Chronic Kidney Disease-Associated Pruritus in HemodialysisNCT07650851
Clinical Study on the Efficacy and Safety of Nalfurafine Hydrochloride Orally Disintegrating Tablets in Treating Pruritus in Patients Undergoing Maintenance Hemodialysis
A study testing Nalfurafine Hydrochloride and Basic treatment in people with Chronic Kidney Disease-Associated Pruritus in Hemodialysis, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This is a randomized, open-label, multi-center clinical study aimed at evaluating the efficacy and safety of 12 weeks of nalfurafine hydrochloride administration in the treatment of pruritus in patients undergoing maintenance hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease-Associated Pruritus in Hemodialysis
- What is being tested?
- Nalfurafine Hydrochloride and Basic treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Dec 2028
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range of 18-80 years old (including both ends), male or female not limited.
- Chronic renal failure patients who undergo stable dialysis for 3 months or more, receive regular hemodialysis 3 times a week, and are expected to have no significant changes in treatment or rapid changes in their condition during the clinical trial period.
- Within one year prior to signing the informed consent form, the effectiveness of itch treatment (including topical medications such as moisturizers/moisturizers, systemic medications such as antihistamines or antiepileptic drugs, and non pharmacological treatments) was not satisfactory.
- Those who are able to understand and comply with the research procedures and methods, voluntarily participate in this study, and sign a written informed consent form.
- The number of days during which VAS values are measured at both wake-up and bedtime in the baseline period must be no less than 5 days, and the average value of the larger VAS values in morning and evening measurements must not be less than 50 mm.
- The number of days evaluated for the severity of itching in Xie Chuandao during the baseline period must be no less than 5 days at both wake-up and bedtime.
Who cannot join
- Given poor compliance with dialysis treatment, researchers believe that it may affect the effectiveness and safety of clinical studies.
- Patients who plan to undergo kidney transplantation or other elective surgeries during the study period.
- Patients with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or glutamine transferase (GGT) levels exceeding the upper limit of normal (ULN) by 2 times, or total bilirubin levels exceeding the upper limit of normal (ULN) by 2 times during the screening period.
- Skin itching is not caused by chronic kidney disease, including allergic skin diseases (atopic dermatitis, urticaria, eczema, drug rash, etc.), physical skin diseases (prickly heat, solar rash, etc.), infectious skin diseases (insect bite dermatitis, chickenpox, measles, pyoderma, tinea corporis, etc.), cholestatic liver disease, etc.
- Severe cardiovascular disease patients: those who have been screened for NYHA class III or IV, acute myocardial infarction, unstable angina, large pericardial effusion, severe arrhythmia, or abnormal electrocardiogram within the previous 6 months and are deemed unsuitable for inclusion by the researchers.
- Screening for individuals who have been in the active stage of malignant tumors within the previous 12 months, or have received radiotherapy, chemotherapy, targeted therapy, and immunotherapy during this period.
Show all 19Show fewer
- There are uncontrollable or drug-induced fungal, bacterial, viral, or other infections, including tuberculosis patients undergoing anti tuberculosis treatment, patients known to be infected with human immunodeficiency virus (HIV), etc.
- Hypertensive patients who cannot achieve good control with drug therapy: systolic blood pressure ≥ 180mmHg, or diastolic blood pressure ≥ 110mmHg.
- Patients who are currently using glucocorticoids and immunosuppressants.
- Patients with mental illness or cognitive impairment who are unable to correctly understand VAS scores and describe their own feelings.
- Received or adjusted antihistamines, systemic or local corticosteroids (excluding ear or eye preparations), calcineurin inhibitors, gabapentin, pregabalin, and other restricted combination drugs within 7 days prior to screening, or expected to change their treatment regimen during the study period.
- Started receiving or adjusting drugs that may affect the assessment of itch relief efficacy within 2 weeks prior to screening, including but not limited to antipsychotics, sedatives, selective serotonin reuptake inhibitors (SSRIs), anxiolytics, or tricyclic antidepressants, or expected to change their treatment regimen during the study period.
- Individuals with a history of drug abuse, drug dependence, or alcohol abuse within the past 12 months prior to screening.
- Select patients who have received phototherapy for pruritus within the previous month.
- Individuals who have used opioid receptor agonists or antagonists within the past 2 weeks prior to screening.
- Individuals with a known history of allergy to opioid drugs, or those who are allergic to test drug excipients.
