Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis
Condition: Uremic Pruritus
MeSH terms: Kidney Failure, Chronic; Pruritus
Intervention: Nalfurafine hydrochloride(MT-9938) 2.5μg; Nalfurafine hydrochloride(MT-9938) 5μg; Nalfurafine hydrochloride(MT-9938) 10μg; Placebo
Intervention description: 2.5 μg (2capsules) once daily for 8 weeks; 5 μg (2capsules) once daily for 8 weeks; 10 μg (2capsules) once daily for 8 weeks; Placebo (2capsules) once daily for 8 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pruritus; Renal dialysis; Receptors, Opioid, kappa; Sleep Disorders; Quality of Life

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).
    

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