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

2019-09-15 03:11:21 | BioPortfolio

Summary

This is a Phase 4, multicenter study of pegloticase in adult participants with uncontrolled gout who have undergone kidney transplantation. Approximately twenty participants will be enrolled. Study duration will be approximately 40 weeks.

The purpose of this study is to assess the efficacy and safety of pegloticase in kidney transplant participants with uncontrolled gout refractory to conventional urate lowering therapy.

Description

This is a multicenter study of pegloticase in adult participants with uncontrolled gout who have undergone kidney transplantation.

The study design will include: 1) a Screening Period, lasting up to 28 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

Conditions

Uncontrolled Gout

Intervention

Pegloticase

Location

Amicis Research Center
Northridge
California
United States
91324

Status

Recruiting

Source

Horizon Pharma Rheumatology LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-15T03:11:21-0400

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Dissociation Between Clinical Benefit and Persistent Urate Lowering in Patients with Chronic Refractory Gout Treated with Pegloticase.

Assess clinical benefit in patients with chronic refractory gout who did not meet the protocol-defined criteria of responders to pegloticase.

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Medical and Biotech [MESH] Definitions

Agents that increase uric acid excretion by the kidney (URICOSURIC AGENTS), decrease uric acid production (antihyperuricemics), or alleviate the pain and inflammation of acute attacks of gout.

Uricosuric that acts by increasing uric acid clearance. It is used in the treatment of gout.

An anti-inflammatory agent used in the treatment of rheumatoid arthritis. It also has uricosuric properties and has been used to treat gout.

A thiazole derivative and inhibitor of XANTHINE OXIDASE that is used for the treatment of HYPERURICEMIA in patients with chronic GOUT.

Gout suppressants that act directly on the renal tubule to increase the excretion of uric acid, thus reducing its concentrations in plasma.

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