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

NCT ID: NCT05885737

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-18
• Study Completion Date: 2024-09-25

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.

Detailed Description

Total study duration for a single subject is 31 to 32 weeks with a 4-week screening period, a 12-week double-blind period, a 14-week optional open-label extension period, and a 1-week follow-up period. For subjects not participating in the open-label extension period, the total study duration is 17 weeks.

Difelikefalin will be administered in the double-blind and open-label period 3 times a week at the end of each dialysis session. The total dose of the investigational product will be determined based on the subject's prescription dry body weight.

The primary objective of the study is:

To evaluate the efficacy of difelikefalin 0.5 μg/kg compared to placebo in reducing the intensity of itch in HD Chinese subjects with moderate-to-severe pruritus.

Conditions

Uremic Pruritus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

12-weeks double-blind period - Difelikefalin

Group Type: EXPERIMENTAL

Difelikefalin Injection

Intervention Type: 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 - Placebo

Group Type: PLACEBO_COMPARATOR

Placebo Injection

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Difelikefalin Injection

Intervention Type: 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.

Interventions

Difelikefalin Injection

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.

Intervention Type: DRUG

Placebo Injection

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.

Intervention Type: DRUG

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:

1. Is surgically sterile; or

2. Has been amenorrhoeic for at least 1 year and is over the age of 55 years; or

3. 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tigermed Consulting Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Vifor Fresenius Medical Care Renal Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Milica Enoiu, PhD

Role: STUDY_DIRECTOR

Vifor Pharma Group

Locations

Investigator Site 25

Baotou, , China

Investigator Site 01

Beijing, , China

Investigator Site 07

Beijing, , China

Investigator Site 26

Changsha, , China

Investigator Site 06

Guangzhou, , China

Investigator Site 12

Jiaxing, , China

Investigator Site 02

Lanzhou, , China

Investigator Site 34

Mianyang, , China

Investigator Site 03

Nanjing, , China

Investigator Site 10

Nanjing, , China

Investigator Site 19

Nanjing, , China

Investigator Site 36

Nantong, , China

Investigator Site 40

Shanghai, , China

Investigator Site 18

Shenyang, , China

Investigator Site 21

Shenyang, , China

Investigator Site 16

Shenzhen, , China

Investigator Site 08

Shihezi, , China

Investigator Site 32

Shijiazhuang, , China

Investigator Site 41

Shijiazhuang, , China

Investigator Site 20

Taiyuan, , China

Investigator Site 24

Taiyuan, , China

Investigator Site 39

Tianjin, , China

Investigator Site 04

Ürümqi, , China

Investigator Site 17

Wuhan, , China

Investigator Site 33

Wuxi, , China

Investigator Site 13

Xiamen, , China

Investigator Site 15

Xianyang, , China

Investigator Site 22

Xining, , China

Investigator Site 38

Xinxiang, , China

Investigator Site 11

Yangzhou, , China

Investigator Site 30

Yibin, , China

Investigator Site 29

Yinchuan, , China

Investigator Site 23

Zhengzhou, , China

Investigator Site 31

Zhenjiang, , China

Investigator Site 35

Zhuzhou, , China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan: DB Period

View Document

Document Type: Statistical Analysis Plan: OLE Period

View Document

Other Identifiers

CTR20220844

Identifier Type: OTHER

Identifier Source: secondary_id

KOR-CHINA-301

Identifier Type: -

Identifier Source: org_study_id