NCT01660243

Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis

A Phase 2, Randomized, Double-blind, Placebo-controlled, Fixed-dose, Parallel-group, Multicenter, Efficacy, and Safety Study of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Toray Industries, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to investigate the efficacy of MT-9938 compared with placebo after 2 weeks, to continue to evaluate efficacy for an additional 6 weeks, and to explore the effect of a reduction in itching intensity on health-related Quality of Life(QoL) domains, especially those which recent research suggests have a positive correlation with overall survival for this patient group. The study will consist of the following phases: Screening (1 to 2 weeks), Run in (1 week), double-blind Treatment (8 weeks), Washout (1 week) culminating in a Follow-up Visit (1 week after the last dose).

Detailed description

This study has been terminated because of insufficient patient recruitment. There were no safety concerns.

Conditions

• Uremic Pruritus

Interventions

Type	Name	Description
DRUG	Nalfurafine hydrochloride(MT-9938) 2.5μg	2.5 μg (2capsules) once daily for 8 weeks
DRUG	Nalfurafine hydrochloride(MT-9938) 5μg	5 μg (2capsules) once daily for 8 weeks
DRUG	Nalfurafine hydrochloride(MT-9938) 10μg	10 μg (2capsules) once daily for 8 weeks
DRUG	Placebo	Placebo (2capsules) once daily for 8 weeks

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-08-08
• Last updated: 2022-02-09
• Results posted: 2022-02-09

Locations

4 sites across 1 country: United States