Trial · NCT05885737
Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
NCT05885737, Phase 3, Completed, Vifor Fresenius Medical Care Renal Pharma; results first posted 2025-09-12
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus. Trials, record NCT05885737. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05885737
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
- NCT number
- NCT05885737
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 260 participants, actual
- Lead sponsor
- Vifor Fresenius Medical Care Renal Pharma
- Conditions
- Uremic Pruritus
- Interventions
- Difelikefalin Injection, Placebo Injection
- First posted
- 2023-06-02
- Last updated
- 2025-09-12
- Results first posted
- 2025-09-12
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Weekly Mean of the Daily 24-hour WI-NRS Score at Week 4 of the DB Period | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (DB Period) | From Baseline to Weeks 4, 8, and 12 | 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. |
| Secondary | Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (OLE Period) | From Baseline to OLE Period - Weeks 4, 8, 12, and 14 | 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. |
| Secondary | Patient Global Impression of Change | At Week 12 | 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. |
| Secondary | Number of Participants With Adverse Events (AEs) | Up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow up) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Weekly Mean of the Daily 24-hour WI-NRS Score at Week 4 of the DB Period | From Baseline to Week 4 | Analysis was performed on the FAS. The FAS included all participants who were randomized 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 WI-NRS score. Here, 'overall number of participants analyzed', 'N' = participants with available data for this outcome measure. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Analysis was performed on FAS. The FAS included all participants who were randomized 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 WI-NRS score. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint. | percentage of participants | NUMBER |
| SECONDARY | 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 | Analysis was performed on FAS. The FAS included all participants who were randomized 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 WI-NRS score. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint. | percentage of participants | NUMBER |
| SECONDARY | 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 | Analysis was performed on FAS. The FAS included all participants who were randomized 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 WI-NRS score. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Analysis was performed on FAS. The FAS included all participants who were randomized 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 WI-NRS score. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Analysis was performed on the OLE Safety Analysis Set, which included all participants who received at least 1 dose of IP in the OLE period. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (DB Period) | From Baseline to Weeks 4, 8, and 12 | Analysis was performed on FAS. The FAS included all participants who were randomized 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 WI-NRS score. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (OLE Period) | From Baseline to OLE Period - Weeks 4, 8, 12, and 14 | For the OLE period analysis was performed on OLE-SAS, which included all participants who received at least 1 dose of IP in the OLE period. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Global Impression of Change | At Week 12 | Analysis was performed on FAS. The FAS included all participants who were randomized 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 WI-NRS score. Here, 'overall number of participants analyzed', 'N' = participants with available data for the outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events (AEs) | Up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow up) | Analysis was performed on safety analysis set in DB period (DB-SAF). DB-SAF included all randomized participants who received at least 1 dose of investigational product during the DB period. For the OLE period analysis was performed on OLE Safety Analysis Set, which included all participants who received at least 1 dose of IP in the OLE period. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Weekly Mean of the Daily 24-hour WI-NRS Score at Week 4 of the DB Period | DB Period: Difelikefalin | -2.09 | Standard Error 0.198 | score on a scale | |
