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Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis
This study has been terminated.
(This study has been terminated because of insufficient patient recruitment.)
Sponsor:
Toray Industries, Inc
Information provided by (Responsible Party):
Toray Industries, Inc
ClinicalTrials.gov Identifier:
NCT01660243
First received: August 2, 2012
Last updated: February 18, 2016
Last verified: February 2016
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
| Uremic Pruritus | Drug: Nalfurafine hydrochloride(MT-9938) 2.5μg Drug: Nalfurafine hydrochloride(MT-9938) 5μg Drug: Nalfurafine hydrochloride(MT-9938) 10μg Drug: Placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Toray Industries, Inc:
Primary Outcome Measures:
- Change from baseline in Worst-itching 11-point Numerical Rating Scale (NRS) [ Time Frame: 2 weeks, 4 weeks and 8 week ]
- Change from baseline in Worst-itching Visual Analog Scale (VAS) [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]
- Change from baseline in Itch Severity Score [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]
- Change from baseline in Sleep quality assessment [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]
- Change from baseline in Excoriation [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]
- Change from baseline in QoL assessment [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]
- Change from baseline in Treatment satisfaction (Patient's Global Impression of Change ) [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]
Secondary Outcome Measures:
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ]
| Enrollment: | 45 |
| Study Start Date: | September 2012 |
| Study Completion Date: | March 2014 |
| Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: MT-9938 2.5μg |
Drug: Nalfurafine hydrochloride(MT-9938) 2.5μg
2.5 μg (2capsules) once daily for 8 weeks
|
| Active Comparator: MT-9938 5μg |
Drug: Nalfurafine hydrochloride(MT-9938) 5μg
5 μg (2capsules) once daily for 8 weeks
|
| Active Comparator: MT-9938 10μg |
Drug: Nalfurafine hydrochloride(MT-9938) 10μg
10 μg (2capsules) once daily for 8 weeks
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo (2capsules) once daily for 8 weeks
|
Detailed Description:
This study has been terminated because of insufficient patient recruitment. There were no safety concerns.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- On stable hemodialysis for at least 3 months
- Has stable functioning arteriovenous fistula, graft or other venous access
- Has continued (uncontrolled) uremic pruritus despite standard of care in the institution
- Has severe pruritus, as determined by a qualifying score of ≥3 on the Itch Severity Score Scale (0 to 4) either day or night during the week prior to Screening Visit
- Has no known drug addiction to any prescription, nonprescription, herbal or natural drugs, and successfully passes a drug screen test
- Women and men whose partners are of childbearing potential agree to practice the medically acceptable methods of birth control and agree to continue with the regimen throughout the duration of the study
- Capable of understanding and responding to the subject questionnaires, understands the purpose and risks of the study, and has given written informed consent
- Has rated his/her NRS score each day for at least 5 days out of the 7 days of the Run-in Phase
- Has severe pruritus, as determined by qualifying mean worst NRS score in a day of ≥5 (on 11 point NRS) at the end of the 1-week Run-in Phase
Exclusion Criteria:
- Current, clinically significant medical comorbidities
- Abnormal liver dysfunction
- Pruritus attributed mainly to any disease unrelated to kidney disease
- Calcium x phosphorus product >80 mg2/dL2 or hemoglobin <7 g/dL or parathyroid hormone levels >1000 pg/mL at Screening
- Received ultraviolet B treatment within 30 days prior to Screening
- Started or changed psychotropic medication within 14 days prior to Screening
- Is receiving opioid antagonists or opioid agonists within 7 days prior to Screening and not willing to abstain from these medications during the study.
- Started or changed medications, creams or emollients including over-the-counter oil bath treatment for relief of pruritus within 7 days prior to Screening
- Has known hypersensitivity to opioids or the study drug ingredients
- Is currently participating in an investigational drug or device clinical study or was participating in such a study within 30 days prior to the start of Screening
- Female subject who is known to be pregnant or nursing
- Is considered not suitable for inclusion in the study in the opinion of Investigator
- Has current suicidal ideation with some intent to act or with specific plan and intent or had suicidal behavior at any time in subject's life
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01660243
Please refer to this study by its ClinicalTrials.gov identifier: NCT01660243
Locations
| United States, California | |
| Los Angeles, California, United States | |
| United States, New York | |
| New York, New York, United States | |
| Rosedale, New York, United States | |
| United States, Texas | |
| San Antonio, Texas, United States | |
Sponsors and Collaborators
Toray Industries, Inc
More Information
| Responsible Party: | Toray Industries, Inc |
| ClinicalTrials.gov Identifier: | NCT01660243 History of Changes |
| Other Study ID Numbers: |
MT-9938-A01 |
| Study First Received: | August 2, 2012 |
| Last Updated: | February 18, 2016 |
Keywords provided by Toray Industries, Inc:
|
Pruritus Renal dialysis Receptors, Opioid, kappa Sleep Disorders Quality of Life |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Pruritus Urologic Diseases Renal Insufficiency, Chronic |
Renal Insufficiency Skin Diseases Skin Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on July 28, 2017