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Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant

Kidney Transplant Clinical Trial

Official title:
A Multicenter, Open-Label, Efficacy and Safety Study of Pegloticase in Patients With Uncontrolled Gout Who Have Undergone Kidney Transplantation

Clinical Trial Summary

The primary objective of this study is to evaluate the effect of pegloticase on the response rate of sustained serum uric acid (sUA) reduction to sUA < 6 mg/dL during Month 6 of treatment.

Clinical Trial Description

The study design includes: 1) a Screening Period, lasting up to 35 days; 2) a 24-week treatment period which includes an End-of-Study (Week 24) /Early Termination Visit; 3) a safety follow-up phone/email Visit 30 days after the last infusion; and 4) a 3 month post-treatment follow up visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04087720
Study type Interventional
Source Horizon Pharma Ireland, Ltd., Dublin Ireland
Contact
Status Completed
Phase Phase 4
Start date September 9, 2019
Completion date September 7, 2021
View Details
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