Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis

Status Completed

Clinical Trial Summary

This is a Phase 1 single dose study conducted to evaluate the PK and PD of pegloticase administered to hemodialysis patients.

A single dose of pegloticase will be administered intravenously to male or female hemodialysis patients (N = 12) starting 3 hour prior to dialysis.

The study consists of a Screening Period, a Treatment Period, and Follow up Period.

Clinical Trial Description

End stage renal disease (ESRD) patients that require hemodialysis typically undergo hemodialysis treatment 3 times per week. As such, medications can be dialyzed off, reducing their clinical effectiveness; this study is being conducted to understand how dialysis affects the pharmacokinetics (PK) and pharmacodynamics (PD) of pegloticase. ;

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01739660
Study type	Interventional
Source	Savient Pharmaceuticals
Contact
Status	Completed
Phase	Phase 1
Start date	December 2012
Completion date	April 2013

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03539861` - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients	N/A
Recruiting	`NCT03311321` - Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients	N/A
Completed	`NCT05630729` - Living With CKD: An E-Learning Platform for Adolescents With CKD About the Disease and Its Management	N/A
Withdrawn	`NCT03998917` - Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis.
Recruiting	`NCT05489120` - Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)	N/A
Completed	`NCT04207203` - Healthy Diet Rich in Potassium to Chronic Kidney Disease With Sodium Zirconium Cyclosilicate: A Feasibility Study	N/A
Recruiting	`NCT01591876` - Exercise and Vascular Function in Haemodialysis Patients	Phase 2
Not yet recruiting	`NCT04608422` - Bioeletric Stimulation in Patients With Chronic Kidney Failure	N/A
Completed	`NCT03868371` - Acute Changes in the Mineral Metabolism After a High Phosphorous Containing Meal in Dialysis Patients	N/A
Active, not recruiting	`NCT05225454` - The Life Style Patterns and the Development Trend of Chronic Diseases in Healthy and Sub-healthy Groups Were Analyzed by Using Data-mining Techniques
Completed	`NCT03459807` - Blood Pressure Lowering in Dialysis (BOLD) Trial	Phase 2
Not yet recruiting	`NCT03005847` - The Effect of Fermented Papaya Preparation on Patients With Chronic Kidney Disease Under Dialysis Receiving Intravenous Iron	N/A
Recruiting	`NCT05726526` - CKD Specific Telemonitoring Platform to Minimize Adverse Outcomes in High Risk CKD Patients	N/A
Recruiting	`NCT04330807` - Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease	N/A
Active, not recruiting	`NCT02858778` - Timing of Acute Palliative Care Consultation in Critically Ill Patients	N/A
Active, not recruiting	`NCT04034966` - Utility of Telemedicine in the Follow-Up of Patients in Peritoneal Dialysis	N/A
Completed	`NCT04012957` - Desidustat in the Treatment of Anemia in CKD	Phase 3
Terminated	`NCT02039167` - Left Atrial Appendage Occlusion vs. Usual Care in Patients With Atrial Fibrillation and Severe Chronic Kidney Disease	N/A
Completed	`NCT01764854` - Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis	Phase 2
Active, not recruiting	`NCT06037265` - PR-0164 First in Human Clinical Trial of the PAVmed PortIO Intraosseous Infusion System	N/A