Clinical Trial: Genetics of Hyperuricemia Therapy in Hmong

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Genomic Guided Assessment of Drug Therapy Effectiveness in Managing Hmong Adults With Hyperuricemia or Gout.

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 Summary: 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.
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: February 19, 2015
Date Started: June 2014
Date Completion:
Last Updated: February 9, 2017
Last Verified: February 2017