| Trial ID: | L6430 |
| Source ID: | NCT03899883
|
| Associated Drug: |
Pegloticase 8 Mg/Ml [Krystexxa]
|
| Title: |
Uric Acid Lowering Trial in Youth Onset T2D
|
| Acronym: |
ULTRA-T2D
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetic Kidney Disease|Hyperuricemia|Diabetes|Diabetes Mellitus, Type 2|Type2 Diabetes|Type 2 Diabetes Mellitus|Diabetic Nephropathies|Diabetes Complications
|
| Interventions: |
DRUG: Pegloticase 8 MG/ML [Krystexxa]
|
| Outcome Measures: |
Primary: Cardiovascular Markers, Measured by Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP), 5 min|Pulse Wave Velocity (PWV), Measured by Aortic MRI renal MRI (4D Flow), 2 hours (x2 study visits)|Wall Shear Stress (WSS), Measured by Aortic MRI renal MRI (4D Flow), 2 hours (x2 study visits)|Renal Blood Flow, Measured by 4D Flow renal MRI, 1 hour (x2 study visits)|Glomerular Filtration Rate, Measured by Iohexol Clearance in Plasma, 4 hours (x2 study visits)|Albumin Excretion Rate (AER), Measured by albumin and creatinine concentrations in urine, 4 hours (x2 study visits) | Secondary: Calculated parameters of intrarenal hemodynamic function, Measured by using existing renal hemodynamic calculations, 1 hour|Change in serum uric acid (sUA), Measured by baseline sUA compared to sUA one week later, 1 hour
|
| Sponsor/Collaborators: |
Sponsor: University of Colorado, Denver
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
10
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2020-01-01
|
| Completion Date: |
2023-06-30
|
| Results First Posted: |
|
| Last Update Posted: |
2023-02-09
|
| Locations: |
Children's Hospital Colorado, Aurora, Colorado, 80045, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03899883
|
