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

NCT ID: NCT01739660

Last Updated: 2013-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Kidney Disease Stage 5

Keywords

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Chronic Kidney Disease Stage 5 Hemodialysis pegloticase

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Pegloticase

Pegloticase 8 mg single intraveneous dose

Group Type EXPERIMENTAL

Pegloticase

Intervention Type DRUG

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

Interventions

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Pegloticase

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

Intervention Type DRUG

Other Intervention Names

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KRYSTEXXA

Eligibility Criteria

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Inclusion Criteria

1. 18 and 75 years of age, inclusive
2. Agrees to employ best possible methods to abstain from becoming pregnant or impregnating another.
3. Stage V chronic kidney patients with minimal or no residual renal function receiving hemodialysis and stable on hemodialysis (3x week)
4. BMI = 18.5 kg/m2 to \< 45 kg/m2

Exclusion Criteria

1. Any surgical or medical condition that may interfere with drug absorption, distribution, metabolism, or excretion, or any other condition that may place the subject at risk

1. Glucose-6-phosphate dehydrogenase (G6PD) deficiency
2. Uncontrolled congestive heart failure
3. Refractory chronic gout
2. History of drug and/or alcohol abuse within 6 months prior to screening
3. History of or current clinically significant mental disorder or an antagonistic personality that compromises the validity of the informed consent
4. Donation of blood or plasma within 30 days prior to dosing
5. History of or current hepatitis, or carriers of hepatitis B surface antigen (HbsAg) and/or hepatitis C antibodies (anti-HC).
6. Use of an investigational drug or product, within 30 days
7. History of clinically significant drug allergies or sensitivities
8. Females with a positive pregnancy test or who are breast feeding at Screening or plan to breast feed within 30 days of dosing
9. A baseline QTc interval ≥ 490 milliseconds for males and ≥ 510 milliseconds for females
10. Is unable to refrain from alcohol
11. Has taken any prescription or over the counter medication within 7 days prior to treatment day that, in the opinion of the Investigator, could be expected to confound the PK or metabolism of the study drug
12. Has taken the following herbal agents or nutraceuticals within 7 days prior to Screening: chapparal, comfrey, germander, gin bu huan, kava, pennyroyal, skullcap, St. John's Wort, or valerian
13. Has poorly controlled malignant hypertension (systolic blood pressure \[SBP\] \> 200 mm Hg and/or diastolic blood pressure \[DBP\] \> 120 mm Hg,
14. Concurrent use of urate-lowering drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Savient Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harry Alcorn, Pharm D

Role: PRINCIPAL_INVESTIGATOR

Davita Clinical Research

Locations

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Davita Clinical Research

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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10122

Identifier Type: OTHER

Identifier Source: secondary_id

M0403

Identifier Type: -

Identifier Source: org_study_id