Uric Acid Lowering Trial in Youth Onset T2D (ULTRA-T2D)
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ClinicalTrials.gov Identifier: NCT03899883 |
Recruitment Status :
Recruiting
First Posted : April 2, 2019
Last Update Posted : February 17, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
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Diabetic Kidney Disease Hyperuricemia Diabetes Diabetes Mellitus, Type 2 Type2 Diabetes Type 2 Diabetes Mellitus Diabetic Nephropathies Diabetes Complications | Drug: Pegloticase 8 MG/ML [Krystexxa] | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | ULTRA-T2D Study: Uric Acid Lowering Trial in Youth Onset T2D |
Actual Study Start Date : | January 1, 2020 |
Estimated Primary Completion Date : | May 31, 2023 |
Estimated Study Completion Date : | May 31, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Pegloticase
Single administration of pegloticase (8 mg IV in 250 mL 0.9% normal saline)
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Drug: 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. |
- Cardiovascular Markers [ Time Frame: 5 min ]Measured by Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP)
- Pulse Wave Velocity (PWV) [ Time Frame: 2 hours (x2 study visits) ]Measured by Aortic MRI renal MRI (4D Flow)
- Wall Shear Stress (WSS) [ Time Frame: 2 hours (x2 study visits) ]Measured by Aortic MRI renal MRI (4D Flow)
- Renal Blood Flow [ Time Frame: 1 hour (x2 study visits) ]Measured by 4D Flow renal MRI
- Glomerular Filtration Rate [ Time Frame: 4 hours (x2 study visits) ]Measured by Iohexol Clearance in Plasma
- Albumin Excretion Rate (AER) [ Time Frame: 4 hours (x2 study visits) ]Measured by albumin and creatinine concentrations in urine
- Calculated parameters of intrarenal hemodynamic function [ Time Frame: 1 hour ]Measured by using existing renal hemodynamic calculations
- Change in serum uric acid (sUA) [ Time Frame: 1 hour ]Measured by baseline sUA compared to sUA one week later

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Ages Eligible for Study: | 18 Years to 25 Years (Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899883
Contact: Amy Rydin, MD | 720-777-2560 | amy.rydin@childrenscolorado.org | |
Contact: Carissa Vinovskis, MS | 720-777-2660 | carissa.vinovskis@childrenscolorado.org |
United States, Colorado | |
Children's Hospital Colorado | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Amy Rydin, MD 720-777-2560 amy.rydin@childrenscolorado.org | |
Contact: Carissa Vinovskis, MS 720-777-2660 carissa.vinovskis@childrenscolorado.org | |
Principal Investigator: Amy Rydin, MD |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT03899883 |
Other Study ID Numbers: |
18-1700 |
First Posted: | April 2, 2019 Key Record Dates |
Last Update Posted: | February 17, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Kidney Diseases Diabetic Nephropathies Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Complications Hyperuricemia |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Urologic Diseases Pathologic Processes |