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New treatment option for Diabetic Kidney Disease
Official title Uric Acid Lowering Trial in Youth Onset T2D
ClinicalTrials.gov ID: NCT03899883
What this study is testing
What is Pegloticase 8 MG/ML [Krystexxa]?
Pegloticase 8 MG/ML [Krystexxa] is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diabetic kidney disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 7 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 25, men only
You may be able to join if
- Ages 18-25
- Youth-onset T2D (diagnosis \<21 years)
- serum uric acid ≥ 5 mg/dl
You likely can't join if
- 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
See the full eligibility criteria
- Ages 18-25
- Youth-onset T2D (diagnosis \<21 years)
- serum uric acid ≥ 5 mg/dl
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 7 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.