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 developed for pain-related conditions, including acute pain, postoperative pain, post abdominal surgery pain, osteoarthritis of the hip or knee, and pain associated with hemodialysis and chronic kidney disease. It has been studied in Phase 2 clinical trials for these indications.
CR845 is a kappa opioid receptor agonist. It works by activating kappa opioid receptors, which are involved in pain modulation. This mechanism is being studied for its analgesic effects in various pain conditions, including postoperative and osteoarthritis pain.
CR845 is being developed by Cara Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol TVRD. Cara Therapeutics has conducted multiple clinical trials to evaluate CR845 for pain management.
CR845 is in Phase 2 clinical development. It has completed five Phase 2 trials, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities for any indication.
CR845 has been studied in several completed Phase 2 trials, including NCT01361568 for postoperative pain after hysterectomy, NCT01789476 for acute pain after bunionectomy, NCT02542384 for post abdominal surgery pain, and NCT02944448 for osteoarthritis of the hip or knee. These trials were conducted in the United States.
CR845 is the primary name used for this investigational drug in clinical trials and development. No alternative names have been reported for this compound in the available information.