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NCT04087720 · ClinicalTrials.gov registry record · Phase 4
Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant
A Phase 4 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT04087720: Completed Phase 4 study, sponsored by Amgen.
NCT04087720 is a Phase 4 study that has completed, run by Amgen. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04087720, a Phase 4 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
sUA \< 6 mg/dL responders are defined as participants achieving and maintaining sUA \< 6 mg/dL for at least 80% of the time during Month 6, which includes pre-infusion and post-infusion results at Week 20, results at Week 21, pre-infusion and post-infusion results at Week 22, results at Week 23, results at Week 24, and unscheduled assessments of sUA collected between Week 20 and Week 24. Two-sided Exact Clopper-Pearson confidence interval is used for the calculation of the 95% confidence interva
Interventions
- BIOLOGICAL Pegloticase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-09-09 |
| Est. Completion | 2021-09-07 |
| Phase | Phase 4 |
What the finished NCT04087720 record still lists
NCT04087720 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Pegloticase is the first listed.
NCT04087720 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04087720 about?
NCT04087720 is a clinical study titled "Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant". 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.
What is the current status of trial NCT04087720?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2019-09-09. Estimated completion is 2021-09-07.
What interventions are being tested in trial NCT04087720?
The interventions under investigation include: Pegloticase (BIOLOGICAL).
Who is sponsoring clinical trial NCT04087720?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04087720's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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