CompletedPhase 4

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

United States20 participantsStarted 2019-09-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Hyperuricemia during screening as documented by sUA ≥ 7 mg/dL during Screening and prior to entry into the Treatment Period (Note: the sUA may be repeated up to 3 times during the Screening Period to confirm eligibility), and
✓. Inability to maintain sUA \<6 mg/dL on other urate-lowering therapy or intolerable side effects or contraindicated with conventional urate-lowering therapy, and
✓. At least 1 of the following:

What they're measuring

Percentage of Serum Uric Acid (sUA) < 6 mg/dL Responders During Month 6

Timeframe: Month 6 (Weeks 20, 21, 22, 23, 24)

Trial details

NCT IDNCT04087720

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-06

Results submitted2022-06-30

View on ClinicalTrials.gov More Uncontrolled Gout trials