAS blockers as compared with other anti-hypertensive drugs. This Study investigate the effect of early treatment with RAS blockers on the decline rate of GFR in diabetic patients with normoalbuminuria.

Timeline

Start
2011-11
Primary completion
2018-08
Completion
2019-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amlodipine Other / unclassified 2.5 mg
Comparator Amlodipine Other / unclassified 10 mg
Comparator Indapamide Small molecule 2.5 mg
Subject Irbesartan Small molecule 150 mg
Subject Irbesartan Small molecule 300 mg
Comparator Methyldopa Unknown 125 mg
Comparator Methyldopa Unknown 500 mg
Comparator Metoprolol Other / unclassified 25 mg
Comparator Metoprolol Other / unclassified 100 mg
Subject Ramipril Small molecule 2.5 mg
Subject Ramipril Small molecule 10 mg
Comparator nifedipine retard Unknown 20 mg
Comparator nifedipine retard Unknown 40 mg