NCT04087720

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Uncontrolled Gout
• Kidney Transplant

Interventions

Type	Name	Description
BIOLOGICAL	Pegloticase	intravenous (IV) infusion

Timeline

• Start date: 2019-09-09
• Primary completion: 2021-07-06
• Completion: 2021-09-07
• First posted: 2019-09-12
• Last updated: 2024-06-26
• Results posted: 2022-07-26

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study