AIPRI Study 1996.

Methods	Study design: parallel, double‐blind RCT Duration of study: January 1989 to December 1990 Follow‐up: 3 years ADPKD assessment: unclear
Participants	Countries: Italy, France, Germany Setting: international multicentre study (49 centres) Patients with SCr 1.5 to 4.0 mg/dL (133 to 354 mmol/L); 24‐hour estimated CrCl 30 to 60 mL/min with variations > 30% in at least 3 measurements Number: treatment group (300); control group (283) (64 diagnosed with ADPKD) Mean age ± SD (years): treatment group (51± 13); control group (51 ± 12) Sex (M/F): treatment group (220/80); control group (201/82) Exclusion criteria: therapy‐resistant oedema; treatment with corticosteroids, NSAIDs, or immunosuppressive drugs; UPE > 10 g/24 h; serum albumin < 25 g/L; renovascular hypertension; malignant hypertension or MI or CVA in the 6 months preceding the study; CHF (NYHA class III or IV); insulin‐dependent DM; elevated serum AST concentration; collagen disease; obstructive uropathy; cancer; chronic cough; history of ACEi allergy; drug or alcohol abuse; pregnancy
Interventions	Treatment group Benazepril: 10 mg/d Control group Placebo Duration of intervention 3 years
Outcomes	Doubling SCr concentration SCr UPE DBP
Notes	Separate data on ADPKD patients were not provided Funding: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information to permit judgement
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double blind
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgement
Incomplete outcome data (attrition bias) All outcomes	High risk	"Sixty‐eight patients in the benazepril group and 61 in the placebo group did not complete the study be cause of death, other adverse events, lack of cooperation, or protocol violations"
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgement
Other bias	Unclear risk	Insufficient information to permit judgement