Phase III trial of Samsca slows kidney function decline in polycystic kidney disease.- Otsuka.
In the phase III, multi-center, randomized withdrawal, placebo controlled, double-blind REPRISE trial Samsca (tolvaptan), from Otsuka, slowed kidney function decline (as measured by eGFR) by 35% over 1-year in individuals with later-stage autosomal dominant polycystic kidney disease (ADPKD). In the study of 1370 ADPKD patients, annualized eGFR change from pre-treatment baseline to post-treatment follow-up was -2.34 mL/min/1.73 m2 with tolvaptan versus -3.61 mL/min/1.73 m2 with placebo.
This, in addition to data from other trials with tolvaptan for ADPKD, means that it may delay the need for a kidney transplant or dialysis, and represents a milestone in the investigation of a condition for which there are currently no approved treatments. The results will be presented at ASN Kidney Week 2017.
Comment: there are no alternative treatments: Samsca is the first drug treatment in the world to slow the progression of autosomal dominant polycystic kidney disease.
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