Uremic PruritusPhase 3NCT04728984
A Multi-site Bridging Study of Nalfurafine Hydrochloride Orally Disintegrating Tablet
A Phase 3 study testing Nalfurafine Hydrochloride in people with Uremic Pruritus, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial summary
This is a multisite study to evaluate the efficacy, safety and plasma concentration of Nalfurafine Hydrochloride orally disintegrating tablet in the treatment of refractory pruritus in maintenance hemodialysis patients, and to bridge the efficacy data from Japan Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uremic Pruritus
- What is being tested?
- Nalfurafine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2020to 31 Oct 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic renal failure patients who have been on stable dialysis for 3 months or more, receive regular hemodialysis 3 times a week, and expect no significant treatment changes or dramatic changes in their condition during the clinical trial;
- In the 1 year prior to signing the informed consent, patients who were treated with the following drugs A and/or B: (A) Systematic treatment (oral, injection, etc.) of "prescribed drugs for pruritus" (including antihistamines or antiallergic drugs) for more than 2 weeks consecutively; (B). Use of " prescribed drugs for pruritus" (ointments, etc.) or topical treatment of moisturizers prescribed by physicians;
- Patients who had received treatment in inclusion criteria (2) but did not respond;
- When signing the informed consent, the patient is older than 18 years old (including 18 years old), regardless of gender;
- During the observation period before administration (D8-14), the number of days for which the VAS values were measured at the time of getting up and going to bed should not be less than 5 days, and the average value of the larger VAS values in the morning and evening measurements should not be less than 50 mm;
- During the observation period before administration (D8-14), The number of days in which the larger VAS value measured in the morning and evening measurements (if there was a missing time in getting up or going to bed, the value which has been measured was selected) is not less than 20 mm, was not less than 5 days;
- During the observation period before administration (D8-14), the number of days in which the pruritus severity of Hsie-Kawashima's was evaluated at the time of getting up and at the time of going to bed was not less than 5 days, in which the maximum of the pruritus score was not less than 3 (moderate) in the morning and evening measurements was more than half.
Who cannot join
- Malignant tumor patients;
- Patients with mental illness or mental retardation who cannot correctly understand the VAS score and describe their feelings;
- Patients with alanine aminotransferase (ALT), aspartate aminotransferase (AST) or glutamine transferase (GGT) or total bilirubin higher than twice the upper limit of normal value (ULN) at the screening stage;
- Patients currently suffering from atopic dermatitis or chronic urticaria;
- Patients allergic to opioids;
- Patients with drug or alcohol dependence;
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- Patients who had received light therapy for pruritus within 1 month prior to signing the informed consent;
- Patients who have participated in a previous clinical study of Nalfurafine Hydrochloride and have taken Nalfurafine Hydrochloride, or who have participated in this clinical study and have been officially enrolled;
- Participated in other clinical studies (including research drugs and medical devices) within 1 month before signing the informed consent;
- Pregnant women, lactating women, women who have a positive pregnancy test or who do not agree to use contraception during the study period;
- Patients who, as determined by the investigator, could not have their VAS score recorded by themselves for any reason;
- Patients whose comorbidities or previous medical history, as determined by the investigator, would affect the evaluation of this clinical study;
- After testing, human immunodeficiency virus antibody positive;
- Other patients judged by the investigator to be unsuitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, 310003
Chen Jianghua, Master
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multisite Bridging Clinical Study of Nalfurafine Hydrochloride Orally Disintegrating Tablet in the Treatment of Refractory Pruritus in Hemodialysis Patients
This is a multisite study to evaluate the efficacy, safety and plasma concentration of Nalfurafine Hydrochloride orally disintegrating tablet in the treatment of refractory pruritus in maintenance hemodialysis patients, and to bridge the efficacy data from Japan
Read the detailed description
This clinical trial is a bridging study. when selecting the subjects, the most appropriate pruritus medication for the subjects was used first.Then, subjects with "existing treatment-resistant" pruritus will continue to receive basic pruritus treatment if the corresponding treatment is not sufficiently effective, and the experimental drug or placebo will be added to this treatment to evaluate the effectiveness.
- Conditions
- Uremic Pruritus
- Being tested
- Nalfurafine Hydrochloride, Nalfurafine Hydrochloride+Placebo, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalfurafine HydrochlorideDrug
Nalfurafine Hydrochloride 2.5μg*2
; Oral administration after dinner, once daily for 14 consecutive days
Nalfurafine Hydrochloride+PlaceboDrug
Nalfurafine Hydrochloride 2.5μg+ A placebo pill; Oral administration after dinner, once daily for 14 consecutive days
PlaceboDrug
two placebo pills; Oral administration after dinner, once daily for 14 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Nalfurafine Hydrochloride 5μg | Experimental | Oral administration after dinner, once daily for 14 consecutive days Receives: Drug: Nalfurafine Hydrochloride |
| Nalfurafine Hydrochloride 2.5μg | Experimental | Oral administration after dinner, once daily for 14 consecutive days Receives: Drug: Nalfurafine Hydrochloride+Placebo |
| Placebo | Placebo comparator | Oral administration after dinner, once daily for 14 consecutive days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in VAS of Nalfurafine Hydrochloride versus Placebo
The Variation = the mean of the daily maximum VAS value during the observation period before administration(D8-14) - the mean of the daily maximum VAS value during the administration period (D25-31). Only the days on which the VAS values were recorded during the day and night were evaluated.
