RENAAL 2001

Methods	Country: USA Setting/Design: Multicentre Time frame: NS Randomisation method: NS Blinding ‐ Participants: Yes ‐ Investigators: Yes ‐ Outcome assessors: Yes ‐ Data analysis: No Intention‐to‐treat: Yes Follow‐up period: mean 3.4 years Loss to follow‐up: 3
Participants	Inclusion criteria DM: Type 2 Nephropathy (presence on 2 occasions of a ratio of urinary albumin to urinary creatinine from a first morning specimen of at least 300 and SCr between 1.3‐3 mg/dL with a lower limit of 1.5 mg/dL for male patients weighing more than 60 kg) Age: 31‐70 years Losartan group Number: 751 Age: 60 (7) Sex (M/F): 462/289 Placebo group Number: 762 Age: 60 (7) Sex (M/F): 494/268 Exclusion criteria DM type 1 or non‐diabetic renal disease MI or CAB grafting within the previous month CVA or percutaneous transluminal coronary angioplasty within the previous 6 months Transient ischemic attack within the previous year History of heart failure
Interventions	Losartan group 50‐100 mg/d Placebo group Co‐interventions CCB, diuretics, alpha‐blockers, beta‐blockers and centrally acting agents
Outcomes	Doubling of SCr ESKD Death Morbidity and mortality from cardiovascular causes Proteinuria Rate of progression of renal disease
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear