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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Savient Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01739660
First received: November 29, 2012
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Chronic Kidney Disease Stage 5
Drug: Pegloticase
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Savient Pharmaceuticals:

Primary Outcome Measures:
  • • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • To evaluate the pharmacodynamics (PD) of pegloticase and SUA, before and after hemodialysis sessions [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: December 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pegloticase
Pegloticase 8 mg single intraveneous dose
Drug: Pegloticase
a single 8 mg iv (in the vein) dose before hemodialysis session
Other Name: KRYSTEXXA

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739660

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

No publications provided

Responsible Party: Savient Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01739660     History of Changes
Other Study ID Numbers: M0403, 10122
Study First Received: November 29, 2012
Last Updated: October 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Savient Pharmaceuticals:
Chronic Kidney Disease Stage 5
Hemodialysis
pegloticase

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 29, 2014