Trials / Approved For Marketing
Approved For MarketingNCT05031546
Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Cara Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
This is an intermediate-size patient population expanded access protocol for the use of intravenous (IV) difelikefalin for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients undergoing hemodialysis.
Detailed description
Visits during the expanded access program will consist of a Baseline Visit to confirm eligibility and an End of Treatment visit. Patients will receive IV difelikefalin at a dose of 0.5 mcg/kg after each dialysis session, generally 3 times per week. The End of Treatment visit will be defined as the first dialysis visit following the last dose of IV difelikefalin under the intermediate-size patient population expanded access protocol.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Difelikefalin | IV Difelikefalin 0.5 mcg/kg administered after each dialysis session (3 times/week) |
Timeline
- First posted
- 2021-09-02
- Last updated
- 2022-05-18
Source: ClinicalTrials.gov record NCT05031546. Inclusion in this directory is not an endorsement.