CompletedPhase 3

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

Japan178 participantsStarted 2021-01-16

Plain-language 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.

Who can participate

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change From Baseline in the Mean NRS Score at Week 4

Timeframe: 4 weeks

Trial details

NCT IDNCT04711603

SponsorKissei Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-25

Results submitted2025-06-09

View on ClinicalTrials.gov More Uremic Pruritus trials