Status:
COMPLETED
Safety and Pharmacokinetics of IV CR845 in Hemodialysis Patients, and Its Efficacy in Patients With Uremic Pruritus
Lead Sponsor:
Cara Therapeutics, Inc.
Conditions:
Pruritus
Uremic Pruritus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary purpose of this study is to: * Evaluate the safety and pharmacokinetic profile of repeated doses IV CR845 over one week in patients who are undergoing hemodialysis. (Part A) * This study ...
Detailed Description
Placebo-controlled
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Able to provide written informed consent prior to any study procedures;
- Able to communicate clearly with the Investigator and staff, able to read and understand the study procedures;
- Males or females 18 years of age or older;
- End stage renal disease (ESRD) patients who have been on hemodialysis for at least three months and are currently on hemodialysis:
- At least three times per week (Part A)
- Three times per week (Part B)
- Has a body weight ≤ 135 kg
- Part B: Patient who self-reports daily or near daily pruritus during the 6 weeks prior to Screening;
- Part B: Patient who reports a Patient B or Patient C profile on the Patient Self-categorization of Pruritus Disease Severity questionnaire at Screening;
- Part B: At the end of the Run-in Period:
- Patient who completed ratings of worst itching intensity \[visual analog scale (VAS)\] at least 8 times out of 14 VAS assessments;
- Patient who has a mean value of \>40 mm on the worst itching VAS over the one week Run-in Period.
- Exclusion criteria:
- Known to be non-compliant with dialysis treatment (i.e., has a history of missed dialysis sessions due to non-compliance in the past 2 months);
- Anticipated to receive a kidney transplant during the study;
- Known history of allergic reaction to opiates such as hives (Note: side effects related to the use of opioids such as constipation or nausea would not exclude the patients from the study);
- Known or suspected history of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)-diagnosed alcohol, narcotic, or other drug abuse or dependence within 12 months prior to Screening;
- Acute or unstable medical condition(s) such as congestive heart failure \[New York Heart Association (NYHA) class IV\], which in the opinion of the Investigator would pose undue risk to the patient or would impede complete collection of the data or its evaluability;
- Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 2.5X the reference upper limit of normal (ULN), or bilirubin greater than 4X the ULN at Screening;
- Received another investigational drug within 30 days prior to the start of the Run-in Period or has planned to participate in another clinical trial while enrolled in this study
- Part B: Has pruritus probably or definitely attributed to a cause other than ESRD or its complications (e.g., patients with concomitant pruritic dermatological disease or cholestatic liver disease would be excluded). (Note: Patients whose pruritus is attributed to ESRD complications such as hyperparathyroidism, hyperphosphatemia, anemia, or the dialysis procedure or prescription may be enrolled);
- Part B: Has localized itch restricted to the palms of the hands as determined from the Brief Itch Inventory diagram, completed during the Screening Period;
- Part B: Has pruritus only during the dialysis session (by patient report);
- Part B: Has used gabapentin, calcineurin inhibitors, opioids; antipsychotics; systemic or topical corticosteroids (other than otic or ophthalmic preparations); sedatives; hypnotics; anti-anxiety agents selective serotonin reuptake inhibitors (SSRIs); or tricyclic antidepressants for \< 4 weeks prior to the start of the Run-In Period or had a dose change within the previous 30 days;
- Part B: Is not willing to abstain from use of antihistamines (oral, IV, or topical) for 3 weeks (from the start of the Run-In Period through the end of Week 2);
- Part B: Not willing to abstain from making changes to topical non-drug treatments (e.g., emollients, creams, oils) for pruritus for 3 weeks (from the start of the Run-In Period through the end of Week 2);
- Part B: Received ultraviolet B treatment within 30 days prior to the start of the Run-in Period.
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT02229929
Start Date
July 1 2014
End Date
July 1 2015
Last Update
August 10 2016
Active Locations (20)
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1
US Renal Care
Pine Bluff, Arkansas, United States, 71603
2
US Renal Care
Chula Vista, California, United States, 91915
3
US Renal Care
Long Beach, California, United States, 90806
4
Valley Renal Medical Group
Northridge, California, United States, 91324