clinical trial · NCT04087720
Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant
Amgen·phase4·completed·n = 20
Uncontrolled GoutKidney TransplantPegloticase
brief 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.
started
Sep 9, 2019
primary completion
Jul 6, 2021
completion
Sep 7, 2021
last updated
Jun 26, 2024
detailed 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 acquired from Horizon in 2024.
official title
A Multicenter, Open-Label, Efficacy and Safety Study of Pegloticase in Patients With Uncontrolled Gout Who Have Undergone Kidney Transplantation
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol