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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01739660
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : October 25, 2013
Information provided by (Responsible Party):
Savient Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Stage 5 Drug: Pegloticase Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Single Site, Open-Label Study to Assess the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis
Study Start Date : December 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Pegloticase

Arm Intervention/treatment
Experimental: Pegloticase
Pegloticase 8 mg single intraveneous dose
Drug: Pegloticase
a single 8 mg iv (in the vein) dose before hemodialysis session

Primary Outcome Measures :
  1. • To evaluate the pharmacokinetics (PK) of pegloticase after a single-dose administration to hemodialysis patients when administered starting 3 hours before dialysis [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. • To evaluate the pharmacodynamics (PD) of pegloticase and SUA, before and after hemodialysis sessions [ Time Frame: 1 month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01739660

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United States, Minnesota
Davita Clinical Research
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Savient Pharmaceuticals
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Principal Investigator: Harry Alcorn, Pharm D Davita Clinical Research

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Responsible Party: Savient Pharmaceuticals Identifier: NCT01739660    
Other Study ID Numbers: M0403
10122 ( Other Identifier: IND number )
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013
Keywords provided by Savient Pharmaceuticals:
Chronic Kidney Disease Stage 5
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency