18 and older, any sex, with Uremic Pruritus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12Primary· Week 12
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.
Group
Value
95% CI
CR845 0.5mcg/kg
51.0
42.9 – 58.9
Placebo
27.6
20.2 – 36.6
Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in 5-D Itch Scale Score at the End of Week 12Secondary· Baseline, Week 12
The 5-D Itch Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past 2 weeks. The questions cover five dimensions of itch including the degree, duration of itch/day, direction (improvement/worsening), disability (impact on activities such as work), and body distribution of itch. The 5-D Itch Scale has 5 questions; the total 5-D Itch Scale score ranges from 5 to 25, with higher scores indicating worse responses.
Group
Value
95% CI
Double-blind CR845 0.5mcg/kg
-5.0
-5.7 – -4.4
Double-blind Placebo
-3.7
-4.4 – -3.1
Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12Secondary· Baseline, Week 12
The Skindex-10 Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past week. The questions cover 3 domains: disease, mood/emotional distress, and social functioning domain. The Skindex-10 has 10 questions; the total Skindex-10 score ranges from 0 to 60. A lower total score represents better quality of life.
Group
Value
95% CI
Double-blind CR845 0.5mcg/kg
-17.2
-19.6 – -14.7
Double-blind Placebo
-12.0
-14.5 – -9.6
Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥4 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score at Week 12Secondary· Week 12
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.
Group
Value
95% CI
Double-blind CR845 0.5mcg/kg
38.9
29.8 – 48.7
Double-blind Placebo
18.0
12.1 – 26.0
Adverse events — posted to ClinicalTrials.gov
Time frame: The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes a 12-week Double-blind Phase and a 52-week Open-label Extension Phase.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05533008 — CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysi
· Phase 1
· completed
NCT03998163 — CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Seve
· Phase 3
· completed
NCT03636269 — CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Se
· Phase 3
· completed
Other recruiting trials for Uremic Pruritus
Currently open trials in the same condition.
NCT06446310 — Phase 3 Study of QLG2198 in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
· Phase 3
· recruiting
Other Cara Therapeutics, Inc. trials
Trials by the same sponsor.
NCT05978063 — Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgi
· Phase 2, PHASE3
· terminated
NCT05356403 — CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients W
· Phase 3
· terminated
NCT05387707 — Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moder
· Phase 3
· terminated
NCT05342623 — A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-t
· Phase 3
· terminated
NCT04706975 — Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cara Therapeutics, Inc.
Last refreshed: 26 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03422653.