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

Sponsor

Kissei Pharmaceutical Co., Ltd. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04711603

Collaborator

(none)

172

Enrollment

Location

Arms

23.5

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uremic Pruritus	Drug: MR13A9 Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

172 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 16, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MR13A9/MR13A9 Patients are administered MR13A9 for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).	Drug: MR13A9 Intravenous administration
Placebo Comparator: Placebo/MR13A9 Patients are administered Placebo for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).	Drug: MR13A9 Intravenous administration Drug: Placebo Intravenous administration

Arm

Intervention/Treatment

Experimental: MR13A9/MR13A9

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

Drug: MR13A9

Intravenous administration

Placebo Comparator: Placebo/MR13A9

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

Drug: MR13A9

Intravenous administration

Drug: Placebo

Intravenous administration

Outcome Measures

Primary Outcome Measures

Change in Numerical Rating Scale (NRS) score of itch [Up to 58 weeks]
Change from baseline in average NRS score of itch

Secondary Outcome Measures

Change in itching scores of Shiratori severity criteria [Up to 58 weeks]
Change from baseline in average itching scores of Shiratori severity criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Multiple Locations		Japan

Sponsors and Collaborators

Kissei Pharmaceutical Co., Ltd.

Investigators

Study Director: Yoshitaka Shimizu, Kissei Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kissei Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04711603

Other Study ID Numbers:

MR13A9-5

First Posted:

Jan 15, 2021

Last Update Posted:

Mar 23, 2022

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pruritus

Study Results

No Results Posted as of Mar 23, 2022