A Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus

Sanwa Kagaku Kenkyusho

Status and phase: Completed; Phase 2

Conditions: Uremic Pruritus in Hemodialysis Patients

Treatments: Drug: Placebo; Drug: SK-1405 low dose; Drug: SK-1405 high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT03218501

MO1003

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety and dose response of SK-1405 for the treatment of subjects with uremic pruritus receiving hemodialysis, during 2 weeks of treatment.

Enrollment: 269 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Receiving hemodialysis three times a week for at least 12 weeks
• Worst itching VAS in a day is 30 mm or more at least 5 days during the first observation period
• Mean worst itching VAS is 50 mm or more in both the first and second observation periods

Exclusion criteria

• Complications that may affect the assessment of uremic pruritus
• Started or changed pruritus treatment within 13 days prior to starting observations
• Received ultraviolet treatment within 27 days prior to starting observations
• Uncontrollable hypertension, serious liver disease, serious heart disease, stroke, or malignant tumor
• Depression, schizophrenia, dementia, epilepsia, convulsive seizure, drug addiction, or alcoholism
• Pregnancy, or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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269 participants in 3 patient groups, including a placebo group

SK-1405 high dose

Active Comparator group

Description:

SK-1405 high dose is to be administered orally once daily for 2 weeks

Treatment:

Drug: SK-1405 high dose

SK-1405 low dose

Active Comparator group

Description:

SK-1405 low dose is to be administered orally once daily for 2 weeks

Treatment:

Drug: SK-1405 low dose

Placebo

Placebo Comparator group

Description:

Placebo is to be administered orally once daily for 2 weeks

Treatment:

Drug: Placebo