This long awaited clinical trial was presented on November 3, 2012 at the American Society of Nephrology Kidney Week.
This multicenter, double-blind, placebo-controlled trial enrolled patients with autosomal dominant polycystic kidney disease who were age 18 to 50 years, had total kidney volume of ≥ 750 ml and an estimated CrCl of ≥ 60 ml per min. In a 2:1 ratio, patients received the V2-receptor antagonist tolvaptan or placebo.
There was a significant reduction in the primary outcome (annual rate of change in total kidney volume), with the tolvaptan group increasing at 2.8% per year versus 5.5% per year in the placebo group (P<0.001).
A secondary end point of a composite of time to clinical progression (worsening kidney function, kidney pain, hypertension, and albuminuria) was seen less often in the intervention group with 44 vs. 50 events per 100 follow-up-years (P=0.01).
Tolvaptan was associated with a slower decline in kidney function (1/serum creatinine) at −2.61 [mg/ml]−1 per year vs. −3.81 [mg/ml]−1 per year, (P<0.001).
The tolvaptan group had higher rates of symptoms such thirst, polyuria and transaminitis which contributed to a higher discontinuation rate (23%, vs. 14% in the placebo group). No patients in the trial reached end-stage renal disease.
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