New drug could scratch the itch for dialysis patients
NCT ID NCT07526324
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests whether the drug difelikefalin can reduce severe itching in people with chronic kidney disease who are on hemodialysis. About 106 adults will receive either the drug or a placebo after each dialysis session for 6 weeks. The main goal is to see if itching scores improve, with a focus on safety and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Difelikefalin injection
- What this could lead to
- If it works, this could provide a new option to relieve severe itching in people on dialysis, improving their quality of life.
- What could go wrong
- This is a small, early-stage trial with only 106 participants. The drug may not prove more effective than placebo, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 106 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult patients aged ≥18 years * Diagnosed with chronic kidney disease (CKD) on maintenance hemodialysis Undergoing hemodialysis for at least 3 months * Presence of moderate-to-severe pruritus defined as Worst Itching Intensity Numerical Rating Scale (WI-NRS) score ≥4 * Able and willing to provide written informed consent Exclusion Criteria: * Known case of Primary skin disesease associated with Itching. * Known case of liver disease. * Known case of iron defeciency anaemia ,hematological malignancy. * Known case of hypothyroidism \& hyperthyroidism. * Known case of allergic reaction to Opiates . * Pregnancy. * Drug abuse, or substance dependence
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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