At the time of this trial, it was known that ACE inhibitors or ARBs delay the progression of renal disease in patients with type 1 diabetes and non diabetic patients who have a overt property. However, it was unknown if this benefit extended to patients with type 2 diabetes. This trial was designed to examine just that. This trial enrolled 1513 patients aged 31 to 70 years old who had type 2 diabetes and nephropathy. Nephropathy was defined as a presence of ACR of at least 300mg/g or a rate of protein excretion of at least 500mg/day in patients with a serum creatinine of 1.3-3.0mg/dL. During a six-week screening phase, patients received their standard in hypertensive therapy. If they were on ACE or ARBs, they were transitioned to alternative medications. They were then randomized to losartan or placebo with other BP medications as needed to target a BP of <140/90. The primary outcome was the time to the first event of the composite end point of a doubling of serum creatinine, ESKD, or death. ESKD was defined as the need for long-term dialysis, or death. The mean follow-up time was 3.4 years. Losartan led to a 16% risk reduction for the primary outcome. This was a well-designed trial that added to our knowledge of the benefits of ACE and ARBs.
The RENAAL Trial: Brenner, B. M., Cooper, M. E., De Zeeuw, D., Keane, W. F., Mitch, W. E., Parving, H. H., ... & Shahinfar, S. (2001). Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. New England journal of medicine, 345(12), 861-869.
The RENAAL Trial PMID: 11565518
Useful Summaries: