Multicenter, open-label, extension trial to evaluate the long-term efficacy and safety of early versus delayed treatment with tolvaptan in autosomal dominant polycystic kidney disease: the TEMPO 4:4 Trial.

The nominally significant difference between early- and delayed-treatment groups was maintained at each time point, demonstrating that the effect of tolvaptan on slowing renal function decline in TEMPO 3:4 was maintained for an additional 2 years in TEMPO 4:4 (3.15 mL/min/1.73 m 2 , P < 0.001), (Figure 3 ).

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