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Clinical trial

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

ID
Name
MR13A9-5
Description
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.
Trial arms
Trial start
2021-01-16
Estimated PCD
2022-01-25
Trial end
2022-09-26
Status
Completed
Phase
Early phase I
Treatment
MR13A9
Intravenous administration
Arms:
MR13A9/MR13A9, Placebo/MR13A9
Placebo
Intravenous administration
Arms:
Placebo/MR13A9
Size
178
Primary endpoint
Change from baseline in mean itch Numerical Rating Scale (NRS) score at week 4
Up to 58 weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 178, 'type': 'ACTUAL'}}
Updated at
2023-07-17

1 organization

2 products

1 indication

Organization
Kissei Pharmaceutical
Product
Placebo
Indication
Uremic Pruritus
Product
MR13A9