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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Overview

Status
Completed
Phase
Phase 3
Enrollment
288 participants (actual)
Sponsor
Cara Therapeutics, Inc. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
2 countries

United States, Puerto Rico

Start
14 Aug 2017
Primary completion
11 Feb 2020
Completion
11 Feb 2020
First posted
13 Sept 2017
Last update posted
14 Oct 2021
Conditions
Uremic Pruritus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20172018201920202021
  1. Ph 3

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

    NCT03281538

    14 Aug 2017 to 11 Feb 2020

Registry summary

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

This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks.

Interventions

  • CR845Drug

Arms1

  • Experimental

    CR845 0.5mcg/kg

    CR845 0.5mcg/kg IV medication administered three times/week after dialysis

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With AEs

    Time frame · Up to 52 weeks

    Registry description

    Assessed by physical examination, monitoring of adverse events, vital signs and laboratory assessments

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 outcomeCount of participants· Up to 52 weeks

Number of Participants With AEs

GroupValue (Participants)
CR845 0.5mcg/kg240

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
CR845 0.5mcg/kgCR845 0.5mcg/kg IV medication administered three times/week after dialysis CR845: IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)17 / 288148 / 288139 / 288

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2022

14 results

Safety and Tolerability of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis From the Phase 3 Clinical Trial Program.

Fishbane et al. 2022Kidney medicinecited by 38

PMID 36039153PMC9418597DOI 10.1016/j.xkme.2022.100513PUB-36039153

Free to read · publisher termsCC BY-NC-ND14 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: To be eligible for inclusion into the study, a patient must meet the following 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 understand the study procedures, and able and willing to comply with the study schedules and all study requirements; 3. Males or females 18 years of age or older; 4. Currently on hemodialysis for end-stage renal disease and has been categorized as experiencing moderate to severe uremic pruritus; 5. If female: 1. Is not of childbearing potential (surgically sterile or postmenopausal, as defined in Section 6.5.1.6); or 2. Has a negative serum pregnancy test at screening and agrees to use acceptable contraceptive measures (as defined in Section 6.5.1.6) from the time of informed consent until the safety Follow-up Visit or 7 days after the last dose of study drug, whichever is later. 6. If male, agrees not to donate sperm after the first dose of study drug until 7 days after the last dose, and agrees to use a condom with spermicide or abstain from heterosexual intercourse during the study until 7 days after study drug administration. (Note: No restrictions are required for a vasectomized male provided his vasectomy was performed ≥4 months prior to dosing); 7. Has a dry body weight of ≥40.0 kg at screening (prescription target dry body weight); 8. Has adequacy of dialysis, defined as meeting 1 of the following criteria during the 3 months prior to screening: 1. ≥2 single pool Kt/V measurements ≥1.2; or 2. ≥2 urea reduction ratio measurements ≥65%; or 3. 1 single pool Kt/V measurement ≥1.2 and 1 urea reduction ratio measurement ≥65% Exclusion Criteria: A patient will be excluded from the study if any of the following criteria are met: 1. Received an investigational drugwithin 30 days prior to the first dose of study drug, or is planning to participate in another interventional clinical study while enrolled in this study. 2. Has a concomitant disease or any medical condition that, in the opinion of the Investigator, could pose undue risk to the patient, impede completion of the study procedures, or would compromise the validity of the study measurements, including, but not limited to: 1. Known or suspected history of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, -diagnosed alcohol, narcotic or other drug abuse, or substance dependence within 12 months prior to screening; 2. New York Heart Association Class IV congestive heart failure (Appendix 1, Section 14.0); 3. Severe mental illness or cognitive impairment (eg, dementia); 4. Any other relevant acute or chronic medical or neuropsychiatric condition;

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