Comparison · NCT05885737-0e5771a5
Difelikefalin/Difelikefalin vs Placebo/Difelikefalin: Number of Participants With Clinically Relevant Change From Baseline in Vital Signs and Laboratory Evaluations
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Difelikefalin/Difelikefalin vs Placebo/Difelikefalin: Number of Participants With Clinically Relevant Change From Baseline in Vital Signs and Laboratory Evaluations. Trial comparisons, record NCT05885737-0e5771a5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05885737-0e5771a5
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.0289 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0287 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0287 | 0.0289 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Difelikefalin/Difelikefalin | Participants received Difelikefalin injected into the venous line of the dialysis circuit at the end of each dialysis session for up to 12 weeks (3 times weekly, 36 times in total) in the DB period. Upon completion of the DB period, participants who chose to enter the optional OLE period received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive. | 0 | 129 | OG000 |
| Group 2 | Placebo/Difelikefalin | Participants received Placebo injected into the venous line of the dialysis circuit at the end of each dialysis session matching to Difelikefalin for up to 12 weeks (3 times weekly, 36 times in total) in the DB period. Upon completion of the DB period, participants who chose to enter the optional OLE period received Difelikefalin additionally for up to 14 weeks (3 times weekly), starting at Week 13, and until Week 26 inclusive. | 0 | 130 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Clinically Relevant Change From Baseline in Vital Signs and Laboratory Evaluations
- Description
- Time frame
- From baseline to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow up)
- Population
The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received.
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
- NCT number
- NCT05885737
- Phases
- PHASE3
- Conditions
- Uremic Pruritus
- Interventions
- Difelikefalin Injection, Placebo Injection
- Lead sponsor
- Vifor Fresenius Medical Care Renal Pharma
- Results first posted
- 2025-09-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05885737?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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