Pruritus ChronicPhase 4AnrikefonNCT07380113
Anrikefon vs Nalfurafine for Sleep Quality in Hemodialysis Patients With CKD-aP
A Phase 4 study testing Anrikefon and Nalfurafine in people with Pruritus Chronic and Kidney Diseases, Chronic, run by Zhujiang Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to compare a new intravenous drug, Anruikefen, with a traditional oral medication, nalfurafine orally disintegrating tablets, in improving sleep quality in patients with chronic kidney disease-associated pruritus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pruritus Chronic, Kidney Diseases, Chronic, Renal Insufficiency, Chronic
- What is being tested?
- Anrikefon and Nalfurafine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2026to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to understand the procedures and methods of this trial, be willing to strictly follow the clinical research protocol to complete this trial, and voluntarily sign the informed consent form.
- Male or female individuals aged 18 or above and 75 or above.
- Patients with end-stage renal disease received regular hemodialysis three times a week before the screening period (whether they met the requirements for regular dialysis was determined based on the opinions of the researchers).
- Meet the diagnostic criteria for chronic kidney disease-associated pruritus (CKD-aP).
- Patients with chronic kidney disease (CKD) presenting with pruritus, with other identifiable causes of pruritus excluded.
- Pruritus occurring on at least 3 days within a 2-week period, with multiple episodes per day, each lasting for several minutes, and having an impact on the patient's daily life.
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- Recurrent pruritus persisting for at least 6 weeks.A diagnosis requires that all three criteria above be met simultaneously.
- The subjects were evaluated using the Worst Itch Numerical Rating Scale (WI-NRS) for the most severe pruritus intensity and met the baseline pruritus intensity of ≥ 4 points.
- The subjects have completed the Pittsburgh Sleep Quality Index (PSQI) assessment during the screening period and met the baseline PSQI score > 7 points.
Who cannot join
- Participants with other serious systemic diseases that may affect their ability to participate in the study, as assessed by the investigator, including but not limited to:
- Severe cardiovascular diseases, such as unstable angina, myocardial infarction, severe arrhythmias, World Health Organization (WHO) heart function classification III-IV during screening, poorly controlled hypertension or hypotension despite active treatment, and recurrent asthma.
- A history of cerebrovascular accident (CVA) within the last 6 months.
- Malignant tumors, excluding those that are curable, such as cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin, or any other cancer that has been cured (with no evidence of disease recurrence for 5 years).
- It is expected to undergo kidney transplantation and/or parathyroidectomy during the study period.
- The subjects are currently undergoing ultraviolet B treatment or are expected to receive such treatment during the study period.
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- Have participated in any clinical trials of other drugs or medical devices within one month prior to screening (treatment with drugs or medical devices that have received clinical trials).
- Patients who have used the following drugs within 7 days before screening:
- those who have used opioids.
- those who must use opioids other than the investigational drug during the study period.
- those who has used gabapentin, pregabalin and calcineurin inhibitors;
- those who use drugs that can affect the efficacy judgment of anti-itching, including but not limited to antipsychotic drugs, sedative-hypnotic drugs, selective serotonin reuptake inhibitors (SSRIs), anti-anxiety drugs, or tricyclic antidepressants.
- After screening and enrollment, new antihistamines (such as antihistamines and corticosteroids, etc. (oral, intravenous or topical)) were prescribed, or the types, dosages or frequencies of these drugs were changed.
- Patients who have used any hypnotic or sedative medications (including benzodiazepine hypnotics, non-benzodiazepine hypnotics, melatonin receptor agonists, etc.) within 1 month prior to the screening period and baseline assessment.
- There is a history of allergy to opioid drugs, or it is known that there is a history of allergy to investigatory drugs or components of remedial drugs or other drugs or excipients with similar chemical structures.
- Severe hematological and liver function abnormalities during screening, meeting any one of the following clinical laboratory test results:
- Hematology: Hemoglobin < 80g/L.
- Liver function:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5× upper limit of normal (ULN).
- Total bilirubin (TBIL) > 2×ULN.
- Subjects who had any active infections during screening and whom the researchers considered unsuitable for inclusion (including but not limited to acute hepatitis, skin infections, etc.).
- As determined by the researchers, any other physical or mental illness or condition that may increase the risk of the trial, affect the subjects' compliance with the protocol, or affect the subjects' completion of the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital, Southern Medical University, No. 253 Gongye Road, Guangzhou, 510282, China
Guangzhou, Guangdong, 510280
Fengxian Li, +86-20-61643299
About this study
Official title: An Exploratory Study Comparing Anrikefon With Nalfurafine in Improving Sleep Quality Among CKD-aP Patients Undergoing Hemodialysis: An Open-Label Randomized Controlled Clinical Trial
The goal of this clinical trial is to compare a new intravenous drug, Anruikefen, with a traditional oral medication, nalfurafine orally disintegrating tablets, in improving sleep quality in patients with chronic kidney disease-associated pruritus. Sleep quality will be primarily assessed using the Pittsburgh Sleep Quality Index (PSQI). The study will also evaluate the safety of Anruikefen.
