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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-16

Study Completion Date

2022-09-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Uremic Pruritus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MR13A9/MR13A9

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

Group Type EXPERIMENTAL

MR13A9

Intervention Type DRUG

Intravenous administration

Placebo/MR13A9

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

Group Type PLACEBO_COMPARATOR

MR13A9

Intervention Type DRUG

Intravenous administration

Placebo

Intervention Type DRUG

Intravenous administration

Interventions

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MR13A9

Intravenous administration

Intervention Type DRUG

Placebo

Intravenous administration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No