Pruritus, Uremic Pruritus
Conditions
Keywords
uremic, pruritus, itch, chronic itch, nalbuphine
Brief summary
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.
Interventions
DRUGnalbuphine HCl ER tablets 60 mg BID
nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks
DRUGnalbuphine HCl ER tablets 120mg BID
nalbuphine HCl ER tablets 120mg BID administered for 6 weeks
Placebo tablets BID administered for 8 weeks
Sponsors
Trevi Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale | 8 weeks | The evaluation period was defined as the average itch score over weeks 7 and 8 following initiation of treatment. A negative change form baseline (Evaluation Period - Baseline) signified inmprovement. |
Countries
Poland, Romania, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nalbuphine HCl ER 60mg nalbuphine HCl ER tablets 60 mg BID
nalbuphine HCl ER tablets 60 mg BID: nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks | 126 |
| Nalbuphine HCl ER 120mg nalbuphine HCl ER tablets 120 mg BID
nalbuphine HCl ER tablets 120mg BID: nalbuphine HCl ER tablets 120mg BID administered for 6 weeks | 120 |
| Sugar Pill Placebo tablets BID
Placebo tablets BID: Placebo tablets BID administered for 8 weeks | 123 |
| Total | 369 |
Baseline characteristics
| Characteristic | Nalbuphine HCl ER 60mg | Total | Sugar Pill | Nalbuphine HCl ER 120mg |
|---|---|---|---|---|
| Age, Continuous | 55.0 years STANDARD_DEVIATION 12.1 | 55.6 years STANDARD_DEVIATION 12.4 | 56.5 years STANDARD_DEVIATION 13 | 55.2 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 61 Participants | 18 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants | 308 Participants | 105 Participants | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 6 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 66 Participants | 181 Participants | 60 Participants | 55 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 57 Participants | 178 Participants | 59 Participants | 62 Participants |
| Region of Enrollment Europe | 23 participants | 69 participants | 23 participants | 23 participants |
| Region of Enrollment United States | 103 participants | 300 participants | 100 participants | 97 participants |
| Sex: Female, Male Female | 58 Participants | 158 Participants | 49 Participants | 51 Participants |
| Sex: Female, Male Male | 68 Participants | 211 Participants | 74 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 126 | 0 / 120 | 0 / 123 |
| other Total, other adverse events | 0 / 126 | 0 / 120 | 0 / 123 |
| serious Total, serious adverse events | 16 / 126 | 8 / 120 | 19 / 123 |
Outcome results
Primary
Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale
The evaluation period was defined as the average itch score over weeks 7 and 8 following initiation of treatment. A negative change form baseline (Evaluation Period - Baseline) signified inmprovement.
Time frame: 8 weeks
Population: The sample sizes for each arm include participants who had a baseline value and at least one post baseline value for the average itch score during teh Evaluation Period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Nalbuphine HCl ER 60mg | Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale | -3.10 units on a scale | Standard Deviation 2.35 |
| Nalbuphine HCl ER 120mg | Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale | -3.49 units on a scale | Standard Deviation 2.37 |
| Sugar Pill | Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale | -2.80 units on a scale | Standard Deviation 2.22 |