HyperuricemiaPhase 2NCT03185793
Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia
A Phase 2 study testing SHR4640 and benzbromarone in people with Hyperuricemia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The objective of the study is to assess efficacy and safety of SHR4640 in subjects with hyperuricemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- SHR4640 and benzbromarone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2017to 20 Jul 2018
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years, male or female;
- Subject meets one of the following conditions:
- 1) Subject with a history of gout has a serum uric acid ≥480μmol/l at screening; 2) Subject with a history of hyperuricemia has a serum uric acid ≥540μmol/l at screening, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3) Subject with a history of hyperuricemia has a serum uric acid≥480μmol/l at screening, on stable treatment for hypertensive, hyperlipidemia or diabetes for at least 3 month, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3. 18kg/m2≤ BMI ≤32kg/m2.
Who cannot join
- Subject who is pregnant or breastfeeding;
- Alanine aminotransferase or Aspartate aminotransferase or total bilirubin>1.5 upper normal limit;
- Estimated glomerular filtration rate (MDRD formula) ˂60ml/min;
- HbA1c˃8%;
- Subject with known hypersensitivity or allergy to SHR4640 or any component of SHR4640;
- Subject with a history of malignancy;
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- Subject with a history of urolithiasis, or positive findings on ultrasound examination at screen
- Subject within the last 3months has: myocardial infarction, angina, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemia attack;
- Subject has acute gout flares within 2 weeks before randomization;
- Subject who is taking any other urate-lowering medication (allopurinol, febuxostat, probenecid and benzbromarone) that is indicated within 2 weeks before randomization and can not stop during the study;
- Subject who is taking more than 100mg once daily or unstable dosage aspirin within 2 weeks before randomization and can not stop during the study;
- Subject who is taking any diuretic within 2 weeks before randomization and can not stop during the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Hengrui Medicine Co., Ltd.
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia (Asymptomatic and Gout)
The objective of the study is to assess efficacy and safety of SHR4640 in subjects with hyperuricemia.
- Conditions
- Hyperuricemia
- Being tested
- Placebo, SHR4640, benzbromarone
- Keywords
- SHR4640, Phase II, monotherapy, dose-finding
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo once daily for 5 weeks
SHR4640Drug
1mg SHR4640 once daily for a week, 2.5mg, 5mg or 10mg SHR4640 once daily for 4 weeks
benzbromaroneDrug
25mg benzbromarone once daily for a week, 50mg benzbromarone once daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo for 5 weeks Receives: Drug: Placebo |
| 2.5mg SHR4640 | Experimental | SHR4640 for 5 weeks Receives: Drug: SHR4640 |
| 5mg SHR4640 | Experimental | SHR4640 for 5 weeks Receives: Drug: SHR4640 |
| 10mg SHR4640 | Experimental | SHR4640 for 5 weeks Receives: Drug: SHR4640 |
| 50mg benzbromarone | Active comparator | Benzbromarone for 5 weeks Receives: Drug: benzbromarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with a serum uric level≤360μmol/l.
Measured: Week 5
Secondary outcomes (8)
Actual change from baseline in serum uric level.
Measured: Week 5
Percentage change from baseline in serum uric level .
Measured: Week 5
Rate of gout flares requiring treatment.
Measured: Up to week 5
Incidence of gout flares requiring treatment.
Measured: Up to week 5
Proportion of subjects with a serum uric level≤360μmol/l
Measured: At week1, 2, 3 and 4
Proportion of subjects with a serum uric level consistent ≤360μmol/l
Measured: At week 3, 4 and 5
Actual change from baseline in serum uric level
Measured: At week 1, 2, 3 and 4
Percentage change from baseline in serum uric level
Measured: At week 1, 2, 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start20 Jul 2017
- Primary completion20 Jul 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chunde Bao, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185793
- Sponsor's protocol ID
- SHR4640-201
- Status last verified
- Aug 2019
- First submitted
- 12 Jun 2017
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin Y, Chen X, Ding H, Ye P, Gu J, Wang X, Jiang Z, Li D, Wang Z, Long W, Li Z, Jiang G, Li X, Bi L, Jiang L, Wu J, Guo L, Cai X, Lu X, Chen Q, Chen H, Peng A, Zuo X, Ning R, Zhang Z, Tai Y, Zhang T, Bao C. Efficacy and safety of a selective URAT1 inhibitor SHR4640 in Chinese subjects with hyperuricaemia: a randomized controlled phase II study. Rheumatology (Oxford). 2021 Nov 3;60(11):5089-5097. doi: 10.1093/rheumatology/keab198.
