Dotinurad for Gout
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test how effectively dotinurad lowers uric acid levels in people with gout, a painful joint condition caused by excess uric acid in the blood. Initially, the trial will compare dotinurad with a placebo (an inactive substance), after which all participants will take dotinurad. This trial suits those who have had gout for at least a year and have not found success with, or cannot use, other common treatments like allopurinol or febuxostat. As a Phase 2 trial, this research focuses on evaluating dotinurad's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that dotinurad is likely to be safe for humans?
Research has shown that dotinurad is generally safe for people with high uric acid levels. In several studies, participants tolerated dotinurad well, with no serious safety concerns or severe side effects reported. One study found that dotinurad did not cause any drug-related problems at any dose. Additionally, Japan approved dotinurad in 2020 for treating gout and high uric acid levels, supporting its safety. So far, no new safety issues have emerged with its use.12345
Why do researchers think this study treatment might be promising for gout?
Dotinurad is unique because it targets gout by helping the kidneys remove uric acid more effectively, which is different from many existing treatments like allopurinol that work by reducing uric acid production. Researchers are excited about dotinurad because it offers a novel mechanism of action that could be beneficial for patients who do not respond well to current therapies. Additionally, the potential for improved kidney function makes dotinurad an appealing option for those with specific health concerns related to traditional gout treatments.
What evidence suggests that dotinurad might be an effective treatment for gout?
Research has shown that dotinurad effectively lowers uric acid levels in the blood, which is crucial for treating gout. One study found that 55.5% of patients taking dotinurad reached a healthy uric acid level within 12 weeks. Another study showed that a daily dose of 4 mg of dotinurad was more effective than febuxostat, another gout medication, in reaching target uric acid levels by week 24. Dotinurad is also well-tolerated, causing few side effects. In this trial, participants will either receive dotinurad throughout the study or start with a placebo before switching to dotinurad. Overall, the evidence suggests that dotinurad could be a promising option for managing gout.12467
Are You a Good Fit for This Trial?
This trial is for adults aged 18–75 with gout who can't tolerate or didn't respond to common gout medicines (allopurinol, febuxostat, or uricase). Participants must have moderately high uric acid levels and agree to use birth control if they can have children.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive dotinurad or placebo for 24 weeks
Treatment Period 2
Participants continue with dotinurad for an additional 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dotinurad
Trial Overview
The study compares dotinurad, a new medicine meant to lower uric acid in the blood, against a placebo. People are randomly assigned to either group and will be treated for about 24 weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
The Treatment Period will consist of 2 consecutive parts: a 24-week period where participants will take placebo (Treatment Period 1) followed by a 12-week treatment period where participants will take dotinurad (Treatment Period 2).
The Treatment Period will consist of 2 consecutive parts: a 24-week period where participants will take dotinurad (Treatment Period 1) followed by a 12-week period where participants will continue to take dotinurad (Treatment Period 2).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Crystalys Therapeutics
Lead Sponsor
Citations
Efficacy and Safety of Dotinurad Versus Febuxostat for ... - PMC
Dotinurad 4 mg/day was superior to febuxostat 40 mg/day in achieving serum urate levels ≤6.0 mg/dL at week 24 and was well tolerated in Chinese patients with ...
“URECE®” (Dotinurad) Launched in China as a treatment ...
For the secondary endpoint, the proportion of patients with SUA ≤6.0 mg/dL at 12 weeks was 55.5% in the dotinurad group and 50.5% in the ...
Dotinurad Treatment for Patients With Hyperuricemia ...
Dotinurad therapy may be well-tolerated in patients with hyperuricemia and may have efficacy comparable with existing standard treatment in patients with CKD ...
POS0255 A RANDOMIZED, MULTICENTER, DOUBLE ...
Conclusion: Dotinurad 4 mg demonstrated superiority to febuxostat 40 mg in lowering SUA and dotinurad 2 mg was non-inferior to febuxostat 40mg in Chinese ...
Dotinurad: a novel selective urate reabsorption inhibitor for ...
At a maintenance dose of 2 or 4 mg once daily, most patients achieved the target serum urate level of ≤6 mg/dL in a long-term study. No findings that raised ...
Urica Therapeutics Announces Topline Data From Phase 1 ...
Dotinurad was shown to be safe and well tolerated with no severe adverse events observed at any dose level. No drug-related adverse events were ...
Comparative assessment of the effects of dotinurad and ...
This study investigated the efficacy of dotinurad to reduce serum UA levels and its effects on renal function and compared those effects with those of XOIs.
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