- Individuals who have participated in other clinical studies and used the investigational drug or medical device within the 28 days prior to screening, or whose investigational drug is within 5 half lives prior to screening.
- Pregnant women, breastfeeding women, patients with positive pregnancy tests, or those who do not agree to use contraception during the study period.
- Other patients deemed unsuitable by researchers to participate in this clinical study.
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
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
ping Li, +86 010 66935462, liping.8@163.com
About this study
This is a randomized, open-label, multi-center clinical study aimed at evaluating the efficacy and safety of 12 weeks of nalfurafine hydrochloride administration in the treatment of pruritus in patients undergoing maintenance hemodialysis.
- Being tested
- Nalfurafine Hydrochloride, Basic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalfurafine HydrochlorideDrug
Nalfurafine hydrochloride orally disintegrating tablets will be took at a dose of 2.5μg (1 tablet) once daily for 12 consecutive weeks.
Basic treatmentOther
If any itching treatment medication is being received on the day of the screening period, the itching treatment medication (prescription drugs, over-the-counter drugs, moisturizers, etc. with itching as the indication, see the allowed medication list for details) will continue to be used as the basic treatment during the subsequent itching evaluation period. If no itching treatment medication is received by the start of the screening period, no other itching treatment medication will be used as the baseline treatment during the itch evaluation period of the study.
| Study group | Role | What they receive |
|---|---|---|
| Nalfurafine | Experimental | The experimental group took nalfurafine hydrochloride orally disintegrating tablets at a dose of 2.5μg (1 tablet) once daily for 12 consecutive weeks. Receives: Drug: Nalfurafine Hydrochloride |
| Basic treatment | Other | Not described Receives: Other: Basic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analogue Scale (VAS) from baseline
Visual Analog Scale (VAS) is a scale that allows patients to indicate their level of itching on a 10cm scale. The larger the value, the higher the level of itching
Measured: Change from baseline at 12 weeks
Secondary outcomes (9)
Change in average VAS value from baseline across each evaluation period
Visual Analog Scale (VAS) is a scale that allows patients to indicate their level of itching on a 10cm scale. The larger the value, the higher the level of itching
Measured: Changes from baseline at weeks 1, 2, 4, 8, 12 of drug administration and during the follow-up period (1 week after the end of drug administration)
Change in itch score based on the Xie-Kawashima Itch Severity Assessment compared to baseline
Xie-Kawashima Itch Severity Assessment evaluates the severity of itching, scratching behavior, and impact on sleep in patients during both daytime and nighttime. The total score is 0-10 points, with 0-4 points indicating "almost no itching" to "unbearable itching", 4-7 points indicating moderate itching, and 7-10 points indicating severe itching.
Measured: Change from baseline at 12 weeks
The change in itch score from baseline for the Xie-Kawashima Itch Severity Assessment during each evaluation period
Xie-Kawashima Itch Severity Assessment evaluates the severity of itching, scratching behavior, and impact on sleep in patients during both daytime and nighttime. The total score is 0-10 points, with 0-4 points indicating "almost no itching" to "unbearable itching", 4-7 points indicating moderate itching, and 7-10 points indicating severe itching.
Measured: Changes from baseline at weeks 1, 2, 4, 8, 12 of drug administration and during the follow-up period (1 week after the end of drug administration)
Improvement degree of VAS
Visual Analog Scale (VAS) is a scale that allows patients to indicate their level of itching on a 10cm scale. The larger the value, the higher the level of itching
Measured: Change from baseline at 12 weeks
Skin Disease Quality of Life Scale (Skindrex-16)
The Skindex-16 test evaluates the impact of skin diseases on a patient's quality of life by measuring symptoms, emotions, and functional limitations on a scale from 0 to 100. Scores are calculated by averaging responses across all items, where higher values indicate greater impairment. Reference ranges typically categorize scores as mild (<30), moderate (30-60), or severe (>60) effect on quality of life.
Measured: Change from baseline at 12 weeks
Improved sleep quality
Applying the Pittsburgh Sleep Quality Index to Evaluate Sleep Quality The Pittsburgh Sleep Quality Index (PSQI) consists of 9 items, and A and sleep quality are calculated according to the scoring method; B、 Sleep time; C、 Sleep duration; D、 Sleep efficiency; E、 Sleep disorders; F、 Hypnosis drugs; G、 Daytime functional impairment score, and then obtain PSQI total score=A+B+C+D+E+F+G 0-5 points. Good sleep quality 6-10 points. Sleep quality is okay 11-15 points, average sleep quality 16-21 points. Poor sleep quality Calculate baseline and post medication score changes.
