Genomic Guided Assessment of Drug Therapy Effectiveness in Managing Hmong Adults With Hyperuricemia or Gout.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percent change from baseline in serum uric acid
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Allopurinol (Drug)
结局指标
主要结局
Percent change from baseline in serum uric acid
时间窗: 14 days
Steady state oxipurniol area under the serum concentration-time curve (AUC)
时间窗: 14 days
Differences in mean AUC across genotype groups
次要结局
- Percent change from baseline in Uric Acid Fractional Excretion(14 days)
- Percent change from baseline in Uric Acid Renal Clearance(14 days)