The main questions it aims to answer are:
Read more
- Does Anruikefen injection improve sleep quality better than oral nalfurafine?
- Does Anruikefen injection improve patients' quality of life more than oral nalfurafine? Researchers will compare Anruikefen with nalfurafine (an active control drug) to evaluate differences in their effects on sleep quality in patients with chronic kidney disease-associated pruritus.
Participants will:
- Receive either Anruikefen injection (0.3 μg/kg, three times per week) or nalfurafine hydrochloride orally disintegrating tablets (2.5 μg once daily).
- Continue treatment for 4 weeks, followed by a 1-week safety follow-up.
- Complete the Pittsburgh Sleep Quality Index and other quality-of-life questionnaires after one month.
Read the detailed description
This study adopts an open-label, randomized controlled design and enrolls patients with CKD-associated pruritus (CKD-aP) with a WI-NRS score ≥4. Participants are randomized to receive either anrikefon intravenous injection (0.3 μg/kg, three times per week) or nalfurafine orally disintegrating tablets administered orally (2.5 μg/day) for 4 weeks. The primary endpoint is the difference in sleep quality improvement assessed by the Pittsburgh Sleep Quality Index (PSQI). Secondary endpoints include Skindex-10, the 5-D Itch Scale, WI-NRS, KDQOL-36, Patient Global Impression of Change (PGIC), mechanical pain threshold, and serum proteomic analyses. Vital signs, laboratory parameters, and adverse events are monitored throughout the study to comprehensively evaluate the efficacy and safety of the two κ-opioid receptor agonist therapies.
- Conditions
- Pruritus Chronic, Kidney Diseases, Chronic, Renal Insufficiency, Chronic, Uremia; Chronic, Pruritus Due to Systemic Disorder (Disorder), Pruritus Due to Hemodialysis
- Being tested
- Anrikefon, Nalfurafine
- Medical subject headings
- Renal Insufficiency, Chronic, Uremia, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnrikefonDrug
Also called HSK21542
intravenous administration
NalfurafineDrug
Also called TRK-820, Nalfurafine hydrochloride
oral administration
| Study group | Role | What they receive |
|---|---|---|
| Anrikefon | Experimental | Participants receive anrikefon injection at a dose of 0.3 μg/kg, administered three times per week after dialysis, for 4 consecutive weeks. Receives: Drug: Anrikefon |
| Nalfurafine | Active comparator | Participants receive nalfurafine hydrochloride orally disintegrating tablets at a dose of 2.5 μg per day, administered orally after dinner, for 4 weeks. Receives: Drug: Nalfurafine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
Questionnaire survey
Measured: Baseline, 4 weeks after medication
Secondary outcomes (8)
5D-itching scale
Questionnaire survey
Measured: Baseline，2/4 weeks after medication
Skindex-10 scale
Questionnaire survey
Measured: Baseline，1 /2 /3/ 4 weeks after medication
WI-NRS score
Questionnaire survey
Measured: Baseline, every dialysis day during the treatment period
Kidney Disease Quality of Life instrument™ - 36 items
Questionnaire survey
Measured: Baseline, 4 weeks after medication
Patient Global Impression of Change
Questionnaire survey
Measured: 4 weeks after medication
Mechanical pain threshold
The electronic pressure sensor pain measurement method involves connecting a probe with a relatively thin tip to a force sensor. Based on the principle of Newton's third law, it records in real time the magnitude of the force applied by the probe to the pain measurement site. The pressure number at which the subject first feels pain is the pain threshold.
Measured: Baseline, 4 weeks after medication
Peripheral blood metabolomics analysis
Peripheral blood samples will be analyzed using liquid chromatography/mass spectrometry.
Measured: Baseline, 4 weeks after medication
Peripheral blood proteomics analysis
The proteins in blood will be digested with trypsin to obtain peptides. The peptides will be analyzed by liquid nanochromatography coupled to mass spectrometry. The identification of the proteins will be carried out using the UniProt Homo Sapiens database using the Proteome Discoverer software (ThermoFisher Scientific).
All proteomic markers in capillary blood will be reported in arbitrary units as a relative unit of measurement.
