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Uric Acid Lowering Agent

Pegloticase 8 MG/ML [Krystexxa] for Type 2 Diabetes (ULTRA-T2D Trial)

Phase 2
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours (x2 study visits)
Awards & highlights

ULTRA-T2D Trial Summary

This trial is testing a medication to see if it can help improve marker of cardiorenal health by lowering uric acid levels in young adults with type 2 diabetes.

Eligible Conditions
  • Type 2 Diabetes
  • Diabetes
  • Diabetic Kidney Disease
  • High Uric Acid

ULTRA-T2D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours (x2 study visits)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours (x2 study visits) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Albumin Excretion Rate (AER)
Cardiovascular Markers
Glomerular Filtration Rate
+3 more
Secondary outcome measures
Calculated parameters of intrarenal hemodynamic function
Change in serum uric acid (sUA)

Side effects data

From 2021 Phase 2 trial • 35 Patients • NCT03303989
41%
Other (Lab abnormality, anxiety, neurological, and oral pain)
41%
Musculoskeletal (arthralgia, myalgia, low back pain, orthopedic trauma, bursitis tendonitis)
18%
Gastrointestinal
9%
Infections
9%
Cardia
9%
Skin
5%
Motor Vehicle Crash
5%
Chest Pain
5%
Abdominal Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pegloticase + Placebo
Pegloticase + MMF

ULTRA-T2D Trial Design

1Treatment groups
Experimental Treatment
Group I: PegloticaseExperimental Treatment1 Intervention
Single administration of pegloticase (8 mg IV in 250 mL 0.9% normal saline)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegloticase 8 MG/ML [Krystexxa]
2018
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,727 Previous Clinical Trials
2,141,670 Total Patients Enrolled
University of Colorado Denver School of Medicine Barbara Davis CenterLead Sponsor
16 Previous Clinical Trials
1,169 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still capacity for new participants in this medical experiment?

"Affirmative. Clinicaltrials.gov contains information that suggests this medical trial is in search of individuals to participate. It was initially posted on January 1st 2020 and modified most recently on February 1st 2022; 10 patients are needed from a single location for the duration of the study."

Answered by AI

How many participants are recruited for this research program?

"Indeed, per the information on clinicaltrials.gov, this research is actively searching for participants. This investigation was commenced on 1/1/2020 and has been modified most recently on 2/1/2022. The trial requires 10 people to be recruited across a single site."

Answered by AI

What previous experiments have analyzed the effects of Pegloticase 8 MG/ML [Krystexxa]?

"Currently, there are four operational clinical trials researching the effects of Pegloticase 8 MG/ML [Krystexxa] across 57 different locations. None are in Phase 3 and most occur in Aurora, Colorado."

Answered by AI

Do the entry criteria of this trial exclude persons aged 35 or above?

"As per the requirements set out in this study's eligibility criteria, only participants between 18 and 25 years of age can be considered for enrollment."

Answered by AI

Who is eligible to join this research project?

"This experiment seeks 10 volunteers, all between the ages of 18 and 25, who have been clinically diagnosed with hyperuricemia. To be eligible for inclusion in this study, participants must fulfill a set criteria: male gender identity; age range of 18 to 25 years old; diagnosis received before their 21st birthday; serum uric acid levels at or above 5 mg/dl."

Answered by AI

Has Krystexxa [Pegloticase 8 MG/ML] achieved regulatory authorization?

"Given the Phase 2 clinical trial status of Pegloticase 8 MG/ML [Krystexxa], our team at Power awarded it a safety rating of 2, as there is evidence to support its protection but not yet enough to prove efficacy."

Answered by AI
~2 spots leftby Mar 2025