Genetics of Hyperuricemia Therapy in Hmong

NCT ID: NCT02371421

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-12-31

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Allopurinol

Intervention Type: DRUG

Interventions

Allopurinol

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert J Straka, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1408M53223

Identifier Type: -

Identifier Source: org_study_id