Loading clinical trials...

Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

NCT04087720•Amgen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Willing and able to give informed consent;
•Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study;
•Adult men or women ≥ 18 years of age;
•Is a recipient of a de novo kidney from a living or deceased donor and is \>1 year post transplant prior to screening;
•Is on a stable standard of care immunosuppression therapy for at least 3 months prior to screening;
•Kidney allograft is functional at entry, based on an estimated glomerular filtration rate (eGFR) ≥ 15 mL/min/1.73m²;
•Women of childbearing potential have a negative screening serum pregnancy test and will be required to use a medically approved form of birth control during their participation in the study;
•Uncontrolled gout, defined as:
•1. 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
•2. Inability to maintain sUA \<6 mg/dL on other urate-lowering therapy or intolerable side effects or contraindicated with conventional urate-lowering therapy, and
+3 more criteria

Exclusion Criteria

•Any other organ transplant beside kidney;
•Any severe infection, unless treated and completely resolved at least 2 weeks prior to Day 1;
•Chronic or active hepatitis B virus infection;
•Known history of hepatitis C virus ribonucleic acid (RNA) positivity unless treated and viral load is negative;
•Known history of human immunodeficiency virus (HIV) positivity;
•Glucose-6-phosphate dehydrogenase (G6PD) deficiency (tested at the Screening Visit);
•Decompensated congestive heart failure or hospitalization for congestive heart failure within 3 months of the Screening Visit, uncontrolled arrhythmia, treatment for acute coronary syndrome (myocardial infarction or unstable angina), or uncontrolled blood pressure (\> 160/100 mm Hg) at the end of the Screening Period (Day 1 prior to infusion);
•Pregnant, planning to become pregnant, breastfeeding, planning to impregnate female partner, or not using an effective form of birth control, as determined by the Investigator;
•Prior treatment with pegloticase, another recombinant uricase (rasburicase), or concomitant therapy with a polyethylene glycol-conjugated drug;
•Known allergy to pegylated products or history of anaphylactic reaction to a recombinant protein or porcine product;
+9 more criteria

Locations (8)

University of Alabama Birmingham

Birmingham, Alabama, United States

Nephrology Consultants

Huntsville, Alabama, United States

Keck School of Medicine of USC

Los Angeles, California, United States

Amicis Research Center

Northridge, California, United States

Genesis Clinical Research

Tampa, Florida, United States

Coastal Medical Research

Brunswick, Georgia, United States

Duke University Medical Center

Durham, North Carolina, United States

Clear Lake Specialties

Webster, Texas, United States

Key Dates

Start Date

September 9, 2019

Primary Completion Date

July 6, 2021

Completion Date

September 7, 2021

Last Updated

June 26, 2024

Enrollment

ACTUAL participants

Conditions

Uncontrolled GoutKidney Transplant

Interventions

Pegloticase

BIOLOGICAL

Pilot Trial of Supplemental Vitamin A and Nicotinamide

NCT05702398

Skin CancerKidney Transplant Recipients

View study

RECRUITINGPHASE2

Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients

NCT07116746

GoutGouty Arthritis+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Pilot Trial of Supplemental Vitamin A and Nicotinamide

Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients

Parathyroidectomy After Kidney Transplantation

Treatment of Chronic Active Antibody Mediated Rejection With Tocilizumab

A Mixed Cohort, Multicentre Exploratory Study of Non-invasive Quantitative Assessment of Renal Graft Function With Non-contrast Functional Magnetic Resonance Imaging

The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient