A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

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Kissei

Status and phase

Completed
Phase 2

Conditions

Uremic Pruritus

Treatments

Drug: MR13A9
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03802617
MR13A9-4

Details and patient eligibility

About

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

Enrollment

247 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

247 participants in 4 patient groups, including a placebo group

MR13A9 low dose
Experimental group
Treatment:
Drug: MR13A9
MR13A9 medium dose
Experimental group
Treatment:
Drug: MR13A9
MR13A9 high dose
Experimental group
Treatment:
Drug: MR13A9
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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