Back to resultsIntermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin
Primary Purpose
Uremic Pruritus
Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Difelikefalin
Sponsored by
About this trial
This is an expanded access trial for Uremic Pruritus focused on measuring Hemodialysis, Pruritus, Uremic Pruritus, Dialysis, CR845, Difelikefalin, Chronic Itch, CKD, CKD-associated pruritus, CKD-aP, ESRD (end stage renal disease), Itch, Itching, KALM, Chronic Kidney Disease, Kidney failure, chronic, Kidney dysfunction, Generalized pruritus, Expanded access, Compassionate use
Eligibility Criteria
Key Inclusion Criteria:
- Adults ≥ 18 years old;
- Has end-stage renal disease (ESRD) and is currently receiving in-center hemodialysis;
- Has moderate-to-severe pruritus attributed to ESRD which is significantly impacting the patient's quality of life;
- Has no comparable or satisfactory alternative therapy for the treatment of moderate-to-severe pruritus, as determined by the sponsor-investigator.
Key Exclusion Criteria:
- Has severe hepatic impairment (Child-Pugh class C), as the influence of severe hepatic impairment on the pharmacokinetics of difelikefalin has not been evaluated;
- Is pregnant or nursing;
- Has been exposed to any other investigational medication in the past 60 days;
- Present any other reason which may lead to an unfavorable risk-benefit ratio for treatment with difelikefalin, as determined by the sponsor-investigator;
- Has a known or suspected allergy to difelikefalin or any component of the investigational product.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05031546
Brief Title
Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin
Official Title
Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin
Study Type
Expanded Access
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cara Therapeutics, Inc.
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremic Pruritus
Keywords
Hemodialysis, Pruritus, Uremic Pruritus, Dialysis, CR845, Difelikefalin, Chronic Itch, CKD, CKD-associated pruritus, CKD-aP, ESRD (end stage renal disease), Itch, Itching, KALM, Chronic Kidney Disease, Kidney failure, chronic, Kidney dysfunction, Generalized pruritus, Expanded access, Compassionate use
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Difelikefalin
Intervention Description
IV Difelikefalin 0.5 mcg/kg administered after each dialysis session (3 times/week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Key Inclusion Criteria:
Adults ≥ 18 years old;
Has end-stage renal disease (ESRD) and is currently receiving in-center hemodialysis;
Has moderate-to-severe pruritus attributed to ESRD which is significantly impacting the patient's quality of life;
Has no comparable or satisfactory alternative therapy for the treatment of moderate-to-severe pruritus, as determined by the sponsor-investigator.
Key Exclusion Criteria:
Has severe hepatic impairment (Child-Pugh class C), as the influence of severe hepatic impairment on the pharmacokinetics of difelikefalin has not been evaluated;
Is pregnant or nursing;
Has been exposed to any other investigational medication in the past 60 days;
Present any other reason which may lead to an unfavorable risk-benefit ratio for treatment with difelikefalin, as determined by the sponsor-investigator;
Has a known or suspected allergy to difelikefalin or any component of the investigational product.
12. IPD Sharing Statement
Learn more about this trial
Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin
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