Genetics of Hyperuricemia Therapy in Hmong

NCT02371421 | Completed

• 1 other identifier: 1408M53223
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperuricemia, Gout

Outcome Measures

Primary Outcomes (2)

• Percent change from baseline in serum uric acid

  14 days

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

  Differences in mean AUC across genotype groups

  14 days

Secondary Outcomes (2)

• Percent change from baseline in Uric Acid Fractional Excretion

  14 days

• Percent change from baseline in Uric Acid Renal Clearance

  14 days

Study Arms (1)

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.

Drug: Allopurinol

Interventions

Allopurinol DRUG

Allopurinol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hmong (self-report) adulst with gout as evidenced by use of uric acid-reducing medication.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Hyperuricemia; Gout

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Robert J Straka, PharmD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: February 25, 2015
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

US (1)