➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
McKinsey
Express Scripts
Mallinckrodt
Harvard Business School

Last Updated: April 12, 2021

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR PEGLOTICASE

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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 >Phase >Start Date >Summary

Clinical Trial Conditions for pegloticase

Condition Name

Condition Name for pegloticase
Intervention Trials
Diabetes Mellitus, Type 2 1
Malignant Solid Neoplasm 1
Diabetes Complications 1
Hyperuricemia 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for pegloticase
Intervention Trials
Kidney Diseases 2
Gout 2
Hyperuricemia 1
Diabetic Nephropathies 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for pegloticase

Trials by Country

Trials by Country for pegloticase
Location Trials
United States 11
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for pegloticase
Location Trials
Alabama 2
North Carolina 2
Minnesota 1
Oregon 1
Maryland 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for pegloticase

Clinical Trial Phase

Clinical Trial Phase for pegloticase
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 3
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for pegloticase
Clinical Trial Phase Trials
Not yet recruiting 3
Completed 2
Recruiting 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for pegloticase

Sponsor Name

Sponsor Name for pegloticase
Sponsor Trials
Savient Pharmaceuticals 2
University of Michigan 1
M.D. Anderson Cancer Center 1
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for pegloticase
Sponsor Trials
Other 4
Industry 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Harvard Business School
Merck
Baxter
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.