A phase III clinical study of MR13A9 in hemodialysis patients with pruritus

JRCT ID: jRCT2011200021

Registered date:29/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Uremic Pruritus
• Date of first enrollment: 16/01/2021
• Target sample size: 172
• Study type: Interventional
• Intervention(s): Intravenous administration of MR13A9 or Placebo

Outcome(s)

• Primary Outcome: Change from baseline in mean itch Numerical Rating Scale (NRS) score at week 4

Secondary Outcome

- Change from baseline in mean itch Numerical Rating Scale (NRS) score
- Change from baseline in mean itch scores based on the Shiratori severity criteria
- Percentage of subjects with 3-point improvement in mean itch NRS score
- Percentage of subjects with 4-point improvement in mean itch NRS score
- Change from baseline in Skindex-16 score
- Change from baseline in 5-D itch scale score
- Percentage of subjects with global symptoms in Patient Global Impression of Change (PGIC)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Patient with Chronic Kidney Disease (CKD) has been on hemodialysis 3 times per week
- Patient receiving treatment for itch
- Patient has a baseline NRS score > 4

Exclude criteria

- Patient has pruritus cause other than CKD or its complications
- Patients has hepatic cirrhosis
- Patient has a known history of allergic reaction to opiates

Related Information

• Primary Sponsor: Shimizu Yoshitaka
• Secondary ID(s): NCT04711603