Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

Trevi Therapeutics

Status and phase: Completed; Phase 3; Phase 2

Conditions: Uremic Pruritus; Pruritus

Treatments: Drug: nalbuphine HCl ER tablets 120mg BID; Drug: nalbuphine HCl ER tablets 60 mg BID; Drug: Placebo tablets BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT02143648

TR02

2013-005625-22 (EudraCT Number)

Details and patient eligibility

About

The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and tolerability in the study population.

Enrollment: 373 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has been receiving in-center hemodialysis for ≥ 3 months and are currently on a schedule of 3 times a week.
• Subject self-categorized themselves on the Patient Assessed Disease Severity Scale during Screening
• Subject meets standard of care hemodialysis efficiency guidelines during the three months prior to completing Screening
• Have demonstrated pruritus intensity on the Itch NRS during screening
• Male or female who are at least 18 years old at the time of Screening

Exclusion criteria

• Subject had a significant alteration in dialysis regimen during the Screening Period
• Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study.
• Subject has pruritus that is believed to be caused by a condition unrelated to end-stage renal disease
• Has had a history of substance abuse within 6 months prior to completing Screening
• Subject has a known drug allergy to opioids
• Subject is a pregnant or lactating female.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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373 participants in 3 patient groups, including a placebo group

nalbuphine HCl ER 60mg

Experimental group

Description:

nalbuphine HCl ER tablets 60 mg BID

Treatment:

Drug: nalbuphine HCl ER tablets 60 mg BID

nalbuphine HCl ER 120mg

Experimental group

Description:

nalbuphine HCl ER tablets 120 mg BID

Treatment:

Drug: nalbuphine HCl ER tablets 120mg BID

Sugar pill

Placebo Comparator group

Description:

Placebo tablets BID

Treatment:

Drug: Placebo tablets BID