Measured: Baseline, 4 weeks after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start22 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pruritus ChronicStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengxian Li, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380113
- Sponsor's protocol ID
- 2025-KY-496-02
- Acronym
- Anrikefon
- Status last verified
- Aug 2026
- First submitted
- 14 Jan 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study Comparing Anrikefon With Nalfurafine in Improving Sleep Quality Among CKD-aP Patients Undergoing Hemodialysis: An Open-Label Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07380113
- Acronym / sponsor ID
- Anrikefon / 2025-KY-496-02
- Conditions
- Pruritus Chronic, Kidney Diseases, Chronic, Renal Insufficiency, Chronic, Uremia; Chronic, Pruritus Due to Systemic Disorder (Disorder), Pruritus Due to Hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare a new intravenous drug, Anruikefen, with a traditional oral medication, nalfurafine orally disintegrating tablets, in improving sleep quality in patients with chronic kidney disease-associated pruritus. Sleep quality will be primarily assessed using the Pittsburgh Sleep Quality Index (PSQI). The study will also evaluate the safety of Anruikefen.
The main questions it aims to answer are:
- Does Anruikefen injection improve sleep quality better than oral nalfurafine?
- Does Anruikefen injection improve patients' quality of life more than oral nalfurafine? Researchers will compare Anruikefen with nalfurafine (an active control drug) to evaluate differences in their effects on sleep quality in patients with chronic kidney disease-associated pruritus.
Participants will:
- Receive either Anruikefen injection (0.3 μg/kg, three times per week) or nalfurafine hydrochloride orally disintegrating tablets (2.5 μg once daily).
- Continue treatment for 4 weeks, followed by a 1-week safety follow-up.
- Complete the Pittsburgh Sleep Quality Index and other quality-of-life questionnaires after one month.
Detailed description
This study adopts an open-label, randomized controlled design and enrolls patients with CKD-associated pruritus (CKD-aP) with a WI-NRS score ≥4. Participants are randomized to receive either anrikefon intravenous injection (0.3 μg/kg, three times per week) or nalfurafine orally disintegrating tablets administered orally (2.5 μg/day) for 4 weeks. The primary endpoint is the difference in sleep quality improvement assessed by the Pittsburgh Sleep Quality Index (PSQI). Secondary endpoints include Skindex-10, the 5-D Itch Scale, WI-NRS, KDQOL-36, Patient Global Impression of Change (PGIC), mechanical pain threshold, and serum proteomic analyses. Vital signs, laboratory parameters, and adverse events are monitored throughout the study to comprehensively evaluate the efficacy and safety of the two κ-opioid receptor agonist therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anrikefon | Experimental | Drug: AnrikefonParticipants receive anrikefon injection at a dose of 0.3 μg/kg, administered three times per week after dialysis, for 4 consecutive weeks. |
| Nalfurafine | Active comparator | Drug: NalfurafineParticipants receive nalfurafine hydrochloride orally disintegrating tablets at a dose of 2.5 μg per day, administered orally after dinner, for 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be able to understand the procedures and methods of this trial, be willing to strictly follow the clinical research protocol to complete this trial, and voluntarily sign the informed consent form.
- Male or female individuals aged 18 or above and 75 or above.
- Patients with end-stage renal disease received regular hemodialysis three times a week before the screening period (whether they met the requirements for regular dialysis was determined based on the opinions of the researchers).
- Meet the diagnostic criteria for chronic kidney disease-associated pruritus (CKD-aP).
- The subjects were evaluated using the Worst Itch Numerical Rating Scale (WI-NRS) for the most severe pruritus intensity and met the baseline pruritus intensity of ≥ 4 points.
Key exclusion criteria (22 listed)
- Participants with other serious systemic diseases that may affect their ability to participate in the study, as assessed by the investigator, including but not limited to:
- It is expected to undergo kidney transplantation and/or parathyroidectomy during the study period.
- The subjects are currently undergoing ultraviolet B treatment or are expected to receive such treatment during the study period.
- Have participated in any clinical trials of other drugs or medical devices within one month prior to screening (treatment with drugs or medical devices that have received clinical trials).
- Patients who have used the following drugs within 7 days before screening:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnrikefonAlso: HSK21542intravenous administration | Drug | Anrikefon |
| NalfurafineAlso: TRK-820, Nalfurafine hydrochlorideoral administration | Drug | Nalfurafine |
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: Baseline, 4 weeks after medication
Questionnaire survey
8 secondary outcomes
5D-itching scale
Time frame: Baseline，2/4 weeks after medication
Skindex-10 scale
Time frame: Baseline，1 /2 /3/ 4 weeks after medication
WI-NRS score
Time frame: Baseline, every dialysis day during the treatment period
Kidney Disease Quality of Life instrument™ - 36 items
Time frame: Baseline, 4 weeks after medication
Patient Global Impression of Change
Time frame: 4 weeks after medication
Mechanical pain threshold
Time frame: Baseline, 4 weeks after medication
Peripheral blood metabolomics analysis
Time frame: Baseline, 4 weeks after medication
Peripheral blood proteomics analysis
Time frame: Baseline, 4 weeks after medication
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anrikefon and Nalfurafine in people with Pruritus Chronic and Kidney Diseases, Chronic, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fengxian Li, DM (+86-20-62782857, lifengxian81@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (time frame: Baseline, 4 weeks after medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.