New drug may scratch the itch for dialysis patients

NCT ID NCT05885737

Symptom relief Sponsor: Vifor Fresenius Medical Care Renal Pharma Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a drug called difelikefalin to see if it can reduce moderate-to-severe itching in Chinese adults on hemodialysis. 260 participants received either the drug or a placebo three times a week for 12 weeks. The main goal was to measure changes in itching intensity using a daily rating scale.

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 treatment to ease severe itching in people on dialysis, improving their quality of life.
What could go wrong: This is a completed phase 3 trial, but results are not yet published. The drug may not work better 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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

260 people

The number who actually took part.

Started

May 2023

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects with chronic kidney disease (CKD) on HD 3 times weekly for ≥12 weeks prior to the informed consent procedure (including the date of informed consent) who can continue HD without changing its frequency or method. * If female, is not pregnant, or nursing. * If female: 1. Is surgically sterile; or 2. Has been amenorrhoeic for at least 1 year and is over the age of 55 years; or 3. 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. * If male, agrees not to donate sperm after the first dose of investigational product administration until 7 days after the last dose of investigational product, and agrees to use a condom with spermicide or abstain from heterosexual intercourse during the study until 7 days after the last dose of investigational product. * Subjects with a prescription dry body weight between 40 and 100 kg, inclusive. Exclusion Criteria: * Planned or anticipated to receive a kidney transplant during the study. * Has localised itch restricted to the palms of the hands. * Has pruritus only during the dialysis session * Subjects with severe hepatic impairment (Child-Pugh Class C) or concurrent hepatic cirrhosis. * Subject is receiving ongoing ultraviolet B treatment and anticipates receiving such treatment during the study. * Significant systolic or diastolic heart failure (e.g., New York Heart Association Class IV congestive heart failure) * Subjects with concurrent malignancy except excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ that has been excised or resected completely. * Known or suspected history of alcohol, narcotic, or other drug abuse, or substance dependence within 12 months prior to screening. * Severe mental illness or cognitive impairment (e.g., dementia) or other concurrent mental disorder that, in the opinion of the Investigator, would compromise the validity of study measurements. * Any other relevant acute or chronic medical or neuropsychiatric condition within 3 months prior to screening (e.g., diagnosis of encephalopathy, coma, delirium). * New or change of treatment received for itch including antihistamines and corticosteroids (oral, IV, or topical) within 14 days prior to screening. * New or change of prescription for opioids, gabapentin, or pregabalin within 14 days prior to screening. * Subject is receiving prohibited medication (e.g., nalfurafine hydrochloride, opioid antagonists)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Uremic pruritus

Contacts and locations

Locations

Investigator Site 01

Beijing, China
Investigator Site 02

Lanzhou, China
Investigator Site 03

Nanjing, China
Investigator Site 04

Ürümqi, China
Investigator Site 06

Guangzhou, China
Investigator Site 07

Beijing, China
Investigator Site 08

Shihezi, China
Investigator Site 10

Nanjing, China
Investigator Site 11

Yangzhou, China
Investigator Site 12

Jiaxing, China
Investigator Site 13

Xiamen, China
Investigator Site 15

Xianyang, China
Investigator Site 16

Shenzhen, China
Investigator Site 17

Wuhan, China
Investigator Site 18

Shenyang, China
Investigator Site 19

Nanjing, China
Investigator Site 20

Taiyuan, China
Investigator Site 21

Shenyang, China
Investigator Site 22

Xining, China
Investigator Site 23

Zhengzhou, China
Investigator Site 24

Taiyuan, China
Investigator Site 25

Baotou, China
Investigator Site 26

Changsha, China
Investigator Site 29

Yinchuan, China
Investigator Site 30

Yibin, China
Investigator Site 31

Zhenjiang, China
Investigator Site 32

Shijiazhuang, China
Investigator Site 33

Wuxi, China
Investigator Site 34

Mianyang, China
Investigator Site 35

Zhuzhou, China
Investigator Site 36

Nantong, China
Investigator Site 38

Xinxiang, China
Investigator Site 39

Tianjin, China
Investigator Site 40

Shanghai, China
Investigator Site 41

Shijiazhuang, China

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