A Phase 3 interventional study of Difelikefalin Injection and Placebo Injection in Uremic Pruritus, sponsored by Vifor Fresenius Medical Care Renal Pharma. Completed at 35 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Vifor Fresenius Medical Care Renal Pharma (part of CSL Limited) · Phase 3, Interventional, and Treatment
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.
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.
490 studies on the registry are indexed under Pruritus; 93 are open to participants now.
This study's enrollment of 260 is above the median of 60 across 422 interventional studies indexed under Pruritus.
Browse Pruritus studies →Vifor Fresenius Medical Care Renal Pharma is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
First submitted after Vifor Fresenius Medical Care Renal Pharma became part of CSL Limited.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
If female:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Difelikefalin Injection
Drug: Placebo Injection
Drug: 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.
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.
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.
Time frame: From Baseline to Week 4
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.
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
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.
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
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.
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)
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.
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)
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.
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)
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.
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)
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.
Time frame: 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.
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)
This study was conducted at 35 investigative sites in China.
| Milestone | Difelikefalin/Difelikefalin | Placebo/Difelikefalin |
|---|---|---|
| Started | 130 | 130 |
| Treated | 129 | 130 |
| Completed | 110 | 117 |
| Not completed | 20 | 13 |
| Withdrew: Adverse event | 4 | 4 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Physician decision | 2 | 0 |
| Withdrew: Withdrawal by subject | 12 | 6 |
| Withdrew: Other: unspecified | 2 | 2 |
| Milestone | Difelikefalin/Difelikefalin | Placebo/Difelikefalin |
|---|---|---|
| Started | 103 | 114 |
| Treated | 103 | 113 |
| Completed | 92 | 106 |
| Not completed | 11 | 8 |
| Withdrew: Adverse event | 3 | 2 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 5 | 5 |
| Withdrew: Other: unspecified | 2 | 1 |
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.
| score on a scale | DB Period: Difelikefalin | DB Period: Placebo |
|---|---|---|
| Change From Baseline in the Weekly Mean of the Daily 24-hour WI-NRS Score at Week 4 of the DB Period | -2.09 ± 0.198 | -1.27 ± 0.194 |
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.
| percentage of participants | DB Period: Difelikefalin | DB Period: Placebo |
|---|---|---|
| Week 4 | 21.9 (11.4 to 38.1) | 8.9 (3.9 to 19.0) |
| Week 8 | 35.8 (22.7 to 51.3) | 22.3 (12.9 to 35.8) |
| Week 12 | 48.7 (34.2 to 63.3) | 33.8 (22.0 to 48.0) |
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.
| percentage of participants | DB Period: Difelikefalin | DB Period: Placebo |
|---|---|---|
| Week 4 | 10.9 (3.7 to 28.1) | 2.2 (0.5 to 8.8) |
| Week 8 | 21.2 (11.2 to 36.6) | 11.6 (5.4 to 23.2) |
| Week 12 | 29.9 (18.1 to 45.3) | 19.7 (10.9 to 32.9) |
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.
| score on a scale | DB Period: Difelikefalin | DB Period: Placebo |
|---|---|---|
| Week 1 | -0.68 ± 0.153 | -0.53 ± 0.149 |
| Week 2 | -1.37 ± 0.179 | -0.89 ± 0.175 |
| Week 3 | -1.86 ± 0.188 | -1.08 ± 0.185 |
| Week 4 | -2.09 ± 0.198 | -1.27 ± 0.194 |
| Week 5 | -2.35 ± 0.208 | -1.46 ± 0.204 |
| Week 6 | -2.51 ± 0.216 | -1.55 ± 0.212 |
| Week 7 | -2.61 ± 0.219 | -1.78 ± 0.215 |
| Week 8 | -2.71 ± 0.222 | -1.96 ± 0.217 |
| Week 9 | -2.90 ± 0.223 | -2.00 ± 0.218 |
| Week 10 | -2.97 ± 0.227 | -2.04 ± 0.222 |
| Week 11 | -3.08 ± 0.228 | -2.16 ± 0.223 |
| Week 12 | -3.11 ± 0.235 | -2.16 ± 0.229 |
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.
| score on a scale | DB Period: Difelikefalin | DB Period: Placebo |
|---|---|---|
| Week 4 | -3.3 ± 0.37 | -2.5 ± 0.36 |
| Week 8 | -3.9 ± 0.38 | -2.8 ± 0.37 |
| Week 12 | -4.3 ± 0.40 | -3.6 ± 0.39 |
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.
| score on a scale | OLE Period: Difelikefalin/Difelikefalin | OLE Period: Placebo/Difelikefalin |
|---|---|---|
| Week 4 | -5.0 ± 0.40 | -5.3 ± 0.38 |
| Week 8 | -5.4 ± 0.40 | -5.8 ± 0.37 |
| Week 12 | -5.7 ± 0.41 | -6.0 ± 0.39 |
| Week 14 | -6.2 ± 0.41 | -6.0 ± 0.38 |
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.
| score on a scale | DB Period: Difelikefalin | DB Period: Placebo |
|---|---|---|
| Week 4 | -9.1 ± 1.46 | -5.1 ± 1.43 |
| Week 8 | -11.3 ± 1.51 | -7.4 ± 1.48 |
| Week 12 | -10.5 ± 1.59 | -9.5 ± 1.55 |
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.
| score on a scale | OLE Period: Difelikefalin/Difelikefalin | OLE Period: Placebo/Difelikefalin |
|---|---|---|
| Week 4 | -14.7 ± 1.47 | -14.1 ± 1.39 |
| Week 8 | -15.8 ± 1.49 | -15.2 ± 1.41 |
| Week 12 | -17.5 ± 1.48 | -16.4 ± 1.39 |
| Week 14 | -18.3 ± 1.56 | -15.8 ± 1.48 |
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.
