kappa opioid receptor agonist
Difelikefalin clinical trials
Answer
Difelikefalin has 25 registered trials: 2 running, 15 completed, 5 stopped early. 9 posted results.
Trial registerClinicalTrials.gov and EU CTIS, read 2026-10-03
| Trial | Title | Status | Phase | Registered | Results |
|---|---|---|---|---|---|
| NCT06593392 Trial register | Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus | currently recruiting participants | - | 2024-09-19 | - |
| 2023-509909-74-00 Trial register | An Open-label, Single Arm Study to Evaluate the Safety and Tolerability of Intravenous Difelikefalin in Adolescents Aged 12 to 17 Years on Haemodialysis with Mo | Not stated | 2 | - | - |
| NCT07526324 Trial register | Difelikefalin for Itching in Hemodialysis Patients With Chronic Kidney Disease | not yet recruiting participants | - | 2026-04-13 | - |
| NCT05885737 Trial register | Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus | completed | - | 2023-06-02 | Posted |
| NCT05885763 Trial register | Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis | completed | - | 2023-06-02 | Posted |
| NCT05978063 Trial register | Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica | terminated before completion | - | 2023-08-07 | - |
| NCT05342623 Trial register | A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus | terminated before completion | - | 2022-04-22 | - |
| NCT05356403 Trial register | CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus | terminated before completion | - | 2022-05-02 | - |
| 2023-503957-36-00 Trial register | A 2-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate-to-Severe Pruritus in Adult Subject | Not stated | 2/3 | - | - |
| NCT05387707 Trial register | Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With | terminated before completion | - | 2022-05-24 | - |
| NCT03617536 Trial register | A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus | completed | - | 2018-07-11 | Posted |
| NCT03995212 Trial register | Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus | terminated before completion | - | 2019-06-21 | - |
| NCT04706975 Trial register | Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT) | completed | - | 2021-01-13 | - |
| NCT05533008 Trial register | CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients | completed | - | 2022-09-08 | - |
| NCT05031546 Trial register | Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin | approved for marketing | - | 2021-09-02 | - |
| NCT03422653 Trial register | A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1) | completed | - | 2018-01-25 | Posted |
| NCT03636269 Trial register | CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus | completed | - | 2018-08-03 | Posted |
| NCT04018027 Trial register | Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis | completed | - | 2019-07-12 | - |
| NCT03998163 Trial register | CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus | completed | - | 2019-05-07 | Posted |
| NCT03281538 Trial register | Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus | completed | - | 2017-06-20 | Posted |
| NCT02944448 Trial register | A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee | completed | - | 2016-10-04 | Posted |
| NCT02858726 Trial register | Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus | completed | - | 2016-07-29 | Posted |
| NCT04019574 Trial register | Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects | completed | - | 2019-07-15 | - |
| NCT03947970 Trial register | Study to Evaluate the Pharmacokinetics and Metabolism of [14C] CR845 (Difelikefalin) in Patients With End Stage Renal Disease on Hemodialysis and in Healthy Sub | completed | - | 2019-05-13 | - |
| NCT02542384 Trial register | A Study Evaluating the Overall Pain Relief and Safety of Intravenous (IV) CR845 in Patients Undergoing Abdominal Surgery | completed | - | 2015-09-03 | - |
Source: ClinicalTrials.gov and EU CTIS, read 2026-10-03. Not medical advice.
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