Chronic Kidney Disease Associated PruritusPhase 4NCT07769073
Efficacy of Nalfurafine for Chronic Kidney Disease-Associated Pruritus in Twice-Weekly Hemodialysis Patients: A Randomized Controlled Trial
A Phase 4 study testing Nalfurafine Hydrochloride and plasebo in people with Chronic Kidney Disease Associated Pruritus and End Stage Renal Disease on Dialysis, run by Universitas Indonesia.
Trial summary
This study evaluates the efficacy and safety of nalfurafine as a treatment for chronic kidney disease-associated pruritus (CKD-aP) in patients undergoing maintenance hemodialysis twice weekly. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Disease Associated Pruritus, End Stage Renal Disease on Dialysis
- What is being tested?
- Nalfurafine Hydrochloride and plasebo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 17 Aug 2026to 13 Oct 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic kidney disease-associated pruritus (CKD-aP) undergoing maintenance hemodialysis twice weekly for more than 6 months and in a hemodynamically stable condition.
- Aged 18 to 65 years old and willing to participate in the study.
- Received standard therapy for at least 2 weeks and met the moderate to severe pruritus criteria based on Visual Analog Scale (VAS) score and 5-D Pruritus Scale.
- Able to understand and comply with the study instructions/protocol.
Who cannot join
- Patients with active malignancy or active infection.
- Patients with primary skin diseases, such as allergic dermatitis, irritant contact dermatitis, neurodermatitis, or psoriasis.
- Patients with chronic liver disease or cholestatic disease.
- Received phototherapy or acupuncture therapy within the last 1 week prior to study enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study evaluates the efficacy and safety of nalfurafine as a treatment for chronic kidney disease-associated pruritus (CKD-aP) in patients undergoing maintenance hemodialysis twice weekly.
Pruritus (severe itching) is a common and distressing symptom in patients with end-stage renal disease receiving hemodialysis, significantly impairing their quality of life. Nalfurafine is a selective kappa-opioid receptor agonist designed to reduce itching.
The main objective of this clinical trial is to evaluate whether nalfurafine effectively reduces itch intensity and improves symptom control compared to control, while monitoring for any adverse effects.
- Being tested
- Nalfurafine Hydrochloride, plasebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalfurafine HydrochlorideDrug
administered orally
plaseboDrug
administered orally
| Study group | Role | What they receive |
|---|---|---|
| Nalfurafine Group | Experimental | Patients in this arm receive Nalfurafine therapy alongside standard hemodialysis care. Receives: Drug: Nalfurafine Hydrochloride |
| Control Group | Placebo comparator | Patients in this arm receive matching placebo (or standard care) alongside standard hemodialysis care. Receives: Drug: plasebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Visual Analog Scale (VAS) score for pruritus
Pruritus intensity measured using a Visual Analog Scale (VAS) ranging from 0 to 10 (or 0 to 100 mm), where 0 represents no itch and 10 (or 100) represents the worst imaginable itch. Lower scores indicate reduction in itch severity.
Measured: Baseline, Week 1, Week 2, Week 3, and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start17 Aug 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion13 Oct 2026 (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 PruritusStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayu Cahya Andhayani, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769073
- Sponsor's protocol ID
- 26-06-0949
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in order to protect participant confidentiality and privacy in accordance with local ethical guidelines and patient consent.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nalfurafine for Chronic Kidney Disease-Associated Pruritus in Twice-Weekly Hemodialysis Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07769073
- Acronym / sponsor ID
- 26-06-0949
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 13 Oct 2026 (estimated)
- First posted
- 17 Aug 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 study evaluates the efficacy and safety of nalfurafine as a treatment for chronic kidney disease-associated pruritus (CKD-aP) in patients undergoing maintenance hemodialysis twice weekly.
Pruritus (severe itching) is a common and distressing symptom in patients with end-stage renal disease receiving hemodialysis, significantly impairing their quality of life. Nalfurafine is a selective kappa-opioid receptor agonist designed to reduce itching.
The main objective of this clinical trial is to evaluate whether nalfurafine effectively reduces itch intensity and improves symptom control compared to control, while monitoring for any adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nalfurafine Group | Experimental | Drug: Nalfurafine HydrochloridePatients in this arm receive Nalfurafine therapy alongside standard hemodialysis care. |
| Control Group | Placebo comparator | Drug: plaseboPatients in this arm receive matching placebo (or standard care) alongside standard hemodialysis care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with chronic kidney disease-associated pruritus (CKD-aP) undergoing maintenance hemodialysis twice weekly for more than 6 months and in a hemodynamically stable condition.
- Aged 18 to 65 years old and willing to participate in the study.
- Received standard therapy for at least 2 weeks and met the moderate to severe pruritus criteria based on Visual Analog Scale (VAS) score and 5-D Pruritus Scale.
- Able to understand and comply with the study instructions/protocol.
Key exclusion criteria (4 listed)
- Patients with active malignancy or active infection.
- Patients with primary skin diseases, such as allergic dermatitis, irritant contact dermatitis, neurodermatitis, or psoriasis.
- Patients with chronic liver disease or cholestatic disease.
- Received phototherapy or acupuncture therapy within the last 1 week prior to study enrollment.
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 Hydrochlorideadministered orally | Drug | Nalfurafine Group |
| plaseboadministered orally | Drug | Control Group |
Primary outcome
Change from baseline in Visual Analog Scale (VAS) score for pruritus
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Pruritus intensity measured using a Visual Analog Scale (VAS) ranging from 0 to 10 (or 0 to 100 mm), where 0 represents no itch and 10 (or 100) represents the worst imaginable itch. Lower scores indicate reduction in itch severity.
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 17 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in order to protect participant confidentiality and privacy in accordance with local ethical guidelines and patient consent.
Related trials for Chronic Kidney Disease Associated Pruritus
RecruitingPhase 2
Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
Pruritus, Chronic Kidney Diseases
Recruiting
Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis
Adverse Event, Peritoneal Dialysis
Not yet recruiting
Clinical Study on the Efficacy and Safety of Nalfurafine Hydrochloride Orally Disintegrating Tablets in Treating Pruritus in Patients Undergoing Maintenance Hemodialysis
Chronic Kidney Disease-Associated Pruritus in Hemodialysis
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
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nalfurafine Hydrochloride and plasebo in people with Chronic Kidney Disease Associated Pruritus and End Stage Renal Disease on Dialysis, run by Universitas Indonesia.
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 4 inclusion and 4 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Ayu Cahya Andhayani, Internist (+6281359152656, dr.ayu.cahya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Visual Analog Scale (VAS) score for pruritus (time frame: Baseline, Week 1, Week 2, Week 3, and Week 4). 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 17 Aug 2026.