Back to results

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

Primary Purpose

Uremic Pruritus

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

MR13A9

Placebo

About this trial

This is an interventional treatment trial for Uremic Pruritus

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MR13A9/MR13A9

Placebo/MR13A9

Arm Description

Patients are administered MR13A9 for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).

Patients are administered Placebo for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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

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

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.

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.

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.

Full Information

NCT ID

NCT04711603

First Posted

January 13, 2021

Last Updated

July 13, 2023

Sponsor

Kissei Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04711603

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

January 16, 2021 (Actual)

Primary Completion Date

January 25, 2022 (Actual)

Study Completion Date

September 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kissei Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uremic Pruritus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

178 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MR13A9/MR13A9

Arm Type

Experimental

Arm Description

Patients are administered MR13A9 for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).

Arm Title

Placebo/MR13A9

Arm Type

Placebo Comparator

Arm Description

Patients are administered Placebo for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).

Intervention Type

Drug

Intervention Name(s)

MR13A9

Intervention Description

Intravenous administration

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intravenous administration

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Up to 58 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in mean itch NRS score

Description

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.

Time Frame

Up to 58 weeks

Title

Change from baseline in mean itch scores based on the Shiratori severity criteria

Description

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.

Time Frame

Up to 58 weeks

Title

Percentage of subjects with 3-point improvement in mean itch NRS score

Description

Percentage of subjects with 3-point improvement whose change from baseline in mean itch NRS score is ≤ -3

Time Frame

Up to 58 weeks

Title

Percentage of subjects with 4-point improvement in mean itch NRS score

Description

Percentage of subjects with 4-point improvement whose change from baseline in mean itch NRS score is ≤ -4

Time Frame

Up to 58 weeks

Title

Change from baseline in Skindex-16 score

Description

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.

Time Frame

Week 4, 10, 18, 26, 34, 46, 58

Title

Change from baseline in 5-D itch scale score

Description

Time Frame

Week 4, 10, 18, 26, 34, 46, 58

Title

Percentage of subjects with global symptoms in Patient Global Impression of Change (PGIC)

Description

Time Frame

Week 4, 10, 18, 26, 34, 46, 58

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoshitaka Shimizu

Organizational Affiliation

Kissei Pharmaceutical Co., Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Multiple Locations

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs