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

Primary Purpose

Uremic Pruritus

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Difelikefalin Injection
Placebo Injection
Sponsored by
Vifor Fresenius Medical Care Renal Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uremic Pruritus focused on measuring Uremic Pruritus, Chronic kidney disease-associated pruritus, CKD-aP, Difelikefalin

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Investigator Site 25Recruiting
  • Investigator Site 01Recruiting
  • Investigator Site 07Recruiting
  • Investigator Site 37
  • Investigator Site 26
  • Investigator Site 06Recruiting
  • Investigator Site 12Recruiting
  • Investigator Site 02
  • Investigator Site 09
  • Investigator Site 34Recruiting
  • Investigator Site 03Recruiting
  • Investigator Site 10Recruiting
  • Investigator Site 19Recruiting
  • Investigator Site 36Recruiting
  • Investigator Site 18Recruiting
  • Investigator Site 21
  • Investigator Site 16Recruiting
  • Investigator Site 08Recruiting
  • Investigator Site 32Recruiting
  • Investigator Site 20Recruiting
  • Investigator Site 24
  • Investigator Site 39Recruiting
  • Investigator Site 17
  • Investigator Site 33Recruiting
  • Investigator Site 13Recruiting
  • Investigator Site 15
  • Investigator Site 22
  • Investigator Site 38Recruiting
  • Investigator Site 11Recruiting
  • Investigator Site 30Recruiting
  • Investigator Site 29
  • Investigator Site 23Recruiting
  • Investigator Site 31Recruiting
  • Investigator Site 35Recruiting
  • Investigator Site 04Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

12-weeks double-blind period - Difelikefalin

12-weeks double-blind period - Placebo

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

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in the weekly mean of the daily 24-hour WI-NRS score at Week 4 of the double-blind period
The degree of the most intense itching within a day will be assessed using Worst Itch Numeric Rating Scale (WI-NRS) scores.

Secondary Outcome Measures

Proportion of subjects achieving ≥3-point improvement from baseline with respect to the weekly mean of the daily 24-hour WI-NRS
Proportion of subjects achieving ≥3-point improvement from baseline with respect to the weekly mean of the daily 24-hour WI-NRS
Proportion of subjects achieving ≥3-point improvement from baseline with respect to the weekly mean of the daily 24-hour WI-NRS
Proportion of subjects achieving ≥4-point improvement from baseline with respect to the weekly mean of the daily 24-hour WI-NRS
Proportion of subjects achieving ≥4-point improvement from baseline with respect to the weekly mean of the daily 24-hour WI-NRS
Proportion of subjects achieving ≥4-point improvement from baseline with respect to the weekly mean of the daily 24-hour WI-NRS
Change from baseline in itch-related Quality of Life (QoL) at the end of Week 12 of the double-blind period, as assessed by the 5-D itch scale total score.
The 5-D itch scale is a questionnaire where patients assess the 5 dimensions of itch (degree, duration, direction, disability, and distribution).
Change from baseline in itch-related QoL at the end of Week 12 of the double-blind period, as assessed by the Skindex-10 scale total score.
The Skindex-10 scale is a questionnaire that measures QoL in relationship to the itch intensity.
Patient Global Impression of Change.
The Patient Global Impression of Change is a questionnaire that assesses the change in itch compared to the itch at the start of the study

Full Information

First Posted
May 17, 2023
Last Updated
September 21, 2023
Sponsor
Vifor Fresenius Medical Care Renal Pharma
Collaborators
Tigermed Consulting Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05885737
Brief Title
Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
Official Title
A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase 3, Clinical Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vifor Fresenius Medical Care Renal Pharma
Collaborators
Tigermed Consulting Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremic Pruritus
Keywords
Uremic Pruritus, Chronic kidney disease-associated pruritus, CKD-aP, Difelikefalin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
258 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
12-weeks double-blind period - Difelikefalin
Arm Type
Experimental
Arm Title
12-weeks double-blind period - Placebo
Arm Type
Placebo Comparator
Arm Title
14-weeks optional open-label period following the double-blind period - Difelikefalin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Difelikefalin Injection
Intervention Description
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
Intervention Name(s)
Placebo Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in the weekly mean of the daily 24-hour WI-NRS score at Week 4 of the double-blind period
Description
The degree of the most intense itching within a day will be assessed using Worst Itch Numeric Rating Scale (WI-NRS) scores.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Proportion of subjects achieving ≥3-point improvement from baseline with respect to the weekly mean of the daily 24-hour WI-NRS
Time Frame
Week 4 of double-blind period
Title
Proportion of subjects achieving ≥3-point improvement from baseline with respect to the weekly mean of the daily 24-hour WI-NRS
Time Frame
Week 8 of double-blind period
Title
Proportion of subjects achieving ≥3-point improvement from baseline with respect to the weekly mean of the daily 24-hour WI-NRS
Time Frame
Week 12 of double-blind period
Title
Proportion of subjects achieving ≥4-point improvement from baseline with respect to the weekly mean of the daily 24-hour WI-NRS
Time Frame
Week 4 of double-blind period
Title
Proportion of subjects achieving ≥4-point improvement from baseline with respect to the weekly mean of the daily 24-hour WI-NRS
Time Frame
Week 8 of double-blind period
Title
Proportion of subjects achieving ≥4-point improvement from baseline with respect to the weekly mean of the daily 24-hour WI-NRS
Time Frame
Week 12 of double-blind period
Title
Change from baseline in itch-related Quality of Life (QoL) at the end of Week 12 of the double-blind period, as assessed by the 5-D itch scale total score.
Description
The 5-D itch scale is a questionnaire where patients assess the 5 dimensions of itch (degree, duration, direction, disability, and distribution).
Time Frame
End of double-blind period, week 12
Title
Change from baseline in itch-related QoL at the end of Week 12 of the double-blind period, as assessed by the Skindex-10 scale total score.
Description
The Skindex-10 scale is a questionnaire that measures QoL in relationship to the itch intensity.
Time Frame
End of double-blind period, week 12
Title
Patient Global Impression of Change.
Description
The Patient Global Impression of Change is a questionnaire that assesses the change in itch compared to the itch at the start of the study
Time Frame
End of double-blind period, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KOR-CHINA-301 Clinical Study Team
Phone
+41 58 851 80 00
Email
kor-china-301.study@viforpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milica Enoiu, PhD
Organizational Affiliation
Vifor Pharma Group
Official's Role
Study Director
Facility Information:
Facility Name
Investigator Site 25
City
Baotou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caili Wang
Facility Name
Investigator Site 01
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 07
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 37
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site 26
City
Changsha
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site 06
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 12
City
Jiaxing
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 02
City
Lanzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site 09
City
Lanzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site 34
City
Mianyang
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 03
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 10
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 19
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 36
City
Nantong
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 18
City
Shenyang
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 21
City
Shenyang
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site 16
City
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 08
City
Shihezi
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 32
City
Shijiazhuang
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 20
City
Taiyuan
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 24
City
Taiyuan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site 39
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 17
City
Wuhan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site 33
City
Wuxi
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 13
City
Xiamen
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 15
City
Xianyang
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site 22
City
Xining
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site 38
City
Xinxiang
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 11
City
Yangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changhua Liu
Facility Name
Investigator Site 30
City
Yibin
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 29
City
Yinchuan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site 23
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 31
City
Zhenjiang
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 35
City
Zhuzhou
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 04
City
Ürümqi
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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