Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CR845 /kg · 7 trials · 3 indications
Assessed by monitoring of adverse events.
Intensity of itch will be measured using an 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". LS means estimated percent, odds ratio and P value used a logistic regression model.
Assessed by physical examination, monitoring of adverse events, vital signs and laboratory assessments
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.
Using the Numeric Rating Scale (NRS) to quantify the difference between CR845-treated patients and placebo-treated patients.
| Arm | Type | Description |
|---|---|---|
| CR845 0.5mcg/kg | EXPERIMENTAL | IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week) |
| Placebo | PLACEBO_COMPARATOR | IV Placebo administered after each dialysis session (3 times/week) |
| CR845 1 mcg/kg | EXPERIMENTAL | Part A of study: IV CR845 1 mcg/kg administered after each dialysis session (3 times/week) |
| CR845 1.5mcg/kg | EXPERIMENTAL | Part A of study: IV CR845 1.5 mcg/kg administered after each dialysis session (3 times/week) |
| CR845 IV 1 mcg/kg | ACTIVE_COMPARATOR | CR845 IV solution will be supplied in 2 mL glass vials.Study drug will be administered as an IV bolus into an infusion line, the volume is dependent upon the patient's body weight. |
| CR845 IV 0.5 mcg/kg | ACTIVE_COMPARATOR | CR845 solution will be supplied in 2 mL glass vials. Study drug will be administered as an IV bolus into an infusion line, the volume is dependent upon the patient's body weight. |
| Placebo IV | PLACEBO_COMPARATOR | Placebo will be supplied in matched vials containing the same volume of buffer but with no active drug. It will be administered as an IV bolus into an infusion line, the volume is dependent upon the patient's body weight. |
| CR845 0.5 mcg/kg IV (Therapeutic Dose) | EXPERIMENTAL | - |
| CR845 3 mcg/kg IV (Supratherapeutic Dose) | EXPERIMENTAL | - |
| Moxifloxacin 400 mg | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CR845 0.5 mcg/kg | DRUG | IV CR845 0.5 mcg/kg administered three times/week |
| Placebo | DRUG | IV placebo administered three times/week |
| CR845 | DRUG | IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week) |
| CR845 1 mcg/kg | DRUG | IV medication delivered three times/week |
| CR845 1.5mcg/kg | DRUG | IV medication delivered three times/week |
| CR845 IV 1 mcg/kg | DRUG | CR845 IV 1 mcg/kg will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours. Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed. Saline infusion (IV 0.45%) for fluid replenishment will be provided. |
| CR845 IV 0.5 mcg/kg | DRUG | CR845 IV 0.5 mcg/kg will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours. Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed. Saline infusion (IV 0.45%) for fluid replenishment will be provided. |
| Placebo IV | DRUG | Placebo IV will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours. Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed. Saline infusion (IV 0.45%) for fluid replenishment will be provided. |
| CR845 0.5 mcg/kg IV | DRUG | 0.5 mcg/kg IV CR845 |
| CR845 3 mcg/kg IV | DRUG | 3 mcg/kg IV CR845 |
| Moxifloxacin 400 mg Oral Tablet | DRUG | 400 mg Oral Moxifloxacin |
Key Inclusion Criteria: To be eligible for inclusion into the study, a patient must meet the following criteria: * Has end-stage renal disease (ESRD) and has been on hemodialysis 3 times per week for at least 3 months prior to the start of screening; * Has at least 2 single-pool Kt/V measurements ...
CR845 is an investigational small molecule being studied for pain and uremic pruritus. It has been evaluated in clinical trials for osteoarthritis of the hip or knee, acute pain, and conditions related to chronic kidney disease, including uremic pruritus in patients on hemodialysis. It is not approved and remains in clinical development.
CR845 is being developed by Cara Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker CARA. The company has sponsored multiple clinical trials of CR845, including Phase 1 and Phase 2 studies in the United States.
CR845 has completed Phase 2 clinical trials for osteoarthritis and related pain conditions. It has also completed Phase 1 studies in healthy subjects and patients with end stage renal disease on hemodialysis. The drug is investigational and has not been approved by regulatory authorities.
CR845 has been studied in several completed trials, including NCT02524197 and NCT02944448 for osteoarthritis of the hip or knee, NCT03947970 for pharmacokinetics in hemodialysis patients and healthy subjects, and NCT04019574 for effects on the QTc interval in healthy subjects. All trials are completed.
Yes, CR845 is also known as difelikefalin. Clinical trial records refer to the drug as both CR845 and difelikefalin, including studies evaluating its pharmacokinetics and metabolism in patients with end stage renal disease on hemodialysis and in healthy subjects.