Phase 2
N=247
A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Uremic Pruritus
Bottom Line
View on ClinicalTrials.gov: NCT03802617 ↗Enrolled (actual)
247
Serious AEs
7.3%
Results posted
Dec 2025
Primary outcome: Primary: Change From Baseline in the Mean NRS Score at Week 8 of the Treatment Period — -2.97; -3.65; -3.64; -2.86 points — p=0.770
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MR13A9 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Mean NRS Score at Week 8 of the Treatment Period |
-2.97; -3.65; -3.64; -2.86 | 0.770 |
Summary
Double-blind, Placebo-controlled study to evaluate the dose-response relationship of safety, efficacy and pharmacokinetics of MA13A9 in hemodialysis patients with pruritus.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03802617). 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.