A Phase 3 interventional study of CR845 0.5 mcg/kg in Uremic Pruritus, sponsored by Cara Therapeutics, Inc.. Completed at 47 sites in 4 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-10-15.
Sponsored by Cara Therapeutics, Inc. · Phase 3, Interventional, and Treatment
This is a multicenter, open-label study to evaluate the safety and effectiveness of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes an up to 12-week Treatment Period.
Screening Period: The Screening Period includes a Screening Visit and a Run-In Period. Informed consent will be obtained prior to performing any study-specific procedures. The Screening Visit will occur within 21 days prior to the start of the Run-in Period. Patients will start the Run-in Period during the week prior to Treatment Period to complete eligibility verification.
Treatment Period: All scheduled study visits during the Treatment Period will be conducted on dialysis days. Patients will be administered CR845 as an IV bolus after the end of their dialysis during a Treatment Period of up to 12 weeks so that each patient will receive CR845 3 times weekly for a total of up to 36 doses. End of treatment (EOT) is defined as the first day of dialysis following the last dose of drug. The EOT procedures will be conducted on the dialysis visit following the last dose of study drug.
Follow-up Visit: A final safety Follow up Visit will be conducted 7-10 days after the EOT/Early Termination Visit.
354 studies on the registry are indexed under Pruritus; 74 are open to participants now.
This study's enrollment of 222 is above the median of 60 across 294 interventional studies indexed under Pruritus.
Browse Pruritus studies →Cara Therapeutics, Inc. is the lead sponsor of 24 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 5 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
To be eligible for inclusion into the study, a patient must meet the following criteria:
Prior to Treatment:
Key Exclusion Criteria:
A patient will be excluded from the study if any of the following criteria are met:
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
Drug: CR845 0.5 mcg/kg
IV CR845 0.5 mcg/kg administered three times/week
Also known as: CR845, Difelikefalin
Number of Participants With AEs.
Assessed by monitoring of adverse events.
Time frame: Up to Follow-Up Visit (Week 13-14)
| Milestone | CR845 0.5mcg/kg |
|---|---|
| Started | 222 |
| Completed | 197 |
| Not completed | 25 |
Assessed by monitoring of adverse events.
| Participants | CR845 0.5mcg/kg |
|---|---|
| Number of Participants With AEs. | 143 |
Collected over Up to Follow-Up Visit (Week 13-14). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CR845 0.5mcg/kg | 3/222 (1.4%) | 45/222 (20.3%) | 11/222 (5%) |
| Event | CR845 0.5mcg/kg |
|---|---|
| HyperkalaemiaMetabolism and nutrition disorders | 5/222 |
| Clostridium difficile colitisInfections and infestations | 3/222 |
| SepsisInfections and infestations | 3/222 |
| Arteriovenous fistula thrombosisInjury, poisoning and procedural complications | 3/222 |
| SyncopeNervous system disorders | 3/222 |
| AnaemiaBlood and lymphatic system disorders | 2/222 |
| Cardio-respiratory arrestCardiac disorders | 2/222 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 2/222 |
| InfluenzaInfections and infestations | 2/222 |
| OsteomyelitisInfections and infestations | 2/222 |
| Event | CR845 0.5mcg/kg |
|---|---|
| DiarrhoeaGastrointestinal disorders | 11/222 |
| Age, Continuous(years) | CR845 0.5mcg/kg |
|---|---|
| Mean | 58.1 ± 12.81 |
| Sex: Female, Male(Participants) | CR845 0.5mcg/kg |
|---|---|
| Female | 101 |
| Male | 121 |
| Race (NIH/OMB)(Participants) | CR845 0.5mcg/kg |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 7 |
| Native Hawaiian or Other Pacific Islander | 3 |
| Black or African American | 110 |
| White | 96 |
| More than one race | 4 |
| Unknown or Not Reported | 0 |
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Plan to share: No
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Cara Therapeutics, Inc.