The NOCTURNE Randomized Trial Comparing 2 Tolvaptan Formulations

KI Reports
Ronald D PerroneSusan E Shoaf

Abstract

Tolvaptan, a treatment for autosomal dominant polycystic kidney disease (ADPKD), inhibits vasopressin V2 receptor signaling, which causes aquaretic adverse events (AAEs). The short-term efficacy and tolerability of a once-daily, modified-release (MR) formulation was assessed relative to the twice-daily, immediate-release (IR) formulation. This Phase 2 multicenter, randomized (1:1:1:1), placebo-controlled, double-blind, placebo-masked, parallel-group study (NCT01451827) compared tolvaptan MR 50 mg once daily or tolvaptan MR 80 mg once daily with tolvaptan IR 60/30 mg daily split dose and placebo over 8 weeks in 177 subjects. The primary endpoint was percent change from baseline in total kidney volume (TKV) at week 3. Other endpoints included tolerability, assessed by adverse events and quality of life (QOL) measures. Mean percentage decreases in TKV at week 3 were observed for the pooled group of all (MR+IR) tolvaptan-treated subjects (-2.07%), tolvaptan MR 80 mg (-2.55%), and tolvaptan MR 50 mg (-2.46%) versus placebo (0.09%; P < 0.02 for each comparison with placebo), whereas the decrease with tolvaptan IR 60/30 mg (-1.17%; P = 0.24) did not reach significance. All tolvaptan regimens were associated with AAEs, but scores on AD...Continue Reading

References

May 6, 2009·Annals of Internal Medicine·Andrew S LeveyUNKNOWN CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
Nov 6, 2012·The New England Journal of Medicine·Vicente E TorresUNKNOWN TEMPO 3:4 Trial Investigators
Jun 6, 2013·Current Opinion in Nephrology and Hypertension·Olivier Devuyst, Vicente E Torres
Dec 18, 2013·Journal of the American Society of Nephrology : JASN·Vicente E Torres, Peter C Harris
Jul 21, 2015·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Paul B WatkinsChristopher A Zimmer
Dec 7, 2016·Journal of the American Society of Nephrology : JASN·Olivier DevuystFrank S Czerwiec
Nov 19, 2017·American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation·Dorothee OberdhanRonald D Perrone
Dec 24, 2018·American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation·Bart J KramersRon T Gansevoort
Jun 11, 2020·KI Reports·Ronald D PerroneSusan E Shoaf

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Citations

Jul 9, 2021·Therapeutics and Clinical Risk Management·Ioannis Bellos

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Clinical Trials Mentioned

NCT01451827
NCT01210560
NCT01336972

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