| Participants | DB Period: Difelikefalin | DB Period: Placebo |
|---|---|---|
| Very much improved | 20 | 14 |
| Much improved | 46 | 29 |
| Minimally improved | 22 | 49 |
| No change | 18 | 24 |
| Minimally worse | 2 | 2 |
| Much worse | 2 | 1 |
| Very Much worse | 0 | 0 |
| Participants | DB Period: Difelikefalin | DB Period: Placebo | OLE Period: Difelikefalin/Difelikefalin | OLE Period: Placebo/Difelikefalin |
|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | 106 | 92 | 82 | 90 |
| Participants | Difelikefalin/Difelikefalin | Placebo/Difelikefalin |
|---|---|---|
| DB period: Week 12 | 41 | 48 |
| OLE period: Week 14 | 34 | 46 |
| Participants | Difelikefalin/Difelikefalin | Placebo/Difelikefalin |
|---|---|---|
| Number of Participants With Clinically Relevant Change From Baseline in Vital Signs and Laboratory Evaluations | 0 | 0 |
Collected over From Baseline up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow-up). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DB Period: Difelikefalin | 0/129 (0%) | 18/129 (14%) | 85/129 (65.9%) |
| DB Period: Placebo | 0/130 (0%) | 12/130 (9.2%) | 66/130 (50.8%) |
| OLE Period: Difelikefalin/Difelikefalin | 0/103 (0%) | 19/103 (18.4%) | 65/103 (63.1%) |
| OLE Period: Placebo/Difelikefalin | 0/113 (0%) | 12/113 (10.6%) | 69/113 (61.1%) |
| Event | DB Period: Difelikefalin | DB Period: Placebo | OLE Period: Difelikefalin/Difelikefalin | OLE Period: Placebo/Difelikefalin |
|---|---|---|---|---|
| Acute myocardial infarctionCardiac disorders | 0/129 | 0/130 | 2/103 | 0/113 |
| Cardiac failure chronicCardiac disorders | 0/129 | 0/130 | 2/103 | 0/113 |
| Cerebral infarctionNervous system disorders | 1/129 | 0/130 | 2/103 | 0/113 |
| PneumoniaInfections and infestations | 0/129 | 2/130 | 1/103 | 2/113 |
| Arteriovenous fistula site complicationInjury, poisoning and procedural complications | 2/129 | 2/130 | 0/103 | 0/113 |
| Arteriovenous fistula occlusionInjury, poisoning and procedural complications | 2/129 | 0/130 | 0/103 | 1/113 |
| Arteriovenous fistula thrombosisInjury, poisoning and procedural complications | 2/129 | 0/130 | 1/103 | 1/113 |
| Cardiac failureCardiac disorders | 0/129 | 2/130 | 0/103 | 0/113 |
| Cardiac failure acuteCardiac disorders | 0/129 | 1/130 | 1/103 | 1/113 |
| Angina pectorisCardiac disorders | 0/129 | 0/130 | 1/103 | 0/113 |
| Event | DB Period: Difelikefalin | DB Period: Placebo | OLE Period: Difelikefalin/Difelikefalin | OLE Period: Placebo/Difelikefalin |
|---|---|---|---|---|
| HyperkalaemiaMetabolism and nutrition disorders | 21/129 | 21/130 | 20/103 | 21/113 |
| HypotensionVascular disorders | 21/129 | 8/130 | 11/103 | 15/113 |
| Dialysis hypotensionVascular disorders | 19/129 | 9/130 | 13/103 | 16/113 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 18/129 | 11/130 | 11/103 | 15/113 |
| DizzinessNervous system disorders | 16/129 | 8/130 | 6/103 | 6/113 |
| Upper respiratory tract infectionInfections and infestations | 13/129 | 14/130 | 9/103 | 11/113 |
| TachycardiaCardiac disorders | 6/129 | 6/130 | 3/103 | 9/113 |
| ConstipationGastrointestinal disorders | 9/129 | 4/130 | 4/103 | 1/113 |
| HypocalcaemiaMetabolism and nutrition disorders | 3/129 | 2/130 | 7/103 | 2/113 |
| DiarrhoeaGastrointestinal disorders | 6/129 | 6/130 | 7/103 | 3/113 |
Analysis was performed on the full analysis set (FAS). The FAS included all participants who were randomised to treatment, received at least 1 dose of investigational product and had a non-missing baseline assessment for the weekly mean of the daily 24-hour Worst Itch Numeric Rating Scale (WI-NRS) score.
| Age, Continuous(years) | DB Period: Difelikefalin | DB Period: Placebo | Total |
|---|---|---|---|
| Mean | 56.3 ± 12.26 | 55.7 ± 12.38 | 56.0 ± 12.30 |
| Sex: Female, Male(Participants) | DB Period: Difelikefalin | DB Period: Placebo | Total |
|---|---|---|---|
| Female | 44 | 42 | 86 |
| Male | 85 | 88 | 173 |
| Race/Ethnicity, Customized(Participants) | DB Period: Difelikefalin | DB Period: Placebo | Total |
|---|---|---|---|
| Asian - Chinese | 129 | 130 | 259 |
| WI-NRS(score on a scale) | DB Period: Difelikefalin | DB Period: Placebo | Total |
|---|---|---|---|
| Mean | 7.35 ± 1.291 | 7.00 ± 1.223 | 7.18 ± 1.268 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
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.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Difelikefalin
Vifor Fresenius Medical Care Renal Pharma →