Uremic PruritusPhase 3NCT06446310
Phase 3 Study of QLG2198 in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
A Phase 3 study testing QLG2198 in people with Uremic Pruritus, run by Qilu Pharmaceutical (Hainan) Co., Ltd. at 3 sites in China.
Trial summary
This a multicentre study that consists of a 12-week double-blind period, and a 14-week open-label extension period and a 1-week follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Uremic Pruritus
- What is being tested?
- QLG2198
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 3 sitesChina
- Study dates
- 18 Jun 2024to 3 Aug 2025
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with chronic kidney disease (CKD) on HD 3 times weekly for ≥12 weeks prior to screening who can continue HD without changing its frequency or method
- If female, is not pregnant, or nursing.
- agrees not to donate sperm or egg after the first dose of investigational product administration until 7 days after the last dose of investigational product, and agrees to use contraceptive method 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
Who cannot join
- Planned 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 treatment .
- 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 or drug abuse/dependence within 12 months prior to screening.
- New or change of treatment received for itch within 2 weeks prior to screening.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Zuo LI, zuolimd@hotmail.com
- Recruiting
Jieyang People's Hospital
Jieyang, Guangdong
Liu Qinghua
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong
Wang Rong, wrjlsd@163.com
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase 3, Clinical Study of QLG2198 in Haemodialysis Adult Subjects With Moderate-to-Severe Pruritus
This a multicentre study that consists of a 12-week double-blind period, and a 14-week open-label extension period and a 1-week follow-up period.
Read the detailed description
Total study duration for a single subject is 31 to 32 weeks with a 4-week screening period, a 12-week double-blind period, a 14-week open-label extension period, and a 1-week follow-up period.
QLG2198 will be administered in the double-blind and open-label period 3 times a week at the end of each dialysis session. The total dose of the investigational product will be determined based on the subject's prescription dry body weight.
The primary objective of the study is:
To evaluate the efficacy and safety of QLG2198 0.5 μg/kg compared to placebo in reducing the intensity of itch in HD subjects with moderate-to-severe pruritus.
- Conditions
- Uremic Pruritus
- Being tested
- QLG2198, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLG2198Drug
Participants receive QLG2198 three times a week (0,5 micrograms/kg dry body weight). QLG21988 is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis.
PlaceboDrug
Participants receive Placebo three times a week (0,5 micrograms/kg dry body weight). Placebo is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis
| Study group | Role | What they receive |
|---|---|---|
| 12-weeks double-blind period-QLG2198 | Experimental | Interventions:
Drug: QLG2198 Injection Receives: Drug: QLG2198 |
| 12-weeks double-blind period- placebo | Placebo comparator | Interventions:
Drug: Placebo Injection Receives: Drug: Placebo |
| 14-weeks open-label period following the double-blind period- QLG2198 | Experimental | Interventions:
Drug: QLG2198 Injection Receives: Drug: QLG2198 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the weekly mean of the Worst Itch Numeric Rating Scale (WI-NRS) score
The degree of the most intense itching within a day will be assessed using Worst Itch Numeric Rating Scale (WI-NRS) scores.patients will be asked to indicate the intensity of the worst itching they experienced over the past 24 hours by marking one of 11 numbers, from 0 to 10, that best describes it, where "0" is labeled with the anchor phrase "no itching" and "10" is labeled "worst itching imaginable."
Measured: Week 4 of double-blind period
Secondary outcomes (5)
Proportion of subjects achieving ≥3-point improvement from baseline with respect to the weekly mean of the WI-NRS
The degree of the most intense itching within a day will be assessed using Worst Itch Numeric Rating Scale (WI-NRS) scores.
Measured: Week 4 、Week 8、 Week 12 of double-blind period
Proportion of subjects achieving ≥4-point improvement from baseline with respect to the weekly mean of the WI-NRS
The degree of the most intense itching within a day will be assessed using Worst Itch Numeric Rating Scale (WI-NRS) scores.
Measured: Week 4 、Week 8、 Week 12 of double-blind period
Change from baseline in itch-related Quality of Life (QoL) assessed by the 5-D itch scale total score
The 5-D itch scale is a questionnaire where patients assess the 5 dimensions of itch (degree, duration, direction, disability, and distribution).The total score is the sum of the numeric value of each answered question.
Measured: Week 4 、Week 8、Week 12 of double-blind period,Week 4 、Week 8、Week 12 、Week 15 of open-label extension period
Change from baseline in itch-related QoL assessed by the Skindex-10 scale total score
The Skindex-10 scale is a questionnaire that measures QoL in relationship to the itch intensity.Patients are asked to mark 1 of 7 boxes numbered from 0(labeled with the anchor phrase "never bothered") to 6 (labeled as "always bothered") for each of the 10 questions describing how often they have been bothered by their itch and its impact over the past week. The total score is the sum of the numeric value of each answered question. The total score is subdivided into 3 domain scores, which are sums of the scores of the following questions: disease domain (questions 1 to 3),mood/emotional distress domain (questions 4 to 6), and social functioning domain (questions 7 to 10).