PubMed 33693494
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia (Asymptomatic and Gout)
- ClinicalTrials.gov ID
- NCT03185793
- Acronym / sponsor ID
- SHR4640-201
- Conditions
- Hyperuricemia
- Keywords
- SHR4640, Phase II, monotherapy, dose-finding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 14 Jun 2017 (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 objective of the study is to assess efficacy and safety of SHR4640 in subjects with hyperuricemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placeboplacebo for 5 weeks |
| 2.5mg SHR4640 | Experimental | Drug: SHR4640SHR4640 for 5 weeks |
| 5mg SHR4640 | Experimental | Drug: SHR4640SHR4640 for 5 weeks |
| 10mg SHR4640 | Experimental | Drug: SHR4640SHR4640 for 5 weeks |
| 50mg benzbromarone | Active comparator | Drug: benzbromaroneBenzbromarone for 5 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-70 years, male or female;
- Subject meets one of the following conditions:
- 1) Subject with a history of gout has a serum uric acid ≥480μmol/l at screening; 2) Subject with a history of hyperuricemia has a serum uric acid ≥540μmol/l at screening, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3) Subject with a history of hyperuricemia has a serum uric acid≥480μmol/l at screening, on stable treatment for hypertensive, hyperlipidemia or diabetes for at least 3 month, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3. 18kg/m2≤ BMI ≤32kg/m2.
Key exclusion criteria (12 listed)
- Subject who is pregnant or breastfeeding;
- Alanine aminotransferase or Aspartate aminotransferase or total bilirubin>1.5 upper normal limit;
- Estimated glomerular filtration rate (MDRD formula) ˂60ml/min;
- HbA1c˃8%;
- Subject with known hypersensitivity or allergy to SHR4640 or any component of SHR4640;
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 |
|---|---|---|
| PlaceboPlacebo once daily for 5 weeks | Drug | Placebo |
| SHR46401mg SHR4640 once daily for a week, 2.5mg, 5mg or 10mg SHR4640 once daily for 4 weeks | Drug | 10mg SHR4640, 2.5mg SHR4640, 5mg SHR4640 |
| benzbromarone25mg benzbromarone once daily for a week, 50mg benzbromarone once daily for 4 weeks | Drug | 50mg benzbromarone |
Primary outcome
Proportion of subjects with a serum uric level≤360μmol/l.
Time frame: Week 5
8 secondary outcomes
Actual change from baseline in serum uric level.
Time frame: Week 5
Percentage change from baseline in serum uric level .
Time frame: Week 5
Rate of gout flares requiring treatment.
Time frame: Up to week 5
Incidence of gout flares requiring treatment.
Time frame: Up to week 5
Proportion of subjects with a serum uric level≤360μmol/l
Time frame: At week1, 2, 3 and 4
Proportion of subjects with a serum uric level consistent ≤360μmol/l
Time frame: At week 3, 4 and 5
Actual change from baseline in serum uric level
Time frame: At week 1, 2, 3 and 4
Percentage change from baseline in serum uric level
Time frame: At week 1, 2, 3 and 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Derived from this study: PubMed 33693494Lin Y, Chen X, Ding H, Ye P, Gu J, Wang X, Jiang Z, Li D, Wang Z, Long W, Li Z, Jiang G, Li X, Bi L, Jiang L, Wu J, Guo L, Cai X, Lu X, Chen Q, Chen H, Peng A, Zuo X, Ning R, Zhang Z, Tai Y, Zhang T, Bao C. Efficacy and safety of a selective URAT1 inhibitor SHR4640 in Chinese subjects with hyperuricaemia: a randomized controlled phase II study. Rheumatology (Oxford). 2021 Nov 3;60(11):5089-5097. doi: 10.1093/rheumatology/keab198.
- 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.
Chunde Bao principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR4640 and benzbromarone in people with Hyperuricemia, run by Jiangsu HengRui Medicine 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 3 inclusion and 12 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: finished, as of the sponsor's last update on 7 Aug 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with a serum uric level≤360μmol/l. (time frame: Week 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03185793, which also lists 1 linked publication.
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 7 Aug 2019.