Chronic Kidney Disease Stage 5Phase 1NCT01739660
Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis
A Phase 1 study testing Pegloticase in people with Chronic Kidney Disease Stage 5, run by Savient Pharmaceuticals at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease Stage 5
- What is being tested?
- Pegloticase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Davita Clinical Research
Minneapolis, Minnesota, 55404
About this study
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
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.
Read the 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.
- Conditions
- Chronic Kidney Disease Stage 5
- Being tested
- Pegloticase
- Keywords
- Chronic Kidney Disease Stage 5, Hemodialysis, pegloticase
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegloticaseDrug
Also called KRYSTEXXA
a single 8 mg iv (in the vein) dose before hemodialysis session
| Study group | Role | What they receive |
|---|---|---|
| Pegloticase | Experimental | Pegloticase 8 mg single intraveneous dose Receives: Drug: Pegloticase |
What is being measured
The primary outcome is the main question the study is designed to answer.
• To evaluate the pharmacokinetics (PK) of pegloticase after a single-dose administration to hemodialysis patients when administered starting 3 hours before dialysis
Measured: 1 month
Secondary outcomes (1)
• To evaluate the pharmacodynamics (PD) of pegloticase and SUA, before and after hemodialysis sessions
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 5Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Savient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harry Alcorn, Pharm D, Principal investigator, Davita Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739660
- Sponsor's protocol ID
- M0403
- Other IDs
- 10122
- Status last verified
- Oct 2013
- First submitted
- 29 Nov 2012
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01739660
- Acronym / sponsor ID
- M0403
- Conditions
- Chronic Kidney Disease Stage 5
- Keywords
- Chronic Kidney Disease Stage 5, Hemodialysis, pegloticase
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Savient PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegloticase | Experimental | Drug: PegloticasePegloticase 8 mg single intraveneous dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PegloticaseAlso: KRYSTEXXAa single 8 mg iv (in the vein) dose before hemodialysis session | Drug | Pegloticase |
Primary outcome
• 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
1 secondary outcome
• To evaluate the pharmacodynamics (PD) of pegloticase and SUA, before and after hemodialysis sessions
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Alcorn, Pharm D principal investigator
Davita Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pegloticase in people with Chronic Kidney Disease Stage 5, run by Savient Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2013.