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

NCT01739660 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-10-25

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Disease Stage 5

Interventions

DRUG

Pegloticase

a single 8 mg iv (in the vein) dose before hemodialysis session

Sponsors & Collaborators

  • Savient Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Harry Alcorn, Pharm D · Davita Clinical Research

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01739660 on ClinicalTrials.gov