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

Chronic Kidney Disease Stage 5 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739660
• Other study ID #: M0403
• Secondary ID: 10122
• Status: Completed
• Phase: Phase 1
• First received: November 29, 2012
• Last updated: October 24, 2013
• Start date: December 2012
• Est. completion date: April 2013

Study information

• Verified date: October 2013
• Source: Savient Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 5
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Pegloticase
a single 8 mg iv (in the vein) dose before hemodialysis session

Locations

Country	Name	City	State
United States	Davita Clinical Research	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Savient Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• To evaluate the pharmacokinetics (PK) of pegloticase after a single-dose administration to hemodialysis patients when administered starting 3 hours before dialysis		1 month	No
Secondary	• To evaluate the pharmacodynamics (PD) of pegloticase and SUA, before and after hemodialysis sessions		1 month	No