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

Completed · Phase 1

Conditions studied: Chronic Kidney Disease Stage 5

In brief

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.

Key facts

Study ID

NCT01739660

Run by

Savient Pharmaceuticals

People needed

12

Starts

2012-12-01

Expected to finish

2013-04-01

Last updated by the study team

2013-10-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Uncontrolled congestive heart failure
• Refractory chronic gout
• History of drug and/or alcohol abuse within 6 months prior to screening
• History of or current clinically significant mental disorder or an antagonistic personality that compromises the validity of the informed consent
• Donation of blood or plasma within 30 days prior to dosing
• History of or current hepatitis, or carriers of hepatitis B surface antigen (HbsAg) and/or hepatitis C antibodies (anti-HC).
• Use of an investigational drug or product, within 30 days
• History of clinically significant drug allergies or sensitivities
• Females with a positive pregnancy test or who are breast feeding at Screening or plan to breast feed within 30 days of dosing
• A baseline QTc interval ≥ 490 milliseconds for males and ≥ 510 milliseconds for females
• Is unable to refrain from alcohol
• 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
• 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
• Has poorly controlled malignant hypertension (systolic blood pressure [SBP] > 200 mm Hg and/or diastolic blood pressure [DBP] > 120 mm Hg,
• Concurrent use of urate-lowering drugs

Where it is running

• Davita Clinical Research — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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