Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus

NCT05885737 | Completed Phase 3 Results

• 2 other identifiers: KOR-CHINA-301CTR20220844
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 35

Brief 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.

Conditions

Uremic Pruritus

Keywords

Uremic Pruritus; Chronic kidney disease-associated pruritus; CKD-aP; Difelikefalin

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Weekly Mean of the Daily 24-hour WI-NRS Score at Week 4 of the DB Period

  On a daily basis, participants recorded the intensity of the worst itching they experienced over the past 24 hours using a numerical rating scale (NRS) scale from 0 to 10, where 0 represents "no itching" and 10 was "worst itching imaginable". A higher score indicated a more severe outcome. The weekly mean of the daily values of the daily 24-hour WI-NRS was calculated for the analysis. The least square (LS) means of change from baseline to Week 4 in the weekly mean of the daily 24-hour WI-NRS score was estimated using the mixed model repeated measures (MMRM) method. The MMRM model included use of prior anti-itch medication (yes/no), presence of specific medical conditions at baseline (yes/no), treatment, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline WI-NRS score as fixed continuous effects.

  From Baseline to Week 4

Secondary Outcomes (11)

• 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

  From Baseline, and at Weeks 4, 8, and 12

• 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

  From Baseline, and at Weeks 4, 8, and 12

• Change From Baseline in the Weekly Mean of the 24-hour WI-NRS Score at Each Week of the DB Period

  From Baseline to Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12

• Change From Baseline in Itch-related Quality-of-life (QoL) as Assessed by the 5-D Itch Scale Total Score (DB Period)

  From Baseline to Weeks 4, 8, and 12

• Change From Baseline in Itch-related QoL as Assessed by the 5-D Itch Scale Total Score (OLE Period)

  From Baseline to OLE Period - Weeks 4, 8, 12, and 14

Study Arms (3)

12-weeks double-blind period - Difelikefalin

EXPERIMENTAL

Drug: Difelikefalin Injection

12-weeks double-blind period - Placebo

PLACEBO COMPARATOR

Drug: Placebo Injection

14-weeks optional open-label period following the double-blind period - Difelikefalin

EXPERIMENTAL

Drug: Difelikefalin Injection

Interventions

Difelikefalin Injection DRUG

Participants receive Difelikefalin three times a week (0.5 micrograms/kg dry body weight). Difelikefalin is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis.

12-weeks double-blind period - Difelikefalin; 14-weeks optional open-label period following the double-blind period - Difelikefalin

Placebo Injection DRUG

Participants receive Placebo three times a week (0.5 micrograms/kg dry body weight). Placebo is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis.

12-weeks double-blind period - Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vifor Fresenius Medical Care Renal Pharma: lead
• Tigermed Consulting Co., Ltd: collaborator

Study Sites (35)

Investigator Site 25

Baotou, China

Location

Investigator Site 01

Beijing, China

Location

Investigator Site 07

Beijing, China

Location

Investigator Site 26

Changsha, China

Location

Investigator Site 06

Guangzhou, China

Location

Investigator Site 12

Jiaxing, China

Location

Investigator Site 02

Lanzhou, China

Location

Investigator Site 34

Mianyang, China

Location

Investigator Site 03

Nanjing, China

Location

Investigator Site 10

Nanjing, China

Location

Investigator Site 19

Nanjing, China

Location

Investigator Site 36

Nantong, China

Location

Investigator Site 40

Shanghai, China

Location

Investigator Site 18

Shenyang, China

Location

Investigator Site 21

Shenyang, China

Location

Investigator Site 16

Shenzhen, China

Location

Investigator Site 08

Shihezi, China

Location

Investigator Site 32

Shijiazhuang, China

Location

Investigator Site 41

Shijiazhuang, China

Location

Investigator Site 20

Taiyuan, China

Location

Investigator Site 24

Taiyuan, China

Location

Investigator Site 39

Tianjin, China

Location

Investigator Site 04

Ürümqi, China

Location

Investigator Site 17

Wuhan, China

Location

Investigator Site 33

Wuxi, China

Location

Investigator Site 13

Xiamen, China

Location

Investigator Site 15

Xianyang, China

Location

Investigator Site 22

Xining, China

Location

Investigator Site 38

Xinxiang, China

Location

Investigator Site 11

Yangzhou, China

Location

Investigator Site 30

Yibin, China

Location

Investigator Site 29

Yinchuan, China

Location

Investigator Site 23

Zhengzhou, China

Location

Investigator Site 31

Zhenjiang, China

Location

Investigator Site 35

Zhuzhou, China

Location

MeSH Terms

Interventions

difelikefalin

Results Point of Contact

• Title: Clinical Study Disclosure Manager
• Organization: CSL Behring

clinicaltrials@cslbehring.com

Use email contact

Study Officials

• Milica Enoiu, PhD

  Vifor Pharma Group

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 2, 2023
• Study Start: May 18, 2023
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: September 12, 2025
• Results First Posted: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
• Access Criteria: Proposed research should seek to answer a previously unanswered important medical or scientific question. Applicable country-specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

Locations

CN (35)