10 completed, 5 terminated, 1 approved for marketing, 1 not yet recruiting. 8 Phase 3, 6 Phase 2, 3 Phase 1, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 8 | Completed 4, Terminated 4 |
| Phase 2 | 6 | Completed 3, Terminated 2, Recruiting 1 |
| Phase 1 | 3 | Completed 3 |
| Not applicable | 1 | Not yet recruiting 1 |
Follow difelikefalin: new trials by email Literature Review of difelikefalin trials Research Report on difelikefalin
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus Difelikefalin - Pruritus, Chronic Kidney Diseases | Phase 2 | Recruiting | Vifor Fresenius Medical Care Renal Pharma | 18 | 2026-08-04 | 2026-10-23 |
| Difelikefalin for Itching in Hemodialysis Patients With Chronic Kidney Disease Difelikefalin Injection, Normal Saline (0.9% NaCl) - Itching Symptoms, CKD 5D, Hemodialysis | Not applicable | Not yet recruiting | Chittagong Medical College | 106 | 2026-04-26 | 2026-04-13 |
| Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica difelikefalin 2.0 mg tablets, difelikefalin 1.0 mg tablets, difelikefalin 0.25 mg tablets - Pruritus, Notalgia Paresthetica | Phase 2 / Phase 3 | Terminated | Cara Therapeutics, Inc. | 214 | 2023-08-01 | 2024-06-21 |
| Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis Difelikefalin Injection - End Stage Renal Disease on Hemodialysis | Phase 1 | Completed | Vifor Fresenius Medical Care Renal Pharma | 30 | 2023-06-26 | 2025-02-14 |
| Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus Difelikefalin Injection, Placebo Injection - Uremic Pruritus | Phase 3 | Completed | Vifor Fresenius Medical Care Renal Pharma | 260 | 2023-05-18 | 2025-09-12 |
| CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus Difelikefalin 1 mg Oral Tablet, Placebo Oral Tablet - Chronic Kidney Diseases, Pruritus | Phase 3 | Terminated | Cara Therapeutics, Inc. | 105 | 2022-08-26 | 2024-05-07 |
| 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 Atopic Dermatitis difelikefalin 0.25 mg, difelikefalin 0.5 mg, TCS Cream - Pruritus, Atopic Dermatitis | Phase 3 | Terminated | Cara Therapeutics, Inc. | 287 | 2022-08-16 | 2024-02-22 |
| A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus Difelikefalin 1 mg Oral Tablet, Placebo Oral Tablet - Chronic Kidney Diseases, Pruritus | Phase 3 | Terminated | Cara Therapeutics, Inc. | 286 | 2022-05-17 | 2024-05-07 |
| Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT) difelikefalin 2.0 mg, Placebo - Pruritus, Notalgia Paresthetica | Phase 2 | Completed | Cara Therapeutics, Inc. | 126 | 2021-01-11 | 2023-05-22 |
| CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients CR845 0.5 mcg/kg, Placebo - Hemodialysis | Phase 1 | Completed | Cara Therapeutics, Inc. | 35 | 2019-12-31 | 2022-09-08 |
| Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis difelikefalin 0.25 mg, difelikefalin 0.5 mg, difelikefalin 1.0 mg - Pruritus, Atopic Dermatitis | Phase 2 | Completed | Cara Therapeutics, Inc. | 401 | 2019-06-29 | 2022-04-04 |
| Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus CR845 1.0 mg, Placebo - Cholestatic Pruritus | Phase 2 | Terminated | Cara Therapeutics, Inc. | 14 | 2019-06-25 | 2023-07-03 |
| Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects CR845 0.5 mcg/kg IV, CR845 3 mcg/kg IV, Moxifloxacin 400 mg Oral Tablet - Healthy | Phase 1 | Completed | Cara Therapeutics, Inc. | 57 | 2019-06-20 | 2020-02-21 |
| CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus CR845 0.5 mcg/kg - Uremic Pruritus | Phase 3 | Completed | Cara Therapeutics, Inc. | 222 | 2019-05-06 | 2021-10-15 |
| CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus CR845 0.5 mcg/kg, Placebo - Uremic Pruritus | Phase 3 | Completed | Cara Therapeutics, Inc. | 473 | 2018-07-17 | 2022-04-26 |
| A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus CR845 0.25 mg Oral Tablet, CR845 0.5 mg Oral Tablet, CR845 1 mg Oral Tablet - Chronic Kidney Diseases, Pruritus | Phase 2 | Completed | Cara Therapeutics, Inc. | 269 | 2018-07-05 | 2024-01-24 |
| A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1) CR845 0.5 mcg/kg, Placebo - Uremic Pruritus | Phase 3 | Completed | Cara Therapeutics, Inc. | 378 | 2018-02-20 | 2022-04-26 |
| Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin Difelikefalin - Uremic Pruritus | Approved for marketing | Cara Therapeutics, Inc. | 2022-05-18 |
Pruritus (13) · Renal Insufficiency, Chronic (9) · Kidney Failure, Chronic (8) · Dermatitis, Atopic (2) · Eczema (2) · Liver Cirrhosis, Biliary (1)
Cara Therapeutics, Inc. (14) · Vifor Fresenius Medical Care Renal Pharma (3) · Chittagong Medical College (1)
United States (13) · Canada (4) · Poland (4) · China (3) · Germany (3) · Hungary (3) · Spain (3) · Australia (2) · Czechia (2) · South Korea (2) · United Kingdom (2) · Argentina (1) · Brazil (1) · Bulgaria (1) · Greece (1)
Milica Enoiu, PhD (2) · Kristine Nograles (1) · Nilam Shah (1)
PMID 36039153, PMID 37968132, PMID 39037824, PMID 33283264, PMID 36016762, PMID 31702883, PMID 36185706, PMID 36780675, PMID 37927032, PMID 38196014, PMID 41686509
2023 (1)