CompletedPhase 3

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

China260 participantsStarted 2023-05-18

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

Change From Baseline in the Weekly Mean of the Daily 24-hour WI-NRS Score at Week 4 of the DB Period

Timeframe: From Baseline to Week 4

Trial details

NCT IDNCT05885737

SponsorVifor Fresenius Medical Care Renal Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-25

Results submitted2025-08-25

View on ClinicalTrials.gov More Uremic Pruritus trials