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

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Dialysis Itching Kidney Failure

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
Change from baseline in Worst-itching Visual Analog Scale (VAS) [ Time Frame: 2 weeks, 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in Itch Severity Score [ Time Frame: 2 weeks, 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in Sleep quality assessment [ Time Frame: 2 weeks, 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in Excoriation [ Time Frame: 2 weeks, 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in QoL assessment [ Time Frame: 2 weeks, 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in Treatment satisfaction (Patient's Global Impression of Change ) [ Time Frame: 2 weeks, 4 weeks and 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]


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)
Genders Eligible for Study:	Both
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

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
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

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 September 23, 2016