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

NCT ID: NCT01660243

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-03-31

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).

Detailed Description

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

Conditions

Uremic Pruritus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MT-9938 2.5μg

Group Type: ACTIVE_COMPARATOR

Nalfurafine hydrochloride(MT-9938) 2.5μg

Intervention Type: DRUG

2.5 μg (2capsules) once daily for 8 weeks

MT-9938 5μg

Group Type: ACTIVE_COMPARATOR

Nalfurafine hydrochloride(MT-9938) 5μg

Intervention Type: DRUG

5 μg (2capsules) once daily for 8 weeks

MT-9938 10μg

Group Type: ACTIVE_COMPARATOR

Nalfurafine hydrochloride(MT-9938) 10μg

Intervention Type: DRUG

10 μg (2capsules) once daily for 8 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (2capsules) once daily for 8 weeks

Interventions

Nalfurafine hydrochloride(MT-9938) 2.5μg

2.5 μg (2capsules) once daily for 8 weeks

Intervention Type: DRUG

Nalfurafine hydrochloride(MT-9938) 5μg

5 μg (2capsules) once daily for 8 weeks

Intervention Type: DRUG

Nalfurafine hydrochloride(MT-9938) 10μg

10 μg (2capsules) once daily for 8 weeks

Intervention Type: DRUG

Placebo

Placebo (2capsules) once daily for 8 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Toray Industries, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Los Angeles, California, United States

New York, New York, United States

Rosedale, New York, United States

San Antonio, Texas, United States

Countries

United States

References

Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.

Reference Type: DERIVED

PMID: 33283264 (View on PubMed)

Other Identifiers

MT-9938-A01

Identifier Type: -

Identifier Source: org_study_id