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

NCT01739660 | Completed Phase 1

• 2 other identifiers: M040310122
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease Stage 5

Keywords

Chronic Kidney Disease Stage 5; Hemodialysis; pegloticase

Outcome Measures

Primary Outcomes (1)

• • To evaluate the pharmacokinetics (PK) of pegloticase after a single-dose administration to hemodialysis patients when administered starting 3 hours before dialysis

  1 month

Secondary Outcomes (1)

• • To evaluate the pharmacodynamics (PD) of pegloticase and SUA, before and after hemodialysis sessions

  1 month

Study Arms (1)

Pegloticase

EXPERIMENTAL

Pegloticase 8 mg single intraveneous dose

Drug: Pegloticase

Interventions

Pegloticase DRUG

a single 8 mg iv (in the vein) dose before hemodialysis session

Also known as: KRYSTEXXA

Pegloticase

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Savient Pharmaceuticals: lead

Study Sites (1)

Davita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Pegloticase

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Harry Alcorn, Pharm D

  Davita Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 3, 2012
• Study Start: December 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 25, 2013

Record last verified: 2013-10

Locations

US (1)