Genetics of Hyperuricemia Therapy in Hmong | NCT02371421

Studies
Genetics of Hyperuricemia Therapy in Hmong

NCT02371421

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Jul 15, 2019Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Hyperuricemia, Gout

Interventions

Allopurinol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014Actual

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2016Actual

First Submitted Date

Feb 19, 2015

First Submission Date that Met QC Criteria

Feb 24, 2015

First Posted Date

Feb 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2019

Last Update Posted Date

Jul 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Allopurinol	Drug		Allopurinol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Percent change from baseline in Uric Acid Fractional Excretion		14 days
Percent change from baseline in Uric Acid Renal Clearance		14 days

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert J Straka, PharmD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Minneapolis	Minnesota	55455	United States

Condition Browse Module

MeSH Terms

ID	Term
D033461	Hyperuricemia
D006073	Gout

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D001168	Arthritis
D007592	Joint Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000493	Allopurinol

Ancestor Terms

ID	Term
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided