Gout study: Dotinurad
Official title A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants
ClinicalTrials.gov ID: NCT07535034
What this study is testing
What is Dotinurad?
This is an investigational oral tablet being studied as a potential treatment for gout. It is designed to help the kidneys remove uric acid from the body.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if dotinurad effectively lowers the level of uric acid in the blood after 24 weeks.
- Who it's for
- The study is looking for people with gout who cannot tolerate standard uric acid-lowering drugs or whose previous treatment with uricase did not work.
- What's involved
- Participants will take the study drug dotinurad and undergo tests to measure their uric acid levels.
- Time commitment
- The study lasts for 24 weeks, requiring participants to attend visits for testing.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
- History (either by medical record or participant interview) of intolerance or a contraindication to either allopurinol or febuxostat.
- Failed uricase treatment (eg, an sUA level \>6.0 mg/dL at least 2 weeks after last infusion; intolerant or contraindicated to uricase treatment).
- sUA level \>6.0 and \<10.5 mg/dL at both Screening Visit 1 (Day -28 Visit) and Screening Visit 2 (Day -7 Visit).
- Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -28 Visit), a negative urine...
You likely can't join if
- History of or presence of kidney stones within 1 year prior to Screening.
- History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.
- Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.
- Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) during...
- Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise...
See the full eligibility criteria
- Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
- History (either by medical record or participant interview) of intolerance or a contraindication to either allopurinol or febuxostat.
- Failed uricase treatment (eg, an sUA level \>6.0 mg/dL at least 2 weeks after last infusion; intolerant or contraindicated to uricase treatment).
- sUA level \>6.0 and \<10.5 mg/dL at both Screening Visit 1 (Day -28 Visit) and Screening Visit 2 (Day -7 Visit).
- Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -28 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding.
- Fertile male participants and female participants of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use acceptable contraception from the time of signing informed consent...
- History of or presence of kidney stones within 1 year prior to Screening.
- History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.
- Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.
- Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) during Screening.
- Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or trial compliance or may confound interpretation of trial...
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Granada Hills, California, United States
- Thousand Oaks, California, United States
- Tustin, California, United States
- Denver, Colorado, United States
- DeBary, Florida, United States
- Flagami, Florida, United States
- Hialeah, Florida, United States
- Jupiter, Florida, United States
- Lakeland, Florida, United States
- Margate, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Lexington, Kentucky, United States
- Oxon Hill, Maryland, United States
- Rockville, Maryland, United States
- Saint Clair Shores, Michigan, United States
+ 20 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Granada Hills, California, United States; Thousand Oaks, California, United States; Tustin, California, United States and 34 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.