Measured: up to 38(+1) days
Secondary outcomes (3)
Variation in pruritus scores based on the Hsie-Kawashima pruritus severity assessment method
Pruritus scores were assessed during the observation period before administration(D8-14) and administration period (D25-31), and only the days when pruritus scores were recorded during the day and night were evaluated.
Measured: up to 38(+1) days
Variation in nocturnal pruritus scores based on the Hsie-Kawashima pruritus severity assessment method (improvement of pruritus-induced sleep disorders).
After calculating the mean values of nocturnal pruritus scores during the observation period before administration(D8-14) and administration period (D25-31), the variation was calculated.
Measured: up to 38(+1) days
Improvement degree of VAS
The average VAS value of the observation period before administration (D8-14) and the average VAS value of the administration period (D25-31) were calculated, and the improvement degree was determined as very effective, effective and ineffective according to the variation of the average VAS value.
Measured: up to 38(+1) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start7 Sep 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uremic PruritusStudies of the same condition, open and under way.
- More trials run by Shenyang Sunshine Pharmaceutical Co., LTD.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728984
- Sponsor's protocol ID
- SYSS-Remitch-HD-III-01
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2021
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multisite Bridging Clinical Study of Nalfurafine Hydrochloride Orally Disintegrating Tablet in the Treatment of Refractory Pruritus in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04728984
- Acronym / sponsor ID
- SYSS-Remitch-HD-III-01
- Conditions
- Uremic Pruritus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 28 Jan 2021 (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 multisite study to evaluate the efficacy, safety and plasma concentration of Nalfurafine Hydrochloride orally disintegrating tablet in the treatment of refractory pruritus in maintenance hemodialysis patients, and to bridge the efficacy data from Japan
Detailed description
This clinical trial is a bridging study. when selecting the subjects, the most appropriate pruritus medication for the subjects was used first.Then, subjects with "existing treatment-resistant" pruritus will continue to receive basic pruritus treatment if the corresponding treatment is not sufficiently effective, and the experimental drug or placebo will be added to this treatment to evaluate the effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nalfurafine Hydrochloride 5μg | Experimental | Drug: Nalfurafine HydrochlorideOral administration after dinner, once daily for 14 consecutive days |
| Nalfurafine Hydrochloride 2.5μg | Experimental | Drug: Nalfurafine Hydrochloride+PlaceboOral administration after dinner, once daily for 14 consecutive days |
| Placebo | Placebo comparator | Drug: PlaceboOral administration after dinner, once daily for 14 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic renal failure patients who have been on stable dialysis for 3 months or more, receive regular hemodialysis 3 times a week, and expect no significant treatment changes or dramatic changes in their condition during the clinical trial;
- In the 1 year prior to signing the informed consent, patients who were treated with the following drugs A and/or B: (A) Systematic treatment (oral, injection, etc.) of "prescribed drugs for pruritus" (including antihistamines or antiallergic drugs) for more than 2 weeks consecutively; (B). Use of " prescribed drugs for pruritus" (ointments, etc.) or topical treatment of moisturizers prescribed by physicians;
- Patients who had received treatment in inclusion criteria (2) but did not respond;
- When signing the informed consent, the patient is older than 18 years old (including 18 years old), regardless of gender;
- During the observation period before administration (D8-14), the number of days for which the VAS values were measured at the time of getting up and going to bed should not be less than 5 days, and the average value of the larger VAS values in the morning and evening measurements should not be less than 50 mm;
Key exclusion criteria (14 listed)
- Malignant tumor patients;
- Patients with mental illness or mental retardation who cannot correctly understand the VAS score and describe their feelings;
- Patients with alanine aminotransferase (ALT), aspartate aminotransferase (AST) or glutamine transferase (GGT) or total bilirubin higher than twice the upper limit of normal value (ULN) at the screening stage;
- Patients currently suffering from atopic dermatitis or chronic urticaria;
- Patients allergic to opioids;
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 2.5μg*2 ; Oral administration after dinner, once daily for 14 consecutive days | Drug | Nalfurafine Hydrochloride 5μg |
| Nalfurafine Hydrochloride+PlaceboNalfurafine Hydrochloride 2.5μg+ A placebo pill; Oral administration after dinner, once daily for 14 consecutive days | Drug | Nalfurafine Hydrochloride 2.5μg |
| Placebotwo placebo pills; Oral administration after dinner, once daily for 14 consecutive days | Drug | Placebo |
Primary outcome
Variation in VAS of Nalfurafine Hydrochloride versus Placebo
Time frame: up to 38(+1) days
The Variation = the mean of the daily maximum VAS value during the observation period before administration(D8-14) - the mean of the daily maximum VAS value during the administration period (D25-31). Only the days on which the VAS values were recorded during the day and night were evaluated.
3 secondary outcomes
Variation in pruritus scores based on the Hsie-Kawashima pruritus severity assessment method
Time frame: up to 38(+1) days
Variation in nocturnal pruritus scores based on the Hsie-Kawashima pruritus severity assessment method (improvement of pruritus-induced sleep disorders).
Time frame: up to 38(+1) days
Improvement degree of VAS
Time frame: up to 38(+1) days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nalfurafine Hydrochloride in people with Uremic Pruritus, run by Shenyang Sunshine Pharmaceutical Co., LTD. 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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 28 Jan 2021. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Jianghua, Master (0571-87236992, chenjianghua@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in VAS of Nalfurafine Hydrochloride versus Placebo (time frame: up to 38(+1) days). 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 28 Jan 2021.