Measured: Week 4 、Week 8、 Week 12 of double-blind period,Week 4 、Week 8、Week 12 、Week 15 of open-label extension period
Patient Global Impression of Change
The Patient Global Impression of Change is a questionnaire that assesses the change in itch compared to the itch at the start of the study.The scale has only 1 item, and the patient is asked to mark the category that best describes the change in itch ranging from "Very Much Improved" to"Very Much Worse"
Measured: End of double-blind period, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start18 Jun 2024
- Primary completion21 Feb 2025 (estimated)
- Study completion3 Aug 2025 (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.
- 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
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical (Hainan) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zuo Li, Principal investigator, Peking University People's HospitalWang Rong, Principal investigator, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446310
- Sponsor's protocol ID
- QLG2198-301
- Status last verified
- May 2024
- First submitted
- 31 May 2024
- Last updated
- 21 Jun 2024
- 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase 3, Clinical Study of QLG2198 in Haemodialysis Adult Subjects With Moderate-to-Severe Pruritus
- ClinicalTrials.gov ID
- NCT06446310
- Acronym / sponsor ID
- QLG2198-301
- Conditions
- Uremic Pruritus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical (Hainan) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 21 Feb 2025 (estimated)
- Study completion
- 3 Aug 2025 (estimated)
- First posted
- 6 Jun 2024 (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 a multicentre study that consists of a 12-week double-blind period, and a 14-week open-label extension period and a 1-week follow-up period.
Detailed description
Total study duration for a single subject is 31 to 32 weeks with a 4-week screening period, a 12-week double-blind period, a 14-week open-label extension period, and a 1-week follow-up period.
QLG2198 will be administered in the double-blind and open-label period 3 times a week at the end of each dialysis session. The total dose of the investigational product will be determined based on the subject's prescription dry body weight.
The primary objective of the study is:
To evaluate the efficacy and safety of QLG2198 0.5 μg/kg compared to placebo in reducing the intensity of itch in HD subjects with moderate-to-severe pruritus.
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 |
|---|---|---|
| 12-weeks double-blind period-QLG2198 | Experimental | Drug: QLG2198Interventions: Drug: QLG2198 Injection |
| 12-weeks double-blind period- placebo | Placebo comparator | Drug: PlaceboInterventions: Drug: Placebo Injection |
| 14-weeks open-label period following the double-blind period- QLG2198 | Experimental | Drug: QLG2198Interventions: Drug: QLG2198 Injection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with chronic kidney disease (CKD) on HD 3 times weekly for ≥12 weeks prior to screening who can continue HD without changing its frequency or method
- If female, is not pregnant, or nursing.
- agrees not to donate sperm or egg after the first dose of investigational product administration until 7 days after the last dose of investigational product, and agrees to use contraceptive method 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
Key exclusion criteria (8 listed)
- Planned 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 treatment .
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 |
|---|---|---|
| QLG2198Participants receive QLG2198 three times a week (0,5 micrograms/kg dry body weight). QLG21988 is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis. | Drug | 12-weeks double-blind period-QLG2198, 14-weeks open-label period following the double-blind period- QLG2198 |
| PlaceboParticipants receive Placebo three times a week (0,5 micrograms/kg dry body weight). Placebo is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis | Drug | 12-weeks double-blind period- placebo |
Primary outcome
Change from baseline in the weekly mean of the Worst Itch Numeric Rating Scale (WI-NRS) score
Time frame: Week 4 of double-blind period
The degree of the most intense itching within a day will be assessed using Worst Itch Numeric Rating Scale (WI-NRS) scores.patients will be asked to indicate the intensity of the worst itching they experienced over the past 24 hours by marking one of 11 numbers, from 0 to 10, that best describes it, where "0" is labeled with the anchor phrase "no itching" and "10" is labeled "worst itching imaginable."
5 secondary outcomes
Proportion of subjects achieving ≥3-point improvement from baseline with respect to the weekly mean of the WI-NRS
Time frame: Week 4 、Week 8、 Week 12 of double-blind period
Proportion of subjects achieving ≥4-point improvement from baseline with respect to the weekly mean of the WI-NRS
Time frame: Week 4 、Week 8、 Week 12 of double-blind period
Change from baseline in itch-related Quality of Life (QoL) assessed by the 5-D itch scale total score
Time frame: Week 4 、Week 8、Week 12 of double-blind period,Week 4 、Week 8、Week 12 、Week 15 of open-label extension period
Change from baseline in itch-related QoL assessed by the Skindex-10 scale total score
Time frame: Week 4 、Week 8、 Week 12 of double-blind period,Week 4 、Week 8、Week 12 、Week 15 of open-label extension period
Patient Global Impression of Change
Time frame: End of double-blind period, week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Uremic Pruritus
Active, not recruitingObservational study
Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls
End-Stage Kidney Disease (ESKD), 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. This study is not recruiting at the moment.
Zuo Li principal investigator
Peking University People's Hospital
Wang Rong principal investigator
Shandong Provincial Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QLG2198 in people with Uremic Pruritus, run by Qilu Pharmaceutical (Hainan) Co., Ltd. at 3 sites 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 4 inclusion and 8 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 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Wu Yidi, M.M (16653176910, yidi.wu@qilu-pharma.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 the weekly mean of the Worst Itch Numeric Rating Scale (WI-NRS) score (time frame: Week 4 of double-blind period). 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 21 Jun 2024.