Measured: Change from baseline at 12 weeks
Serum endorphin levels
Blood samples were collected from patients before hemodialysis on day 0, day 29, day 57, and day 85. Measure the concentration of endorphins in the serum based on the collected blood samples from the subjects.
Measured: Change from baseline at day 29, day 57, and day 85.
Serum dynorphin levels
Blood samples were collected from patients before hemodialysis on day 0, day 29, day 57, and day 85. Measure the concentration of dynorphins in the serum based on the collected blood samples from the subjects.
Measured: Change from baseline at day 29, day 57, and day 85.
Kidney Disease Quality of Life Scale (KDQOL-36)
The Kidney Disease Quality of Life Scale (KDQOL-36) evaluates the quality of life of patients with kidney disease, consisting of 36 questions covering multiple aspects such as physiology, psychology, and society.The scores for each dimension of the KDQOL-36 scale are usually expressed as 0-100 points, with higher scores indicating better quality of life.
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease-Associated Pruritus in HemodialysisStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Dalian Medical University, Beijing Friendship Hospital, The General Hospital of Northern Theater Command, Tianjin First Central Hospital, RenJi Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Xiangyang Central Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Jiangsu Taizhou People's Hospital, Qilu Hospital of Shandong University, First Affiliated Hospital Xi'an Jiaotong University, Zigong No.1 Peoples Hospital, Chengdu First People's Hospital, The People's Hospital of Leshan, The Third Affiliated Hospital of Wenzhou Medical University, Henan Provincial People's Hospital, Shanghai Changzheng Hospital, Daping Hospital of Army Medical University, First Affiliated Hospital of Wannan Medical College
- Responsible party
- Principal investigator, Chen Xiangmei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650851
- Sponsor's protocol ID
- S2025-460
- Other IDs
- S2025-460-02
- Status last verified
- Mar 2026
- First submitted
- 4 Jun 2026
- Last updated
- 16 Jun 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of Nalfurafine Hydrochloride Orally Disintegrating Tablets in Treating Pruritus in Patients Undergoing Maintenance Hemodialysis
- ClinicalTrials.gov ID
- NCT07650851
- Acronym / sponsor ID
- S2025-460
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Dalian Medical University, Beijing Friendship Hospital, The General Hospital of Northern Theater Command, Tianjin First Central Hospital, RenJi Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Xiangyang Central Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Jiangsu Taizhou People's Hospital, Qilu Hospital of Shandong University, First Affiliated Hospital Xi'an Jiaotong University, Zigong No.1 Peoples Hospital, Chengdu First People's Hospital, The People's Hospital of Leshan, The Third Affiliated Hospital of Wenzhou Medical University, Henan Provincial People's Hospital, Shanghai Changzheng Hospital, Daping Hospital of Army Medical University, First Affiliated Hospital of Wannan Medical College
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Jun 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.
This is a randomized, open-label, multi-center clinical study aimed at evaluating the efficacy and safety of 12 weeks of nalfurafine hydrochloride administration in the treatment of pruritus in patients undergoing maintenance hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nalfurafine | Experimental | Drug: Nalfurafine HydrochlorideThe experimental group took nalfurafine hydrochloride orally disintegrating tablets at a dose of 2.5μg (1 tablet) once daily for 12 consecutive weeks. |
| Basic treatment | Other | Other: Basic treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range of 18-80 years old (including both ends), male or female not limited.
- Chronic renal failure patients who undergo stable dialysis for 3 months or more, receive regular hemodialysis 3 times a week, and are expected to have no significant changes in treatment or rapid changes in their condition during the clinical trial period.
- Within one year prior to signing the informed consent form, the effectiveness of itch treatment (including topical medications such as moisturizers/moisturizers, systemic medications such as antihistamines or antiepileptic drugs, and non pharmacological treatments) was not satisfactory.
- Those who are able to understand and comply with the research procedures and methods, voluntarily participate in this study, and sign a written informed consent form.
- The number of days during which VAS values are measured at both wake-up and bedtime in the baseline period must be no less than 5 days, and the average value of the larger VAS values in morning and evening measurements must not be less than 50 mm.
Key exclusion criteria (19 listed)
- Given poor compliance with dialysis treatment, researchers believe that it may affect the effectiveness and safety of clinical studies.
