Phase 3
N=260
Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
Uremic Pruritus
Bottom Line
View on ClinicalTrials.gov: NCT05885737 ↗Enrolled (actual)
260
Serious AEs
12.8%
Results posted
Sep 2025
Primary outcome: Primary: Change From Baseline in the Weekly Mean of the Daily 24-hour WI-NRS Score at Week 4 of the DB Period — -2.09; -1.27 score on a scale — p=0.0003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Difelikefalin Injection (Drug); Placebo Injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Weekly Mean of the Daily 24-hour WI-NRS Score at Week 4 of the DB Period |
-2.09; -1.27 | 0.0003 sig |
| SECONDARY Percentage of Participants Achieving Greater Than or Equal to (>=) 3-point Improvement From Baseline With Respect to the Weekly Mean of the Daily 24-hour WI-NRS in the DB Period |
21.9; 8.9; 35.8; 22.3; 48.7; 33.8 | — |
| SECONDARY Percentage of Participants Achieving at Least 4-point Improvement From Baseline With Respect to the Weekly Mean of the Daily 24-hour WI-NRS in the DB Period |
10.9; 2.2; 21.2; 11.6; 29.9; 19.7 | — |
| SECONDARY Change From Baseline in the Weekly Mean of the 24-hour WI-NRS Score at Each Week of the DB Period |
-0.68; -0.53; -1.37; -0.89; -1.86; -1.08 | — |
| SECONDARY Change From Baseline in Itch-related Quality-of-life (QoL) as Assessed by the 5-D Itch Scale Total Score (DB Period) |
-3.3; -2.5; -3.9; -2.8; -4.3; -3.6 | — |
| SECONDARY Change From Baseline in Itch-related QoL as Assessed by the 5-D Itch Scale Total Score (OLE Period) |
-5.0; -5.3; -5.4; -5.8; -5.7; -6.0 | — |
| SECONDARY Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (DB Period) |
-9.1; -5.1; -11.3; -7.4; -10.5; -9.5 | — |
| SECONDARY Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (OLE Period) |
-14.7; -14.1; -15.8; -15.2; -17.5; -16.4 | — |
| SECONDARY Patient Global Impression of Change |
20; 14; 46; 29; 22; 49 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
106; 92; 82; 90 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormal 12-lead Electrocardiogram (ECG) |
41; 48; 34; 46 | — |
| SECONDARY Number of Participants With Clinically Relevant Change From Baseline in Vital Signs and Laboratory Evaluations |
0; 0 | — |
Summary
This a multicentre study that consists of a 12-week double-blind period, and an optional 14-week open-label extension period and a 1-week follow-up period.
Eligibility Criteria
Inclusion Criteria
- Subjects with chronic kidney disease (CKD) on HD 3 times weekly for ≥12 weeks prior to the informed consent procedure (including the date of informed consent) who can continue HD without changing its frequency or method.
- If female, is not pregnant, or nursing.
- If female:
- Is surgically sterile; or
- Has been amenorrhoeic for at least 1 year and is over the age of 55 years; or
- Has a negative serum pregnancy test within 7 days before first dose of investigational product and agrees to use acceptable contraceptive measures (e.g., hormonal contraceptives, barrier with spermicide, intrauterine device, vasectomised partner, or abstinence) from the time of informed consent until 7 days after the last dose of investigational product.
- If male, agrees not to donate sperm after the first dose of investigational product administration until 7 days after the last dose of investigational product, and agrees to use a condom with spermicide or abstain from heterosexual intercourse during the study until 7 days after the last dose of investigational product.
- Subjects with a prescription dry body weight between 40 and 100 kg, inclusive.
Exclusion Criteria
- Planned or anticipated to receive a kidney transplant during the study.
- Has localised itch restricted to the palms of the hands.
- Has pruritus only during the dialysis session
- Subjects with severe hepatic impairment (Child-Pugh Class C) or concurrent hepatic cirrhosis.
- Subject is receiving ongoing ultraviolet B treatment and anticipates receiving such treatment during the study.
- Significant systolic or diastolic heart failure (e.g., New York Heart Association Class IV congestive heart failure)
- Subjects with concurrent malignancy except excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ that has been excised or resected completely.
- Known or suspected history of alcohol, narcotic, or other drug abuse, or substance dependence within 12 months prior to screening.
- Severe mental illness or cognitive impairment (e.g., dementia) or other concurrent mental disorder that, in the opinion of the Investigator, would compromise the validity of study measurements.
- Any other relevant acute or chronic medical or neuropsychiatric condition within 3 months prior to screening (e.g., diagnosis of encephalopathy, coma, delirium).
- New or change of treatment received for itch including antihistamines and corticosteroids (oral, IV, or topical) within 14 days prior to screening.
- New or change of prescription for opioids, gabapentin, or pregabalin within 14 days prior to screening.
- Subject is receiving prohibited medication (e.g., nalfurafine hydrochloride, opioid antagonists)
Data sourced from ClinicalTrials.gov (NCT05885737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.