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CLINICAL TRIALS PROFILE FOR PEGLOTICASE
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All Clinical Trials for pegloticase
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00675103 | Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients | Completed | Savient Pharmaceuticals | Phase 3 | 2008-05-01 | The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24 week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase i.v. was at least one year before study entry. This study is limited to four study centers in the US. |
| 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. |
| NCT03303989 | REduCing Immunogenicity to PegloticasE (RECIPE) Study | Not yet recruiting | University of Michigan | Phase 2 | 2017-12-31 | 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 myclophenolate moefitil 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 | Not yet recruiting | University of Alabama at Birmingham | Phase 2 | 2017-12-31 | 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 myclophenolate moefitil 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 | Not yet recruiting | University of Colorado Denver School of Medicine Barbara Davis Center | Phase 2 | 2019-06-01 | 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 | Recruiting | 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 | >Sponsor | >Phase | >Start Date | >Summary |
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