A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

Uremic Pruritus Clinical Trial

Official title:

A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711603
• Other study ID #: MR13A9-5
• Status: Completed
• Phase: Phase 3
• Start date: January 16, 2021
• Est. completion date: September 26, 2022

Study information

• Verified date: April 2023
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Double-blind, Placebo-controlled study to confirm the superiority of MR13A9 to placebo, and followed by extension, open-label treatment to confirm long-term safety of MA13A9 in hemodialysis patients with pruritus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: September 26, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion 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

Exclusion 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 Conditions & MeSH terms

• Pruritus
• Uremic Pruritus

Intervention

Drug:
• MR13A9
Intravenous administration
• Placebo
Intravenous administration

Locations

Country	Name	City	State
Japan	Research Site	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean itch Numerical Rating Scale (NRS) score at week 4	The most severe itching within the day will be recorded in integers on a scale ranging from 0 to 10, where 0 represents no itching and 10 represents worst itching imaginable.	Up to 58 weeks
Secondary	Change from baseline in mean itch NRS score	The most severe itching within the day will be recorded in integers on a scale ranging from 0 to 10, where 0 represents no itching and 10 represents worst itching imaginable.	Up to 58 weeks
Secondary	Change from baseline in mean itch scores based on the Shiratori severity criteria	The symptoms during the day and the night will be recorded on a scale ranging from 0 to 4, where 0 represents no symptoms and 4 represents severe itching.	Up to 58 weeks
Secondary	Percentage of subjects with 3-point improvement in mean itch NRS score	Percentage of subjects with 3-point improvement whose change from baseline in mean itch NRS score is = -3	Up to 58 weeks
Secondary	Percentage of subjects with 4-point improvement in mean itch NRS score	Percentage of subjects with 4-point improvement whose change from baseline in mean itch NRS score is = -4	Up to 58 weeks
Secondary	Change from baseline in Skindex-16 score	The frequency of bothered by itching will be recorded based on scale ranging from 0 to 6, where 0 represents never bothered and 6 represents always bothered.	Week 4, 10, 18, 26, 34, 46, 58
Secondary	Change from baseline in 5-D itch scale score	Five components of condition of itching (duration, degree, direction, disability, distribution) will be recorded based on scale ranging from 5 to 25, with higher scores indicating worse itch-related QOL.	Week 4, 10, 18, 26, 34, 46, 58
Secondary	Percentage of subjects with global symptoms in Patient Global Impression of Change (PGIC)	Subjects will record the overall symptom of itching from the screening period based on a 7-level scale consisting of very much improved, much improved, minimally improved, no change, minimally worsened, much worsened, and very much worsened.	Week 4, 10, 18, 26, 34, 46, 58