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A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802617
Recruitment Status : Active, not recruiting
First Posted : January 14, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
Maruishi Pharmaceutical
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Brief Summary:
Double-blind, Placebo-controlled study to evaluate the dose-response relationship of safety, efficacy and pharmacokinetics of MA13A9 in hemodialysis patients with pruritus.

Condition or disease Intervention/treatment Phase
Uremic Pruritus Drug: MR13A9 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Itching

Arm Intervention/treatment
Experimental: MR13A9 low dose Drug: MR13A9
Intravenous administration

Experimental: MR13A9 medium dose Drug: MR13A9
Intravenous administration

Experimental: MR13A9 high dose Drug: MR13A9
Intravenous administration

Placebo Comparator: Placebo Drug: Placebo
Intravenous administration




Primary Outcome Measures :
  1. Change in Numerical Rating Scale (NRS) score of itch [ Time Frame: 8 weeks ]
    Change from baseline in average NRS score of itch at week 8


Secondary Outcome Measures :
  1. Change in itching scores of Shiratori severity criteria [ Time Frame: 8 weeks ]
    Change from baseline in average itching scores of Shiratori severity criteria at week 8



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802617


Locations
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Japan
Research Site
Multiple Locations, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Maruishi Pharmaceutical
Investigators
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Study Director: Nobuo Kanai Clinical Development Div.
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Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03802617    
Other Study ID Numbers: MR13A9-4
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations