Tolvaptan pharmacokinetics and pharmacodynamics in adolescents with autosomal dominant polycystic kidney disease.

ABSTRACT: Tolvaptan, an oral selective antagonist of the vasopressin V2 receptor, is the only medication for autosomal dominant polycystic kidney disease (ADPKD) with disease-modifying properties in adults at risk of rapid progression. The pharmacokinetics (PK) and pharmacodynamics (PD) of tolvaptan have been well characterized in adults with ADPKD, but data are lacking for adolescents. We assessed prespecified PK/PD endpoints from a randomized clinical trial of tolvaptan in adolescents (ages 12-17 years) with ADPKD (NCT02964273). Dense 24-h PK and PD sampling was conducted in a subgroup of 20 trial participants after a minimum of 1 month on treatment. Endpoints included standard PK parameters and PD endpoints of urine volume, fluid intake, fluid balance, and clearance of sodium, creatinine, and fre

SUBMITTER: Shoaf SE 

PROVIDER: S-EPMC12712010 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature