Uremic PruritusPhase 3NCT05885737
Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
A Phase 3 study testing Difelikefalin Injection in people with Uremic Pruritus, run by Vifor Fresenius Medical Care Renal Pharma at 35 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Uremic Pruritus
- What is being tested?
- Difelikefalin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 35 sitesChina
- Study dates
- 18 May 2023to 25 Sep 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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)
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
China35 sites
Investigator Site 25
Baotou
Investigator Site 01
Beijing
Investigator Site 07
Beijing
Investigator Site 26
Changsha
Investigator Site 06
Guangzhou
Investigator Site 12
Jiaxing
Investigator Site 02
Lanzhou
Investigator Site 34
Mianyang
Investigator Site 03
Nanjing
Investigator Site 10
Nanjing
Investigator Site 19
Nanjing
Investigator Site 36
Nantong
Investigator Site 40
Shanghai
Investigator Site 18
Shenyang
Investigator Site 21
Shenyang
Investigator Site 16
Shenzhen
Investigator Site 08
Shihezi
Investigator Site 32
Shijiazhuang
Investigator Site 41
Shijiazhuang
Investigator Site 20
Taiyuan
Investigator Site 24
Taiyuan
Investigator Site 39
Tianjin
Investigator Site 04
Ürümqi
Investigator Site 17
Wuhan
Investigator Site 33
Wuxi
Investigator Site 13
Xiamen
Investigator Site 15
Xianyang
Investigator Site 22
Xining
Investigator Site 38
Xinxiang
Investigator Site 11
Yangzhou
Investigator Site 30
Yibin
Investigator Site 29
Yinchuan
Investigator Site 23
Zhengzhou
Investigator Site 31
Zhenjiang
Investigator Site 35
Zhuzhou
About this study
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
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.
Read the 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
- Being tested
- Difelikefalin Injection, Placebo Injection
- Keywords
- Uremic Pruritus, Chronic kidney disease-associated pruritus, CKD-aP, Difelikefalin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difelikefalin InjectionDrug
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.
Placebo InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 12-weeks double-blind period - Difelikefalin | Experimental | Not described Receives: Drug: Difelikefalin Injection |
| 12-weeks double-blind period - Placebo | Placebo comparator | Not described Receives: Drug: Placebo Injection |
| 14-weeks optional open-label period following the double-blind period - Difelikefalin | Experimental | Not described Receives: Drug: Difelikefalin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
On a daily basis, participants recorded the intensity of the worst itching they experienced over the past 24 hours using a 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. Missing weekly mean WI-NRS data were imputed using missing at random (MAR) multiple imputation (MI) approach, assuming that participants who do not have weekly mean WI-NRS score at a timepoint would have similar weekly mean WI-NRS scores as other participants in their respective treatment arm who have complete data. The percentage of participants were estimated using a logistic regression model with terms for treatment group, baseline WI-NRS score, use of anti-itch medication during the week prior to randomisation, and the presence of specific medical conditions at baseline.
Measured: 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
On a daily basis, participants recorded the intensity of the worst itching they experienced over the past 24 hours using a 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. Missing weekly mean WI-NRS data were imputed using MAR-MI approach, assuming that participants who do not have weekly mean WI-NRS score at a timepoint would have similar weekly mean WI-NRS scores as other participants in their respective treatment arm who have complete data.
Measured: 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
On a daily basis, participants recorded the intensity of the worst itching they experienced over the past 24 hours using a 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 was calculated for the analysis. The weekly mean of the daily values of the daily 24-hour WI-NRS was calculated for the analysis. 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.
Measured: 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)
The 5-D itch scale is a questionnaire where participants assess the 5 dimensions of itch (degree, duration, direction, disability, and distribution). The scores of each of the 5 domains are achieved separately and then summed together to obtain a total 5-D score. 5-D itch scale scores can potentially range between 5 (no pruritus) and 25 (most severe pruritus) where a higher score indicates a more severe outcome. The LS means of change from baseline in itch-related QoL as assessed by the 5-D itch scale total score was estimated using the MMRM method. The MMRM model included use of prior anti-itch medication (yes/no), presence of specific medical conditions at baseline (yes/no), treatment sequence, visit, and treatment sequence-by-visit-interaction as fixed categorical effects and baseline 5-D Itch score (total score) as fixed continuous effects.
Measured: 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)
The 5-D itch scale is a questionnaire where participants assess the 5 dimensions of itch (degree, duration, direction, disability, and distribution). The scores of each of the 5 domains are achieved separately and then summed together to obtain a total 5-D score. 5-D itch scale scores can potentially range between 5 (no pruritus) and 25 (most severe pruritus) where a higher score indicates a more severe outcome. The LS means of change from baseline in itch-related QoL as assessed by the 5-D itch scale total score was estimated using the MMRM method. The MMRM model included use of prior anti-itch medication (yes/no), presence of specific medical conditions at baseline (yes/no), treatment sequence, visit, and treatment sequence-by-visit-interaction as fixed categorical effects and baseline 5-D Itch score (total score) as fixed continuous effects.
Measured: From Baseline to OLE Period - Weeks 4, 8, 12, and 14
Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (DB Period)
The Skindex-10 scale is a questionnaire that measures QoL in relationship to the itch intensity. Participants are asked the question "During the past week, how often have you been bothered by" and respond by filling in 1 of 7 circles numbered from 0 (labelled with the anchor phrase "never bothered") to 6 (labelled as "always bothered") for each of the 10 questions. The total score is the sum of the numeric value of each answered question. Here, a higher score indicated a severe outcome. The LS means of change from baseline in itch-related QoL as assessed by the Skindex-10 scale total score was estimated using the 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 skindex-10 scale score (total score) as fixed continuous effects.
Measured: From Baseline to Weeks 4, 8, and 12
Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (OLE Period)
The Skindex-10 scale is a questionnaire that measures QoL in relationship to the itch intensity. Participants are asked the question "During the past week, how often have you been bothered by" and respond by filling in 1 of 7 circles numbered from 0 (labelled with the anchor phrase "never bothered") to 6 (labelled as "always bothered") for each of the 10 questions. The total score is the sum of the numeric value of each answered question. Here, a higher score indicated a severe outcome. The LS means of change from baseline in itch-related QoL as assessed by the Skindex-10 scale total score was estimated using the 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 skindex-10 scale score (total score) as fixed continuous effects.
Measured: From Baseline to OLE Period - Weeks 4, 8, 12, and 14
Patient Global Impression of Change
The Patient Global Impression of Change is a global participant reported outcome measure that assesses the change in itch (no change, improvement or worsening) overall relative to the start of the study. The scale has only 1 item, and the participant was asked to mark the category that best describes the change in itch ranging from "Very Much Improved" to "Very Much Worse". Number of participants within all individual categories are reported here.
Measured: At Week 12
Number of Participants With Adverse Events (AEs)
Measured: Up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow up)
Number of Participants With Clinically Significant Abnormal 12-lead Electrocardiogram (ECG)
Measured: Up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow up)
Number of Participants With Clinically Relevant Change From Baseline in Vital Signs and Laboratory Evaluations
Measured: From baseline to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start18 May 2023
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uremic PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Fresenius Medical Care Renal Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Milica Enoiu, PhD, Study director, Vifor Pharma Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885737
- Sponsor's protocol ID
- KOR-CHINA-301
- Other IDs
- CTR20220844
- Status last verified
- Aug 2025
- First submitted
- 17 May 2023
- Last updated
- 12 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05885737
- Acronym / sponsor ID
- KOR-CHINA-301
- Conditions
- Uremic Pruritus
- Keywords
- Uremic Pruritus, Chronic kidney disease-associated pruritus, CKD-aP, Difelikefalin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Vifor Fresenius Medical Care Renal PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- 18 May 2023 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Posted 12 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Difelikefalin InjectionParticipants 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. | Drug | 12-weeks double-blind period - Difelikefalin, 14-weeks optional open-label period following the double-blind period - Difelikefalin |
| Placebo InjectionParticipants 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. | Drug | 12-weeks double-blind period - Placebo |
Primary outcome
Change From Baseline in the Weekly Mean of the Daily 24-hour WI-NRS Score at Week 4 of the DB Period
Time frame: From Baseline to Week 4
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.
11 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: From Baseline to OLE Period - Weeks 4, 8, 12, and 14
Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (DB Period)
Time frame: From Baseline to Weeks 4, 8, and 12
Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (OLE Period)
Time frame: From Baseline to OLE Period - Weeks 4, 8, 12, and 14
Patient Global Impression of Change
Time frame: At Week 12
Number of Participants With Adverse Events (AEs)
Time frame: Up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow up)
Number of Participants With Clinically Significant Abnormal 12-lead Electrocardiogram (ECG)
Time frame: Up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow up)
Number of Participants With Clinically Relevant Change From Baseline in Vital Signs and Laboratory Evaluations
Time frame: From baseline to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milica Enoiu, PhD study director
Vifor Pharma Group
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Difelikefalin Injection in people with Uremic Pruritus, run by Vifor Fresenius Medical Care Renal Pharma at 35 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Weekly Mean of the Daily 24-hour WI-NRS Score at Week 4 of the DB Period (time frame: From Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.