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Completed

NCT Number: NCT02371421

Genetics of Hyperuricemia Therapy in Hmong

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.

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Key information

Conditions

Hyperuricemia, Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout Hyperuricemia Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Allopurinol

Drug

Primary outcomes

  1. Percent change from baseline in serum uric acid

    Time frame: 14 days

  2. Steady state oxipurniol area under the serum concentration-time curve (AUC)

    Time frame: 14 days

    Differences in mean AUC across genotype groups

Secondary outcomes

  1. Percent change from baseline in Uric Acid Fractional Excretion

    Time frame: 14 days

  2. Percent change from baseline in Uric Acid Renal Clearance

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Acronym: GOUT-H

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Feb 25, 2015
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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