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NCT01660243 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis
A Phase 2 study, sponsored by Toray Industries.
- Terminated
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT01660243: Clinical Trial Phase 2 study, sponsored by Toray Industries.
NCT01660243 is a Phase 2 study that was terminated before completion, run by Toray Industries. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01660243, a Phase 2 study, was terminated before completion, sponsored by Toray Industries.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study 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).
Primary Outcome
The subject indicated the number on the line from left (0:no itching) to right (10:worst itch I have ever experienced). Assessments was made twice daily using an electronic Patient Reported Outcomes (ePRO) device from the Screening Visit to the Follow-up Visit (Week 9). The 2 daily assessments was separated by 12 h, at approximately 8 am and at approximately 8 pm. Subjects selected the number that best described the worst itch during the day (assessed at approximately 8 pm) or during the night (
Interventions
- DRUG Placebo
- DRUG Nalfurafine hydrochloride(MT-9938) 2.5μg
- DRUG Nalfurafine hydrochloride(MT-9938) 5μg
- DRUG Nalfurafine hydrochloride(MT-9938) 10μg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-03 |
| Phase | Phase 2 |
Why NCT01660243 stopped before completion
NCT01660243 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01660243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01660243 about?
NCT01660243 is a clinical study titled "Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis". 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 r...
What is the current status of trial NCT01660243?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2012-09. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01660243?
The interventions under investigation include: Placebo (DRUG), Nalfurafine hydrochloride(MT-9938) 2.5μg (DRUG), Nalfurafine hydrochloride(MT-9938) 5μg (DRUG), Nalfurafine hydrochloride(MT-9938) 10μg (DRUG).
Who is sponsoring clinical trial NCT01660243?
This trial is sponsored by Toray Industries, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01660243's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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