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One infusion, two targets: a uric-acid-lowering drug takes aim at heart and kidney disease in youth-onset diabetes

NCT ID NCT03899883

Disease control Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This pilot trial tests whether a single infusion of pegloticase, a drug that breaks down uric acid, can improve markers of heart and kidney health in young men aged 18–25 with youth-onset type 2 diabetes. High uric acid is common in this group and linked to later complications. The study measures blood pressure, artery stiffness, kidney blood flow, and other indicators one week after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a single infusion of pegloticase (Krystexxa), a drug that breaks down uric acid
What this could lead to
If it works, this could point toward a new way to protect the heart and kidneys in young people with type 2 diabetes.
What could go wrong
This is a very small pilot study with only 10 participants and a single dose, so results may not apply broadly. The drug can cause allergic reactions and is not yet tested in this age group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

11 people

The number who actually took part.

Started

Jan 2020

Finished

Apr 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 25 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men * Ages 18-25 * Youth-onset T2D (diagnosis \<21 years) * serum uric acid ≥ 5 mg/dl Exclusion Criteria: * Glucose-6-phosphate (G6P) deficiency * Allergies to seafood or iodine * MRI contraindications (severe claustrophobia, non-MRI compatible implantable devices, weight ≥ 450 lbs) * HbA1C ≥ 12% * Recent (1 month prior) diagnosis of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemia * Congestive heart failure * History of multiple and/or severe allergies or anaphylactic reactions * Uric acid lowering medications (ie: allopurinol, febuxostat) * Pegvisomant, pegvaliase, peginterferon alfa 2b, peginterferon alfa 2a, pegfilgrastim, pegaspargase, pegaptanib, pegademase and certolizumab pegol * Participation in another investigational study within 2 weeks prior to study

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Conditions

The condition(s) this trial relates to.

Diabetes Complications diabetes mellitus diabetic kidney disease Hyperuricemia type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes Diabetes complications Diabetes mellitus type 2 Diabetic kidney disease Diabetic nephropathies Hyperuricemia Type 2 diabetes mellitus TYPE2 diabetes

Contacts and locations

Locations

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

More trials for these conditions

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