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Last Updated: September 28, 2022

CLINICAL TRIALS PROFILE FOR KRYSTEXXA


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All Clinical Trials for KRYSTEXXA

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01739660 ↗ Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis Completed Savient Pharmaceuticals Phase 1 2012-12-01 This is a Phase 1 single dose study conducted to evaluate the PK and PD of pegloticase administered to hemodialysis patients. A single dose of pegloticase will be administered intravenously to male or female hemodialysis patients (N = 12) starting 3 hour prior to dialysis. The study consists of a Screening Period, a Treatment Period, and Follow up Period.
NCT02598596 ↗ Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect Completed IND 2 Results LLC Phase 2 2015-12-01 The purpose of this study is to evaluate the effect of a high zone tolerizing regimen of pegloticase on clinical outcome, as defined by an serum uric acid level <6 mg/dL, in patients with chronic, refractory gout.
NCT02598596 ↗ Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect Completed Ampel BioSolutions, LLC Phase 2 2015-12-01 The purpose of this study is to evaluate the effect of a high zone tolerizing regimen of pegloticase on clinical outcome, as defined by an serum uric acid level <6 mg/dL, in patients with chronic, refractory gout.
NCT03303989 ↗ REduCing Immunogenicity to PegloticasE (RECIPE) Study Completed University of Michigan Phase 2 2018-06-14 Pegloticase treatment for chronic refractory gout is limited by immunogenicity. The investigators propose the REduCing Immunogenicity to PegloticasE (RECIPE) trial to begin to investigate the question of whether a short course of immune modulating therapy with mycophenolate mofetil can significantly and safely attenuate immunogenicity to pegloticase and ensure patients afflicted with chronic refractory gout have better treatment outcomes and improved quality of life.
NCT03303989 ↗ REduCing Immunogenicity to PegloticasE (RECIPE) Study Completed University of Alabama at Birmingham Phase 2 2018-06-14 Pegloticase treatment for chronic refractory gout is limited by immunogenicity. The investigators propose the REduCing Immunogenicity to PegloticasE (RECIPE) trial to begin to investigate the question of whether a short course of immune modulating therapy with mycophenolate mofetil can significantly and safely attenuate immunogenicity to pegloticase and ensure patients afflicted with chronic refractory gout have better treatment outcomes and improved quality of life.
NCT03899883 ↗ Uric Acid Lowering Trial in Youth Onset T2D Recruiting University of Colorado Denver School of Medicine Barbara Davis Center Phase 2 2020-01-01 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.
NCT03905512 ↗ A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy Completed Selecta Biosciences, Inc. Phase 2 2019-03-28 This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Patients will be randomized 1:1 to receive treatment with SEL-212 or KRYSTEXXA® for 6 months. Efficacy assessments, as measured by serum uric acid (SUA) levels, will be conducted at intervals that are appropriate to determine treatment effect differences. Safety will be monitored throughout the study.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for KRYSTEXXA

Condition Name

Condition Name for KRYSTEXXA
Intervention Trials
Gout 2
Chronic Kidney Disease Stage 5 1
Tumor Lysis Syndrome 1
Diabetes 1
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Condition MeSH

Condition MeSH for KRYSTEXXA
Intervention Trials
Gout 2
Kidney Diseases 2
Tumor Lysis Syndrome 1
Diabetes Mellitus 1
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Clinical Trial Locations for KRYSTEXXA

Trials by Country

Trials by Country for KRYSTEXXA
Location Trials
United States 50
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Trials by US State

Trials by US State for KRYSTEXXA
Location Trials
Alabama 4
Pennsylvania 3
Ohio 3
Maryland 3
Texas 3
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Clinical Trial Progress for KRYSTEXXA

Clinical Trial Phase

Clinical Trial Phase for KRYSTEXXA
Clinical Trial Phase Trials
Phase 4 2
Phase 2 4
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for KRYSTEXXA
Clinical Trial Phase Trials
Completed 5
Not yet recruiting 1
Recruiting 1
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Clinical Trial Sponsors for KRYSTEXXA

Sponsor Name

Sponsor Name for KRYSTEXXA
Sponsor Trials
University of Michigan 1
University of Alabama at Birmingham 1
University of Colorado Denver School of Medicine Barbara Davis Center 1
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Sponsor Type

Sponsor Type for KRYSTEXXA
Sponsor Trials
Industry 5
Other 4
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