Tolvaptan in Later-Stage Autosomal Dominant Polycystic Kidney Disease.
Publication/Presentation Date
11-16-2017
Abstract
BACKGROUND: In a previous trial involving patients with early autosomal dominant polycystic kidney disease (ADPKD; estimated creatinine clearance, ≥60 ml per minute), the vasopressin V
METHODS: We conducted a phase 3, randomized withdrawal, multicenter, placebo-controlled, double-blind trial. After an 8-week prerandomization period that included sequential placebo and tolvaptan run-in phases, during which each patient's ability to take tolvaptan without dose-limiting side effects was assessed, 1370 patients with ADPKD who were either 18 to 55 years of age with an estimated GFR of 25 to 65 ml per minute per 1.73 m
RESULTS: The change from baseline in the estimated GFR was -2.34 ml per minute per 1.73 m
CONCLUSIONS: Tolvaptan resulted in a slower decline than placebo in the estimated GFR over a 1-year period in patients with later-stage ADPKD. (Funded by Otsuka Pharmaceuticals and Otsuka Pharmaceutical Development and Commercialization; REPRISE ClinicalTrials.gov number, NCT02160145 .).
Volume
377
Issue
20
First Page
1930
Last Page
1942
ISSN
1533-4406
Published In/Presented At
Torres, V. E., Chapman, A. B., Devuyst, O., Gansevoort, R. T., Perrone, R. D., Koch, G., Ouyang, J., McQuade, R. D., Blais, J. D., Czerwiec, F. S., Sergeyeva, O., & REPRISE Trial Investigators (2017). Tolvaptan in Later-Stage Autosomal Dominant Polycystic Kidney Disease. The New England journal of medicine, 377(20), 1930–1942. https://doi.org/10.1056/NEJMoa1710030
Disciplines
Medicine and Health Sciences
PubMedID
29105594
Department(s)
Department of Medicine
Document Type
Article