| Change From Baseline in the Weekly Mean of the Daily 24-hour WI-NRS Score at Week 4 of the DB Period | DB Period: Placebo | -1.27 | Standard Error 0.194 | score on a scale | |
| 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 | DB Period: Difelikefalin | Week 4 | 21.9 | 95% Confidence Interval 11.4 to 38.1 | percentage of participants |
| 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 | DB Period: Placebo | Week 4 | 8.9 | 95% Confidence Interval 3.9 to 19.0 | percentage of participants |
| 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 | DB Period: Difelikefalin | Week 8 | 35.8 | 95% Confidence Interval 22.7 to 51.3 | percentage of participants |
| 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 | DB Period: Placebo | Week 8 | 22.3 | 95% Confidence Interval 12.9 to 35.8 | percentage of participants |
| 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 | DB Period: Difelikefalin | Week 12 | 48.7 | 95% Confidence Interval 34.2 to 63.3 | percentage of participants |
| 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 | DB Period: Placebo | Week 12 | 33.8 | 95% Confidence Interval 22.0 to 48.0 | percentage of participants |
| 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 | DB Period: Difelikefalin | Week 4 | 10.9 | 95% Confidence Interval 3.7 to 28.1 | percentage of participants |
| 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 | DB Period: Placebo | Week 4 | 2.2 | 95% Confidence Interval 0.5 to 8.8 | percentage of participants |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| DB Period | STARTED | Difelikefalin/Difelikefalin | 130 | |
| DB Period | STARTED | Placebo/Difelikefalin | 130 | |
| DB Period | Treated | Difelikefalin/Difelikefalin | 129 | |
| DB Period | Treated | Placebo/Difelikefalin | 130 | |
| DB Period | COMPLETED | Difelikefalin/Difelikefalin | 110 | |
| DB Period | COMPLETED | Placebo/Difelikefalin | 117 | |
| DB Period | NOT COMPLETED | Difelikefalin/Difelikefalin | 20 | |
| DB Period | NOT COMPLETED | Placebo/Difelikefalin | 13 | |
| OLE Period | STARTED | Difelikefalin/Difelikefalin | 103 | |
| OLE Period | STARTED | Placebo/Difelikefalin | 114 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events264
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hyperkalaemia | Metabolism and nutrition disorders | DB Period: Difelikefalin | 21 | 129 | 27 |
| other | Hyperkalaemia | Metabolism and nutrition disorders | DB Period: Placebo | 21 | 130 | 25 |
| other | Hyperkalaemia | Metabolism and nutrition disorders | OLE Period: Difelikefalin/Difelikefalin | 20 | 103 | 32 |
| other | Hyperkalaemia | Metabolism and nutrition disorders | OLE Period: Placebo/Difelikefalin | 21 | 113 | 34 |
| other | Hypocalcaemia | Metabolism and nutrition disorders | DB Period: Difelikefalin | 3 | 129 | 3 |
| other | Hypocalcaemia | Metabolism and nutrition disorders | DB Period: Placebo | 2 | 130 | 3 |
| other | Hypocalcaemia | Metabolism and nutrition disorders | OLE Period: Difelikefalin/Difelikefalin | 7 | 103 | 7 |
| other | Hypocalcaemia | Metabolism and nutrition disorders | OLE Period: Placebo/Difelikefalin | 2 | 113 | 2 |
| other | Hypercalcaemia | Metabolism and nutrition disorders | DB Period: Difelikefalin | 2 | 129 | 2 |
| other | Hypercalcaemia | Metabolism and nutrition disorders | DB Period: Placebo | 1 | 130 | 1 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DB Period: Difelikefalin | 0 | 129 |
| Total, all-cause mortality | DB Period: Placebo | 0 | 130 |
| Total, all-cause mortality | OLE Period: Difelikefalin/Difelikefalin | 0 | 103 |
| Total, all-cause mortality | OLE Period: Placebo/Difelikefalin | 0 | 113 |
| Total, other adverse events | DB Period: Difelikefalin | 85 | 129 |
| Total, other adverse events | DB Period: Placebo | 66 | 130 |
| Total, other adverse events | OLE Period: Difelikefalin/Difelikefalin | 65 | 103 |
| Total, other adverse events | OLE Period: Placebo/Difelikefalin | 69 | 113 |
| Total, serious adverse events | DB Period: Difelikefalin | 18 | 129 |
| Total, serious adverse events | DB Period: Placebo | 12 | 130 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Difelikefalin/Difelikefalin vs Placebo/Difelikefalin: Number of Participants With Clinically Relevant Change From Baseline in Vital Signs and Laboratory Evaluations |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05885737
GET https://conductscience.org/api/trials/v1/NCT05885737/results?page=2