Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
An Open-Label, Multicenter, Extension Study to Evaluate the Long Term Safety of Intravenous CR845 in Hemodialysis Patients With Chronic Kidney Disease-Associated Pruritus
1 other identifier
interventional
288
2 countries
27
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2017
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2017
CompletedStudy Start
First participant enrolled
August 14, 2017
CompletedFirst Posted
Study publicly available on registry
September 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2020
CompletedResults Posted
Study results publicly available
October 14, 2021
CompletedOctober 14, 2021
September 1, 2021
2.5 years
June 20, 2017
September 21, 2021
September 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With AEs
Assessed by physical examination, monitoring of adverse events, vital signs and laboratory assessments
Up to 52 weeks
Study Arms (1)
CR845 0.5mcg/kg
EXPERIMENTALCR845 0.5mcg/kg IV medication administered three times/week after dialysis
Interventions
Eligibility Criteria
You may qualify if:
- Willing and able to provide written informed consent prior to participating in this study;
- 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;
- Males or females 18 years of age or older;
- Currently on hemodialysis for end-stage renal disease and has been categorized as experiencing moderate to severe uremic pruritus;
- If female:
- Is not of childbearing potential (surgically sterile or postmenopausal, as defined in Section 6.5.1.6); or
- 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.
- 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);
- Has a dry body weight of ≥40.0 kg at screening (prescription target dry body weight);
- Has adequacy of dialysis, defined as meeting 1 of the following criteria during the 3 months prior to screening:
- ≥2 single pool Kt/V measurements ≥1.2; or
- ≥2 urea reduction ratio measurements ≥65%; or
- single pool Kt/V measurement ≥1.2 and 1 urea reduction ratio measurement ≥65%
You may not qualify if:
- A patient will be excluded from the study if any of the following criteria are met:
- 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.
- 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:
- 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;
- New York Heart Association Class IV congestive heart failure (Appendix 1, Section 14.0);
- Severe mental illness or cognitive impairment (eg, dementia);
- Any other relevant acute or chronic medical or neuropsychiatric condition;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Cara Therapeutics Study Site
Chula Vista, California, 91990, United States
Cara Therapeutics Study Site
El Centro, California, 92243, United States
Cara Therapeutics Study Site
Long Beach, California, 90813, United States
Cara Therapeutics Study Site
Northridge, California, 91324, United States
Cara Therapeutics Study Site
Denver, Colorado, 80230, United States
Cara Therapeutics Study Site
Hollywood, Florida, 33024, United States
Cara Therapeutics Study Site
Tampa, Florida, 33614, United States
Cara Therapeutics Study Site
Winter Park, Florida, 32789, United States
Cara Therapeutics Study Site
Albany, Georgia, 31701, United States
Cara Therapeutics Study Site
Augusta, Georgia, 30909, United States
Cara Therapeutics Study Site
Meridian, Idaho, 83642, United States
Cara Therapeutics Study Site
Springfield, Massachusetts, 01107, United States
Cara Therapeutics Study Site
Roseville, Michigan, 48066, United States
Cara Therapeutics Study Site
Kansas City, Missouri, 64131, United States
Cara Therapeutics Study Site
Albuquerque, New Mexico, 87109, United States
Cara Therapeutics Study Site
Gallup, New Mexico, 87301, United States
Cara Therapeutics Study Site
Mineola, New York, 11501, United States
Cara Therapeutics Study Site
Ridgewood, New York, 11385, United States
Cara Therapeutics Study Site
Bethlehem, Pennsylvania, 18017, United States
Cara Therapeutics Study Site
Knoxville, Tennessee, 37920, United States
Cara Therapeutics Study Site
El Paso, Texas, 79902, United States
Cara Therapeutics Study Site
San Antonio, Texas, 78202, United States
Cara Therapeutics Study Site
San Antonio, Texas, 78221, United States
Cara Therapeutics Study Site
San Antonio, Texas, 78229, United States
Cara Therapeutics Study Site
St. George, Utah, 84790, United States
Cara Therapeutics Study Site
Wauwatosa, Wisconsin, 53326, United States
Cara Therapeutics Study Site
San Juan, 00926, Puerto Rico
Related Publications (1)
Fishbane S, Wen W, Munera C, Lin R, Bagal S, McCafferty K, Menzaghi F, Goncalves J. 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. Kidney Med. 2022 Jun 28;4(8):100513. doi: 10.1016/j.xkme.2022.100513. eCollection 2022 Aug.
PMID: 36039153DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Frédérique Menzaghi, PhD
- Organization
- Cara Therapeutics
Study Officials
- STUDY DIRECTOR
Frederique Menzaghi
Cara Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2017
First Posted
September 13, 2017
Study Start
August 14, 2017
Primary Completion
February 11, 2020
Study Completion
February 11, 2020
Last Updated
October 14, 2021
Results First Posted
October 14, 2021
Record last verified: 2021-09