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New drug aims to stop the agonizing itch of dialysis

NCT ID NCT04711603

Symptom relief Sponsor: Kissei Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed Phase 3 trial tested a drug called MR13A9 in 178 adults on hemodialysis who suffer from severe itching (uremic pruritus). The study compared MR13A9 to a placebo to see if it reduces itch intensity, measured by a daily 0-10 rating scale. If successful, MR13A9 could become a new treatment option for this distressing symptom.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MR13A9 (a drug given intravenously)
What this could lead to
If it works, this could provide a new option to reduce severe itching in people on hemodialysis.
What could go wrong
This is a single Phase 3 trial with 178 participants. The drug may not work better than placebo, and long-term safety is still being checked.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

178 people

The number who actually took part.

Started

Jan 2021

Finished

Sep 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Uremic pruritus

Contacts and locations

Locations

  • Research Site

    Multiple Locations, Japan

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