- Patients who plan to undergo kidney transplantation or other elective surgeries during the study period.
- Patients with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or glutamine transferase (GGT) levels exceeding the upper limit of normal (ULN) by 2 times, or total bilirubin levels exceeding the upper limit of normal (ULN) by 2 times during the screening period.
- Skin itching is not caused by chronic kidney disease, including allergic skin diseases (atopic dermatitis, urticaria, eczema, drug rash, etc.), physical skin diseases (prickly heat, solar rash, etc.), infectious skin diseases (insect bite dermatitis, chickenpox, measles, pyoderma, tinea corporis, etc.), cholestatic liver disease, etc.
- Severe cardiovascular disease patients: those who have been screened for NYHA class III or IV, acute myocardial infarction, unstable angina, large pericardial effusion, severe arrhythmia, or abnormal electrocardiogram within the previous 6 months and are deemed unsuitable for inclusion by the researchers.
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 |
|---|---|---|
| Nalfurafine HydrochlorideNalfurafine hydrochloride orally disintegrating tablets will be took at a dose of 2.5μg (1 tablet) once daily for 12 consecutive weeks. | Drug | Nalfurafine |
| Basic treatmentIf any itching treatment medication is being received on the day of the screening period, the itching treatment medication (prescription drugs, over-the-counter drugs, moisturizers, etc. with itching as the indication, see the allowed medication list for details) will continue to be used as the basic treatment during the subsequent itching evaluation period. If no itching treatment medication is received by the start of the screening period, no other itching treatment medication will be used as the baseline treatment during the itch evaluation period of the study. | Other | Basic treatment |
Primary outcome
Change in Visual Analogue Scale (VAS) from baseline
Time frame: Change from baseline at 12 weeks
Visual Analog Scale (VAS) is a scale that allows patients to indicate their level of itching on a 10cm scale. The larger the value, the higher the level of itching
9 secondary outcomes
Change in average VAS value from baseline across each evaluation period
Time frame: Changes from baseline at weeks 1, 2, 4, 8, 12 of drug administration and during the follow-up period (1 week after the end of drug administration)
Change in itch score based on the Xie-Kawashima Itch Severity Assessment compared to baseline
Time frame: Change from baseline at 12 weeks
The change in itch score from baseline for the Xie-Kawashima Itch Severity Assessment during each evaluation period
Time frame: Changes from baseline at weeks 1, 2, 4, 8, 12 of drug administration and during the follow-up period (1 week after the end of drug administration)
Improvement degree of VAS
Time frame: Change from baseline at 12 weeks
Skin Disease Quality of Life Scale (Skindrex-16)
Time frame: Change from baseline at 12 weeks
Improved sleep quality
Time frame: Change from baseline at 12 weeks
Serum endorphin levels
Time frame: Change from baseline at day 29, day 57, and day 85.
Serum dynorphin levels
Time frame: Change from baseline at day 29, day 57, and day 85.
Kidney Disease Quality of Life Scale (KDQOL-36)
Time frame: Change from baseline at 12 weeks
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 16 Jun 2026.
Related trials for Chronic Kidney Disease-Associated Pruritus in Hemodialysis
RecruitingPhase 2
Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
Pruritus, Chronic Kidney Diseases
Not yet recruitingPhase 4
Efficacy of Nalfurafine for Chronic Kidney Disease-Associated Pruritus in Twice-Weekly Hemodialysis Patients: A Randomized Controlled Trial
Chronic Kidney Disease Associated Pruritus, End Stage Renal Disease on Dialysis
Not yet recruiting
Difelikefalin for Itching in Hemodialysis Patients With Chronic Kidney Disease
Itching Symptoms, CKD 5D, Hemodialysis
Recruiting
Effect of Hand Massage on Chronic Kidney Disease Associated Pruritus in Patients Receiving Hemodialysis
Chronic Kidney Disease Associated Pruritus
Recruiting
Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis
CKD (Chronic Kidney Disease) Stage 5D, Hemodialysis
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 study testing Nalfurafine Hydrochloride and Basic treatment in people with Chronic Kidney Disease-Associated Pruritus in Hemodialysis, run by Chinese PLA General 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 6 inclusion and 19 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: opening soon, as of the sponsor's last update on 16 Jun 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.
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 xiangmei Chen (01066935462, liping.8@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analogue Scale (VAS) from baseline (time frame: Change from baseline at 12 weeks). 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 16 Jun 2026.