Recruiting

Uric Acid Management

Sponsor:

VA Office of Research and Development

Code:

NCT06887452

Conditions

Gout

Gouty Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pharmacist-Led

Study Details

Brief summary:

This study will compare two different approaches to manage medications that lower uric acid levels. This study will be conducted at five VA medical centers across the United States and will take 4-5 years to complete. Individual participation will last up to two years.

Conditions

Gout

Gouty Arthritis

Study ID

NCT06887452

Start date

Oct 1, 2026

Status verified date

Oct, 2026

Completion date

Mar 30, 2031

Anticipated

Primary completion date

Oct 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • US Veterans with physician-diagnosed
  • Documented hyperuricemia (SU > 6.8 milligrams per deciliter)
  • Satisfy American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) gout classification criteria
  • Report 1 or more flares in the prior 6 months
  • Receipt of a new urate-lowering therapy (ULT) prescription (allopurinol or febuxostat) initiated by a primary care provider or longer term ULT but otherwise satisfy the flare/SU criteria

Exclusion Criteria:

  • Any patient intolerant or unable to take urate-lowering therapies (allopurinol or febuxostat)
  • Patients with a rheumatology encounter within the prior 3 months
  • Patients on an allopurinol dose > 300 or a Febuxostat dose > 40
  • Patients with stage IV/V Chronic Kidney Disease (CKD)
  • Patients with a life expectancy < 12 months
  • Patients with a concomitant medication of azathioprine or 6-MPC (urate-lowering therapy contraindicated)

Study Design

Enrollment

310 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pharmacist-Led

Veterans will participate in regular telehealth visits with study pharmacists. Serum urate lab tests will be ordered during dose escalation phase of gout treatment.

no intervention: Usual care

Veterans will receive standard care from their primary care provider for the management of their gout.

Interventions

Pharmacist-Led

Pharmacist will conduct regular telehealth visits with Veterans during dose escalation phase of gout treatment

Primary outcome measure

  • flare occurrence [ Time Frame: during year two ]
  • serum urate at goal [ Time Frame: at end of year one ]

Central Contacts and Locations

Central contacts

Bridget Kramer

(402) 995-3206bridget.kramer@va.gov

Locations

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Recruiting

Omaha, Nebraska, United States, 68105-1850

Contacts

Bridget Kramer

(402) 995-3206bridget.kramer@va.gov

Principal Investigator:

Ted R. Mikuls

VA Portland Health Care System, Portland, OR

Recruiting

Portland, Oregon, United States, 97207-2964

Contacts

Alexandra Bennett

503-220-8262alexandra.bennett@va.gov

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Recruiting

Philadelphia, Pennsylvania, United States, 19104-4551

Contacts

Criswell Lavery, MPH

215-823-5800criswell.lavery@va.gov

VA Salt Lake City Health Care System, Salt Lake City, UT

Recruiting

Salt Lake City, Utah, United States, 84148-0001

Contacts

Jennifer Godina

jennifer.godina1@va.gov

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Recruiting

Seattle, Washington, United States, 98108-1532

Contacts

Hannah Brubeck

206-764-2673hannah.brubeck@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.