Diabetic Kidney DiseasePhase 2ULTRA-T2DNCT03899883
Uric Acid Lowering Trial in Youth Onset T2D
A Phase 2 study testing Pegloticase 8 MG/ML [Krystexxa] in people with Diabetic Kidney Disease and Hyperuricemia, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Adolescents and young adults with youth-onset type 2 diabetes (T2D) are disproportionally impacted by hyperuricemia compared to non-diabetic peers and youth with type 1 diabetes (T1D). In fact, 50% of males with youth-onset T2D have serum uric acid (SUA) greater than 6.8 mg/dl. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men only
- Conditions the study is for
- Diabetic Kidney Disease, Hyperuricemia, Diabetes
- What is being tested?
- Pegloticase 8 MG/ML [Krystexxa]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 13 Apr 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Men
- Ages 18-25
- Youth-onset T2D (diagnosis <21 years)
- serum uric acid ≥ 5 mg/dl
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: ULTRA-T2D Study: Uric Acid Lowering Trial in Youth Onset T2D
Adolescents and young adults with youth-onset type 2 diabetes (T2D) are disproportionally impacted by hyperuricemia compared to non-diabetic peers and youth with type 1 diabetes (T1D). In fact, 50% of males with youth-onset T2D have serum uric acid (SUA) greater than 6.8 mg/dl. The investigators also recently demonstrated that higher SUA conferred greater odds of developing hypertension and diabetic kidney disease (DKD) in youth with T2D over 7 years follow-up. Elevated SUA is thought to lead to cardiovascular disease (CVD) and DKD by inflammation, mitochondrial dysfunction and deleterious effects on nephron mass. While there are studies demonstrating beneficial effects of uric acid (UA) lowering on vascular health in the general population, there are no studies in youth-onset T2D. Youth-onset T2D carries a greater risk of DKD and CVD compared to adult-onset T2D and T1D.
Accordingly, a clinical trial evaluating UA lowering therapies is needed in youth-onset T2D. Krystexxa (pegloticase), a uricase, effectively lowers SUA and therefore holds promise as a novel therapy to impede the development of CVD and DKD in youth-onset T2D. This proposal describes a pilot and feasibility trial evaluating the effect of UA lowering by pegloticase on markers of CVD and DKD in ten (n=10) youth aged 18-25 with youth-onset T2D (diagnosed <21 years of age) over 7 days. The overarching hypothesis is that pegloticase improves marker of cardiorenal health by lowering UA.
- Conditions
- Diabetic Kidney Disease, Hyperuricemia, Diabetes, Diabetes Mellitus, Type 2, Type2 Diabetes, Type 2 Diabetes Mellitus
- Being tested
- Pegloticase 8 MG/ML [Krystexxa]
- Medical subject headings
- Diabetic Nephropathies, Hyperuricemia, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegloticase 8 MG/ML [Krystexxa]Drug
One time dosing of pegloticase will be administered. Participants will receive an infusion of pegloticase over two hours in the outpatient clinical and translational research center (CTRC) at Children's Hospital Colorado, and will be monitored after infusion.
