Phase 3
N=178
A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Uremic Pruritus
Bottom Line
View on ClinicalTrials.gov: NCT04711603 ↗Enrolled (actual)
178
Serious AEs
25.4%
Results posted
Sep 2025
Primary outcome: Primary: Change From Baseline in the Mean NRS Score at Week 4 — -2.06; -1.09 points — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MR13A9 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Mean NRS Score at Week 4 |
-2.06; -1.09 | <0.001 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04711603). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.