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Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
226 participants (actual)
Sponsor
Cara Therapeutics, Inc. · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
Jun 2016
Primary completion
14 Mar 2017
Completion
14 Mar 2017
First posted
8 Aug 2016 (estimated)
Last update posted
29 Jul 2020
Conditions
Uremic Pruritus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 2/3

    Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

    NCT02858726

    Jun 2016 to 14 Mar 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

2 Part Study: Part A will assess 3 different dosing levels of IV CR845 versus placebo in patient on hemodialysis who have moderate-to-severe itching due to uremic pruritus. Patients will receive either CR845 or placebo after each dialysis session for eight weeks. The safety and efficacy of CR845 will be monitored throughout the study. A sub-group of patients will also have pharmacokinetic assessments completed. Part B of the study will assess one dose of IVCR845 versus placebo for 12 weeks in patients on hemodialysis who have moderate-to-severe itching. The dose of CR845 used in Part B will be based on safety and efficacy found in Part A.

Interventions

  • CR845 0.5 mcg/kgDrug
  • CR845 1 mcg/kgDrug
  • CR845 1.5mcg/kgDrug
  • PlaceboDrug

Arms4

  • Experimental

    CR845 0.5mcg/kg

    Part A of study: IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)

  • Experimental

    CR845 1 mcg/kg

    Part A of study: IV CR845 1 mcg/kg administered after each dialysis session (3 times/week)

  • Experimental

    CR845 1.5mcg/kg

    Part A of study: IV CR845 1.5 mcg/kg administered after each dialysis session (3 times/week)

  • Placebo comparator

    Placebo

    Part A of study: IV Placebo administered after each dialysis session (3 times/week)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score During Week 8

    Time frame · Baseline, Week 8

    Registry description

    Intensity of itch was measured using a numerical rating scale (NRS) used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable". Higher scores meant worse itch intensity.

Secondary outcomes(1)
  1. Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in Total Skindex-10 Scale Score at the End of Week 8

    Time frame · Baseline, Week 8

    Registry description

    The Skindex-10 Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past week. The questions cover 3 domains: disease, mood/emotional distress, and social functioning domain. A lower total score represents better quality of life. The minimum score is 0 and the maximum score is 60 (or total score can range from 0 to 60) with a higher score meaning a worse quality of life.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 8

Change From Baseline in the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score During Week 8

GroupValue (score on a scale)Spread
CR845 0.5mcg/kg-3.80.4
CR845 1 mcg/kg-2.80.4
CR845 1.5mcg/kg-3.20.4
Placebo-1.90.4
Secondary and other outcome results(1)
Secondary outcomeLeast squares mean· Baseline, Week 8

Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in Total Skindex-10 Scale Score at the End of Week 8

GroupValue (score on a scale)Spread
CR845 0.5mcg/kg-18.72.0
CR845 1 mcg/kg-15.52.2
CR845 1.5mcg/kg-15.12.3
Placebo-8.22.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
CR845 0.5mcg/kgIV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)1 / 4410 / 4422 / 44
CR845 1 mcg/kgIV CR845 1 mcg/kg administered after each dialysis session (3 times/week)0 / 416 / 4116 / 41
CR845 1.5mcg/kgIV CR845 1.5 mcg/kg administered after each dialysis session (3 times/week)2 / 4411 / 4418 / 44
PlaceboIV Placebo administered after each dialysis session (3 times/week) Placebo: IV medication delivered three times/week1 / 454 / 453 / 45

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedHercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2. PMID 33283264

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Willing and able to provide written informed consent prior to participating in this study; 2. Able to communicate clearly with the Investigator and staff, able to read, complete questionnaires, and understand the study procedures; 3. Males or females 18 years of age or older; 4. ESRD patients who have been on hemodialysis 3 times per week for at least 3 months prior to the start of Screening; 5. Women of child-bearing potential must have a negative serum pregnancy test and agree to practice an acceptable form of birth control for the duration of the study 6. Male patients that are not biologically or surgically sterile must agree to practice an acceptable from of birth control for the duration of the study 7. Weigh between 88.2 lb (40.0 kg) and 297.6 lb (135.0 kg). 8. Patient must self-report pruritus in the month prior to screening. 9. If patient is receiving treatment for itch, this treatment must be stable prior to screening and during treatment period. 10. At least 2 single-pool Kt/V measurements ≥ 1.2, or at least 2 urea reduction ratio measurements ≥ 65%, or 1 single-pool Kt/V measurement ≥ 1.2 and 1 urea reduction ratio measurement ≥ 65% on different dialysis days during the 3 months period prior to Screening; 11. Patient who self-categorize as moderate-to-severe itch. Exclusion Criteria: 1. Known to be non-compliant with dialysis treatment (i.e., has missed more than 2 dialysis sessions in the past 2 months because of non-compliance); 2. Anticipated to receive a kidney transplant during the study; 3. Known history of allergic reaction to opiates, such as hives 4. Known or suspected history of alcohol, narcotic, or other drug abuse or dependence within 12 months prior to Screening; 5. Patient has any clinically relevant acute or chronic medical or neuropsychiatric condition which, in the opinion of the Investigator, would pose undue risk to the patient, would impede completion of the study procedures, or would compromise the validity of the study measurements; 6. Serum alanine aminotransferase or aspartate aminotransferase greater than 2.5 times the reference upper limit of normal (ULN), or total bilirubin greater than 2 times ULN at Screening; 7. Received another investigational drug within 30 days prior to the start of Screening or has planned to participate in another clinical trial while enrolled in this study; 8. 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); 9. Has localized itch restricted to the palms of the hands; 10. Has pruritus only during the dialysis session (by patient report); 11. Anticipated to receive opioid antagonists (e.g., naloxone, naltrexone), or opioid mixed agonist-antagonist (e.g., buprenorphine, nalbuphine) from the start of Screening through the end of the Treatment Period; 12. Used Salvia divinorum or Salvinorin A within 30 days prior to the start of Screening or is anticipated to use it during the study; 13. Received ultraviolet B treatment within 30 days prior to the start of Screening or anticipated to receive such treatment during the study; 14. Participated in a previous clinical trial with CR845.

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