| Study group | Role | What they receive |
|---|---|---|
| Pegloticase | Experimental | Single administration of pegloticase (8 mg IV in 250 mL 0.9% normal saline) Receives: Drug: Pegloticase 8 MG/ML [Krystexxa] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Systolic blood pressure measured by sphygmomanometer
Measured: Baseline and 1 week post treatment
Diastolic Blood Pressure
Diastolic blood pressure measured by sphygmomanometer
Measured: Baseline and 1 week post treatment
Mean Arterial Pressure
Mean arterial pressure measured by sphygmomanometer
Measured: Baseline and 1 week post treatment
Pulse Wave Velocity (PWV)
Measured by Aortic MRI renal MRI (4D Flow)
Measured: Baseline and 1 week post treatment
Wall Shear Stress (WSS)
Measured by Aortic MRI renal MRI (4D Flow)
Measured: Baseline and 1 week post treatment
Renal Blood Flow
Measured by 4D Flow renal MRI
Measured: Baseline and 1 week post treatment
Glomerular Filtration Rate
Measured by Iohexol Clearance in Plasma
Measured: Baseline and 1 week post treatment
Urine Albumin-creatinine Ratio
Measured by albumin and creatinine concentrations in urine
Measured: Baseline and 1 week post treatment
Secondary outcomes (1)
Serum Uric Acid (sUA)
Measured by baseline sUA compared to sUA one week later
Measured: Baseline and 1 week post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Jan 2020
- Primary completion13 Apr 2023
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899883
- Sponsor's protocol ID
- 18-1700
- Acronym
- ULTRA-T2D
- Status last verified
- Jun 2026
- First submitted
- 28 Mar 2019
- Last updated
- 28 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ULTRA-T2D Study: Uric Acid Lowering Trial in Youth Onset T2D
- ClinicalTrials.gov ID
- NCT03899883
- Acronym / sponsor ID
- ULTRA-T2D / 18-1700
- Conditions
- Diabetic Kidney Disease, Hyperuricemia, Diabetes, Diabetes Mellitus, Type 2, Type2 Diabetes, Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 13 Apr 2023 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Posted 28 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adolescents and young adults with youth-onset type 2 diabetes (T2D) are disproportionally impacted by hyperuricemia compared to non-diabetic peers and youth with type 1 diabetes (T1D). In fact, 50% of males with youth-onset T2D have serum uric acid (SUA) greater than 6.8 mg/dl. The investigators also recently demonstrated that higher SUA conferred greater odds of developing hypertension and diabetic kidney disease (DKD) in youth with T2D over 7 years follow-up. Elevated SUA is thought to lead to cardiovascular disease (CVD) and DKD by inflammation, mitochondrial dysfunction and deleterious effects on nephron mass. While there are studies demonstrating beneficial effects of uric acid (UA) lowering on vascular health in the general population, there are no studies in youth-onset T2D. Youth-onset T2D carries a greater risk of DKD and CVD compared to adult-onset T2D and T1D.
Accordingly, a clinical trial evaluating UA lowering therapies is needed in youth-onset T2D. Krystexxa (pegloticase), a uricase, effectively lowers SUA and therefore holds promise as a novel therapy to impede the development of CVD and DKD in youth-onset T2D. This proposal describes a pilot and feasibility trial evaluating the effect of UA lowering by pegloticase on markers of CVD and DKD in ten (n=10) youth aged 18-25 with youth-onset T2D (diagnosed <21 years of age) over 7 days. The overarching hypothesis is that pegloticase improves marker of cardiorenal health by lowering UA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegloticase | Experimental | Drug: Pegloticase 8 MG/ML [Krystexxa]Single administration of pegloticase (8 mg IV in 250 mL 0.9% normal saline) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men
- Ages 18-25
- Youth-onset T2D (diagnosis <21 years)
- serum uric acid ≥ 5 mg/dl
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegloticase 8 MG/ML [Krystexxa]One time dosing of pegloticase will be administered. Participants will receive an infusion of pegloticase over two hours in the outpatient clinical and translational research center (CTRC) at Children's Hospital Colorado, and will be monitored after infusion. | Drug | Pegloticase |
Primary outcome
Systolic Blood Pressure
Time frame: Baseline and 1 week post treatment
Systolic blood pressure measured by sphygmomanometer
Diastolic Blood Pressure
Time frame: Baseline and 1 week post treatment
Diastolic blood pressure measured by sphygmomanometer
Mean Arterial Pressure
Time frame: Baseline and 1 week post treatment
Mean arterial pressure measured by sphygmomanometer
Pulse Wave Velocity (PWV)
Time frame: Baseline and 1 week post treatment
Measured by Aortic MRI renal MRI (4D Flow)
Wall Shear Stress (WSS)
Time frame: Baseline and 1 week post treatment
Measured by Aortic MRI renal MRI (4D Flow)
Renal Blood Flow
Time frame: Baseline and 1 week post treatment
Measured by 4D Flow renal MRI
Glomerular Filtration Rate
Time frame: Baseline and 1 week post treatment
Measured by Iohexol Clearance in Plasma
Urine Albumin-creatinine Ratio
Time frame: Baseline and 1 week post treatment
Measured by albumin and creatinine concentrations in urine
1 secondary outcome
Serum Uric Acid (sUA)
Time frame: Baseline and 1 week post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegloticase 8 MG/ML [Krystexxa] in people with Diabetic Kidney Disease and Hyperuricemia, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: Baseline and 1 week post treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.