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

Study Description

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Brief 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).

Condition or disease	Intervention/treatment	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

Detailed Description:

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	45 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (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
Study Start Date :	September 2012
Actual Primary Completion Date :	March 2014
Actual Study Completion Date :	March 2014

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Change from baseline in Worst-itching 11-point Numerical Rating Scale (NRS) [ Time Frame: 2 weeks, 4 weeks and 8 week ]
2. Change from baseline in Worst-itching Visual Analog Scale (VAS) [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]
3. Change from baseline in Itch Severity Score [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]
4. Change from baseline in Sleep quality assessment [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]
5. Change from baseline in Excoriation [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]
6. Change from baseline in QoL assessment [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]
7. Change from baseline in Treatment satisfaction (Patient's Global Impression of Change ) [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]

Secondary Outcome Measures :

1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ]

Eligibility Criteria

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Toray Industries, Inc
ClinicalTrials.gov Identifier:	NCT01660243 History of Changes
Other Study ID Numbers:	MT-9938-A01
First Posted:	August 8, 2012
Last Update Posted:	March 17, 2016
Last Verified:	February 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