Phase 2 Study of MR13A9.

Phase 2 Study to Evaluate Efficacy and Safety of MR13A9 in Hemodialysis Patients with Uremic Pruritus.

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223210

Enrollment

100

Registered

2016-05-23

Start date

2016-05-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis patients with uremic pruritus.

Interventions

investigational material(s) Generic name etc : MR13A9 INN of investigational material : Difelikefalin Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with chronic renal failure who regularly receive hemodialysis three times weekly. (2) Patients who have treated with systemic therapy and topical therapy for itching and not adequately responded to either of them. (3) Patients who are treating with one or more of the drugs for iching. (4) Patients with a mean VAS (Visual Analogue Scale) score of >= 50mm.

Exclusion criteria

Exclusion criteria: Patients who are judged to be inadequate for this study participation by the investigator or the subinvestigator.

Design outcomes

Primary

Measure	Time frame
Iching visual analogue scale.	—

Secondary

Measure	Time frame
Shiratori's severity criteria etc.	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026