Hyperuricemia, GoutGOUT-HNCT02371421
Genetics of Hyperuricemia Therapy in Hmong
An observational study of Hyperuricemia, Gout, run by University of Minnesota at 1 site in United States.
Trial summary
To pursue this objective, we will be measuring uric acid at baseline and post 14 days of twice daily allopurinol therapy in 30 Hmong participants with documented gout or hyperuricemia and known genotype for key renal transporters of uric acid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperuricemia, Gout
- What is being tested?
- Allopurinol
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2016
- Phase
- Observational
- 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
Study population: Hmong (self-report) adulst with gout as evidenced by use of uric acid-reducing medication.
Who may be able to join
- Both parents are Hmong (self report)
- Self report history of gout, or
- History (within one year) of active use of xanthine oxidase inhibitors, or
- Evidence of serum uric acid ≥ 6mg/dL , or
- Serum uric acid < 6mg/dL with history of ≥ 2 gout episodes within the last 6 months
- Ability to provide informed consent for participation in the study
- Demonstrate understanding of the study procedures and ability to comply with the study drug for the entire length of the study
- Ability to obtain permission from treating clinician to allow stopping the drug for 10 days
Who cannot join
- Pregnant women or women of childbearing age sexually active and not using any contraception
- estimated creatinine clearance (eCrCl) <30ml/min
- Elevated liver enzymes (3 x upper normal limit of liver function tests (AST and ALT))
- Contraindication to receiving allopurinol
- Active participation in other clinical trial (or within 30 days)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Genomic Guided Assessment of Drug Therapy Effectiveness in Managing Hmong Adults With Hyperuricemia or Gout.
To pursue this objective, we will be measuring uric acid at baseline and post 14 days of twice daily allopurinol therapy in 30 Hmong participants with documented gout or hyperuricemia and known genotype for key renal transporters of uric acid.
Read the detailed description
Minnesota Hmong are a unique population of individuals of South East Asian descent who have been noted to have a higher prevalence of gout and gout related comorbidities compared to non-Hmong. Elevated levels of uric acid are thought to be at the root cause of gout. Elevated levels of serum uric acid can result from either overproduction and or under-excretion. Xanthine oxidase plays a key role in the breakdown of purines to form uric acid. Transporters in the kidney also play a key role in excretion and/or re-absorption of uric acid. The objective of this study is to explore whether genetic variations in renal transporters may influence the disposition of serum uric acid in response to a drug (allopurinol) as well as the disposition of its active metabolite (oxipurinol) which may also be a substrate for these same transporters responsible for uric acid disposition. Genetic variations unique to the Hmong population may explain their increased prevalence in gout and or perceived lack of responsiveness to the drug (allopurinol) used to treat the condition.
- Conditions
- Hyperuricemia, Gout
- Being tested
- Allopurinol
- Medical subject headings
- Hyperuricemia, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol | Participants with history of gout indicated by the use of allopurinol or participants who have high serum uric acid without contraindication to use allopurinol. Receives: Drug: Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in serum uric acid
Measured: 14 days
Steady state oxipurniol area under the serum concentration-time curve (AUC)
Differences in mean AUC across genotype groups
Measured: 14 days
Secondary outcomes (2)
Percent change from baseline in Uric Acid Fractional Excretion
Measured: 14 days
Percent change from baseline in Uric Acid Renal Clearance
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperuricemia, GoutStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert J Straka, PharmD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371421
- Sponsor's protocol ID
- 1408M53223
- Acronym
- GOUT-H
- Status last verified
- Jul 2019
- First submitted
- 19 Feb 2015
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Guided Assessment of Drug Therapy Effectiveness in Managing Hmong Adults With Hyperuricemia or Gout.
- ClinicalTrials.gov ID
- NCT02371421
- Acronym / sponsor ID
- GOUT-H / 1408M53223
- Conditions
- Hyperuricemia, Gout
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Feb 2015 (estimated)
- 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.
To pursue this objective, we will be measuring uric acid at baseline and post 14 days of twice daily allopurinol therapy in 30 Hmong participants with documented gout or hyperuricemia and known genotype for key renal transporters of uric acid.
Detailed description
Minnesota Hmong are a unique population of individuals of South East Asian descent who have been noted to have a higher prevalence of gout and gout related comorbidities compared to non-Hmong. Elevated levels of uric acid are thought to be at the root cause of gout. Elevated levels of serum uric acid can result from either overproduction and or under-excretion. Xanthine oxidase plays a key role in the breakdown of purines to form uric acid. Transporters in the kidney also play a key role in excretion and/or re-absorption of uric acid. The objective of this study is to explore whether genetic variations in renal transporters may influence the disposition of serum uric acid in response to a drug (allopurinol) as well as the disposition of its active metabolite (oxipurinol) which may also be a substrate for these same transporters responsible for uric acid disposition. Genetic variations unique to the Hmong population may explain their increased prevalence in gout and or perceived lack of responsiveness to the drug (allopurinol) used to treat the condition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allopurinol | – | Drug: AllopurinolParticipants with history of gout indicated by the use of allopurinol or participants who have high serum uric acid without contraindication to use allopurinol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hmong (self-report) adulst with gout as evidenced by use of uric acid-reducing medication.
Key inclusion criteria (8 listed)
- Both parents are Hmong (self report)
- Self report history of gout, or
- History (within one year) of active use of xanthine oxidase inhibitors, or
- Evidence of serum uric acid ≥ 6mg/dL , or
- Serum uric acid < 6mg/dL with history of ≥ 2 gout episodes within the last 6 months
Key exclusion criteria (5 listed)
- Pregnant women or women of childbearing age sexually active and not using any contraception
- estimated creatinine clearance (eCrCl) <30ml/min
- Elevated liver enzymes (3 x upper normal limit of liver function tests (AST and ALT))
- Contraindication to receiving allopurinol
- Active participation in other clinical trial (or within 30 days)
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 |
|---|---|---|
| Allopurinol | Drug | Allopurinol |
Primary outcome
Percent change from baseline in serum uric acid
Time frame: 14 days
Steady state oxipurniol area under the serum concentration-time curve (AUC)
Time frame: 14 days
Differences in mean AUC across genotype groups
2 secondary outcomes
Percent change from baseline in Uric Acid Fractional Excretion
Time frame: 14 days
Percent change from baseline in Uric Acid Renal Clearance
Time frame: 14 days
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 15 Jul 2019.
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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.
Robert J Straka, PharmD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperuricemia, Gout, run by University of Minnesota at 1 site in United States.
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 8 inclusion and 5 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 15 Jul 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Percent change from baseline in serum uric acid (time frame: 14 days). The study lists 2 primary outcomes in all. 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 15 Jul 2019; AzTrials last refreshed its copy on 6 Nov 2026.