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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 75
Updated:10/19/2013
Start Date:December 2012
End Date:September 2013
Contact:Jennifer Bookey, CCRC
Email:jennifer.bookey@davita.com
Phone:612-852-7010

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A Phase 1, Single Site, Open-Label Study to Assess the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis


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.


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.

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
We found this trial at
1
site
825 South 8th Street
Minneapolis, Minnesota 55404
888-345-2567
?
mi
from
Minneapolis, MN
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