CompletedPhase 2

A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

Japan247 participantsStarted 2019-02-01

Plain-language summary

Double-blind, Placebo-controlled study to evaluate the dose-response relationship of safety, efficacy and pharmacokinetics 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: * Japanese with male or female aged ≥ 20 * 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 8 of the Treatment Period

Timeframe: 8 weeks

Trial details

NCT IDNCT03802617

SponsorKissei Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-10-22

Results submitted2025-06-09

View on ClinicalTrials.gov More Uremic Pruritus trials