A Phase 2 interventional study of Pegloticase 8 MG/ML [Krystexxa] in Diabetic Kidney Disease, Hyperuricemia and Diabetes, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to male participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Treatment
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Among 11 studies in Diabetic Nephropathies by University of Colorado, Denver — none open to participants now, 3 under way, none of them phase 3. Diabetic Nephropathies · University of Colorado, Denver.
Among the 11 studies in Diabetic Nephropathies by University of Colorado, Denver, this one is one of 2 that started in 2020, is one of 3 in phase 2, and was the 5th registered.
543 studies on the registry are indexed under Diabetic Nephropathies; 110 are open to participants now.
Browse Diabetic Nephropathies studies →None of the 11 studies in Diabetic Nephropathies by University of Colorado, Denver is open now. The open studies under Diabetic Nephropathies, anywhere →
Of the 50 Diabetic Nephropathies studies recruiting now, 23 (46%) set no upper age limit and 16 (32%) stop at 75 or younger; 5 take children under 18; 8 take healthy volunteers.
This study: 18 Years to 25 Years · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 5 · Phase 3 1 · Phase 4 1
First in 2017; this study’s year is marked. 2 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 11 is below the median of 78 across 388 interventional studies indexed under Diabetic Nephropathies.
Median enrollment 24 across the 7 interventional studies, 58 across the 4 observational. Of the 8 that completed or were terminated, 6 (75%) have results posted.
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University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
2 of the studies in Diabetic Nephropathies by University of Colorado, Denver that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05507892University of Colorado, DenverRenal Mechanism of SGLT2 Inhibition | 2026-12-15 |
| NCT05319990University of Colorado, DenverPathogenesis of Kidney Disease in Type 1 Diabetes: a Modern Kidney Biopsy Cohort (The PANDA Study) | 2027-06-30 |
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Among the 11 studies in Diabetic Nephropathies by University of Colorado, Denver, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single administration of pegloticase (8 mg IV in 250 mL 0.9% normal saline)
Drug: Pegloticase 8 MG/ML [Krystexxa]
Drug page: Pegloticase
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.
Systolic Blood Pressure
Systolic blood pressure measured by sphygmomanometer
Time frame: Baseline and 1 week post treatment
Diastolic Blood Pressure
Diastolic blood pressure measured by sphygmomanometer
Time frame: Baseline and 1 week post treatment
Mean Arterial Pressure
Mean arterial pressure measured by sphygmomanometer
Time frame: Baseline and 1 week post treatment
Pulse Wave Velocity (PWV)
Measured by Aortic MRI renal MRI (4D Flow)
Time frame: Baseline and 1 week post treatment
Wall Shear Stress (WSS)
Measured by Aortic MRI renal MRI (4D Flow)
Time frame: Baseline and 1 week post treatment
Renal Blood Flow
Measured by 4D Flow renal MRI
Time frame: Baseline and 1 week post treatment
Glomerular Filtration Rate
Measured by Iohexol Clearance in Plasma
Time frame: Baseline and 1 week post treatment
Urine Albumin-creatinine Ratio
Measured by albumin and creatinine concentrations in urine
Time frame: Baseline and 1 week post treatment
Serum Uric Acid (sUA)
Measured by baseline sUA compared to sUA one week later
Time frame: Baseline and 1 week post treatment
Recruitment over 2-year study period (study start through completion of N=10 enrollment), targeting up to 14 men aged 18-35 with youth-onset T2D (diagnosis ≤ 25 yrs) and SUA ≥5 mg/dL. Participants are recruited from three clinical sites at the University of Colorado Anschutz Medical Campus: the Barbara Davis Center for Childhood Diabetes, the adult diabetes clinic at University of Colorado Hospital, and the pediatric T2D clinic at Children's Hospital Colorado.
| Milestone | Men With Youth-onset T2D |
|---|---|
| Started | 11 |
| Completed | 9 |
| Not completed | 2 |
Systolic blood pressure measured by sphygmomanometer
| mmHg | Men With Youth-onset T2D |
|---|---|
| Baseline | 80 ± 12 |
| 1 week post treatment | 85 ± 11 |
Diastolic blood pressure measured by sphygmomanometer
| mmHg | Men With Youth-onset T2D |
|---|---|
| Baseline | 135 ± 13 |
| 1 week post treatment | 132 ± 9 |
Mean arterial pressure measured by sphygmomanometer
| mmHg | Men With Youth-onset T2D |
|---|---|
| Baseline | 98 ± 10 |
| 1 week post treatment | 101 ± 10 |
Measured by Aortic MRI renal MRI (4D Flow)
| m/s | Men With Youth-onset T2D |
|---|---|
| Baseline | 4.8 ± 1.3 |
| 1 week post surgery | 4.3 ± 0.8 |
Measured by Aortic MRI renal MRI (4D Flow)
| Pa | Men With Youth-onset T2D |
|---|---|
| Baseline | 1.2 ± 0.16 |
| 1 week post treatment | 1.1 ± 0.10 |
Measured by baseline sUA compared to sUA one week later
| mg/dL | Men With Youth-onset T2D |
|---|---|
| Baseline | 6.4 (6.0 to 7.3) |
| 1 week post treatment | 0.5 (0.5 to 4.6) |
Measured by 4D Flow renal MRI
| mL/cycle | Men With Youth-onset T2D |
|---|---|
| Baseline | 18.4 ± 5.0 |
| 1 week post treatment | 18.2 ± 5.3 |
Measured by Iohexol Clearance in Plasma
| mL/min/1.73m^2 | Men With Youth-onset T2D |
|---|---|
| Baseline | 113 ± 20 |
| 1 week post treatment | 122 ± 19 |
Measured by albumin and creatinine concentrations in urine
| mg/g | Men With Youth-onset T2D |
|---|---|
| Baseline | 18 (9 to 578) |
| 1 week post treatment | 21 (6 to 211) |
Collected over Baseline to 1 week post treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Men With Youth-onset T2D | 0/11 (0%) | 0/11 (0%) | 5/11 (45.5%) |
| Event | Men With Youth-onset T2D |
|---|---|
| Pegloticase Infusion ReactionGeneral disorders | 2/11 |
| Back and neck painGeneral disorders | 1/11 |
| Post-infusion hyperglycemia requiring insulin administrationMetabolism and nutrition disorders | 1/11 |
| Superficial blood clot after IV placementInjury, poisoning and procedural complications | 1/11 |
| GI discomfortGastrointestinal disorders | 1/11 |
| WeaknessGeneral disorders | 1/11 |
| Age, Continuous(Years) | Men With Youth-onset T2D |
|---|---|
| Mean | 22 ± 5 |
| Sex: Female, Male(Participants) | Men With Youth-onset T2D |
|---|---|
| Female | 0 |
| Male | 11 |
| Race (NIH/OMB)(Participants) | Men With Youth-onset T2D |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Ethnicity (NIH/OMB)(Participants) | Men With Youth-onset T2D |
|---|---|
| Hispanic or Latino | 8 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Mean arterial pressure(mmHg) | Men With Youth-onset T2D |
|---|---|
| Mean | 98 ± 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Jan 2020 to primary completion in Apr 2023, 39 months.
Results were first posted in Jul 2026, 3 years 3 months after primary completion.
Of 52 phase 2 interventional studies under Diabetic Nephropathies, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 31. This study's 39 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pegloticase
University of Colorado, Denver →