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Xanthine Oxidase Inhibitor

Treat-to-Target vs Symptom Management for Gout (TRUST Trial)

Phase 4

Recruiting

Led By Hyon K Choi, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to two years of follow up

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Approved for 10 Other Conditions

All Individual Drugs Already Approved

Summary

"This trial is comparing two different treatments for gout to see which one is better for patients in terms of gout symptoms and other related health issues like heart, metabolism, and kidney problems."

Who is the study for?

This trial is for adults aged 18-90 with chronic kidney disease stage 3B or worse, at least one gout flare in the past year, and high serum urate levels. They must have had two episodes of renal colic within five years and more than one tophus. Participants need to be able to swallow pills and agree to birth control measures if applicable.

What is being tested?

The TRUST study compares two gout treatment strategies: Treat-to-Target Serum Urate (TTT) versus Treat-to-Avoid Symptoms (TTASx). It aims to find out which approach is better for patient-centered outcomes and cardiovascular-metabolic-renal health.

What are the potential side effects?

Possible side effects include stomach issues from Naproxen, digestive problems from Colchicine, mood swings or increased appetite from Prednisone, and skin reactions or liver issues from Allopurinol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to two years of follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to two years of follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to two years of follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of gout flare

Secondary study objectives

Quality of life assessment

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Active Control

Group I: TTASxActive Control5 Interventions

Subjects randomized to the treat-to-avoid-symptoms (TTASx) group will receive the same education as the TTT-SU group. In addition, they will receive anti-inflammatory treatments (naproxen, colchicine, and/or prednisone); enough to treat up to six flares over the ensuing three months.

Group II: TTT-SUActive Control3 Interventions

The participants randomized to the Treat-to-Target-Serum Urate (TTT-SU) group will be counseled about gout, generalized lifestyle and dietary issues and will be provided with a three-month supply of allopurinol as well as a treatment to prophylax against attacks that might occur during the up-titration of urate lowering therapy. Allopurinol dose increases will occur until SU concentrations achieve a target level \< 6.0 mg/dL.

Do I qualify?Apply below to find out