6/29/23, 1:10 AM REPRISE Pathway Feedback Search Clinical Topics Home Studies REPRISE REPRISE Disease Autosomal dominant polycystic Trial question What is the effect of tolvaptan in patients with later-stage autosomal dominant polycystic kidney disease? Study design Multi-center Double blinded RCT Population Characteristics of study participants 50.0% female N = 1370 50.0% male 1370 patients (690 female, 680 male) Inclusion criteria: patients with later-stage autosomal dominant polycystic kidney disease Key exclusion criteria: pregnant or breastfeeding women, need for chronic diuretic use, hepatic impairment or liver function abnormalities other than that expected for ADPKD, advanced diabetes, or contraindications to required trial assessments Interventions N=683 tolvaptan (daily morning and after doses of 90 mg and 30 mg; 60 mg and 30 mg; or 45 mg and 15 mg, or less for 12 months) N=687 placebo (mock morning and afternoon doses of 90 mg and 30 mg; 60 mg and 30 mg; or 45 mg and 15 mg, or less for 12 months) https://web.pathway.md/studies/recJGuV16VwtxRLiD 1/2 6/29/23, 1:10 AM REPRISE Pathway Primary outcome Significant increase in decline in estimated GFR at 1 year (-2.34 vs. -3.61; difference 1.27, 95% CI 0.86 to 1.68) Secondary outcomes Significant increase in slopes of the change in the estimated GFR at 1 year (-3.16 vs. -4.17; difference 1.01, 95% CI 0.62 to 1.4) Safety outcomes No significant difference in the rates of new or worsening adverse events. Conclusion In patients with later-stage autosomal dominant polycystic kidney disease, tolvaptan was superior to placebo with respect to decline in estimated GFR at 1 year. Reference Torres VE, Chapman AB, Devuyst O et al. Tolvaptan in Later-Stage Autosomal Dominant Polycystic Kidney Disease. N Engl J Med. 2017 Nov 16;377(20):1930-1942. Open reference URL https://web.pathway.md/studies/recJGuV16VwtxRLiD 2/2