Kidney DiseasesPhase 1NCT00119639
Study to Evaluate the Effect of Renal Function on the Single-Dose Pharmacokinetics of BAY 43-9006
A Phase 1 study testing Sorafenib (BAY43-9006, Nexavar) in people with Kidney Diseases, run by Bayer.
Trial summary
This is a 400 mg (2 x 200 mg tablets) sorafenib single dose, open-label study being conducted to compare the pharmacokinetics of plasma and urine and safety of sorafenib in subjects with severe, moderate, and mild renal impairment with those exhibiting normal renal function. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- Sorafenib (BAY43-9006, Nexavar)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Dec 2005
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post menopausal females
- Surgically sterile females
- Body Mass Index between 18-37
- Subjects with Clcr greater than 80 mL/min
- Subjects with Clcr 50 to 80 mL/min
- Subjects with Clcr 30 to 50 mL/min
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- Clcr less than 30 mL/min but not on dialysis
- Subjects must test negative for HIV
- Subjects must test negative for drugs of abuse at screening
Who cannot join
- All Subjects :
- Concomitant Medication: Treatment with CYP3A4 inducers, such as rifampin and St. John's Wort within 14 days of Day 1 until they leave the clinic on Day 7
- Donation of blood within 30 days of Day 1
- Recent participation in an investigational drug study during which active medication was given within 30 days of Day 1
- History of gastrointestinal disorder that could result in incomplete absorption of study drug
- Malignancy
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- Significant neurologic or psychiatric disorders
- History of drug or alcohol abuse in year prior to screening for this trial, or current intake or >14 standard alcoholic drinks per week
- Prior history of epilepsy or other seizure disorders
- Known hypersensitivity to inhibitors of raf kinase or VEGFR-2
- Females of child-bearing potential
- Smoking > 10 cigarettes/day or equivalent
- Excessive consumption (more than five 8-oz. cups/day) of coffee or caffeine
- Healthy Volunteer:
- Existing failure of a major organ system, or a medical disorder that would impair the subject's ability to complete the study (in the opinion of the investigator or the sponsor), eg history of blood coagulation disorders
- Hematocrit value < 34% in the control group at screening
- Renal Impairment Groups:
- Existing failure of a major organ system or a medical disorder (other than the target disease) which would impair the subject's ability to complete the study (in the opinion of the investigator or the sponsor)
- Concomitant Medication: Renal impairment subjects taking phosphate binders, ion exchange resins and/or iron supplements may take them with their meals, but must withhold them on the morning of Day 1 (dosing day) until after their 4 hour post-dose tests and procedures are performed.
- Myocardial infarction, coronary artery bypass graft or percutaneous transluminal coronary angiography within 6 months of Day 1; unstable angina; uncontrolled significant hypertension within 3 months of Day 1; cerebral vascular accident or transient ischemic attack within 12 months of Day 1
- Subjects with hypertension who have had a medication or dose change within one week of Day 1
- Subjects requiring dialysis
- Subjects with kidney transplants
- Liver transaminase (AST, ALT) greater than 5 times the ULN at screening; any active liver disease or unexplained or persistent elevations in liver function tests
- Hematocrit value < 24% in the renal impaired groups
About this study
Official title: A Study to Evaluate the Effect of Renal Function on the Single-Dose Pharmacokinetics of Sorafenib (BAY 43-9006, Nexavar).
This is a 400 mg (2 x 200 mg tablets) sorafenib single dose, open-label study being conducted to compare the pharmacokinetics of plasma and urine and safety of sorafenib in subjects with severe, moderate, and mild renal impairment with those exhibiting normal renal function.
- Conditions
- Kidney Diseases
- Being tested
- Sorafenib (BAY43-9006, Nexavar)
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib (BAY43-9006, Nexavar)Drug
All subjects were given a open-label, single dose of 400mg sorafenib
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Sorafenib (BAY43-9006, Nexavar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of sorafenib in plasma and urine; single-dose safety of sorafenib in patients with renal impairment
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startJun 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119639
- Sponsor's protocol ID
- 11804
- Status last verified
- Jan 2009
- First submitted
- 8 Jul 2005
- Last updated
- 16 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of Renal Function on the Single-Dose Pharmacokinetics of Sorafenib (BAY 43-9006, Nexavar).
- ClinicalTrials.gov ID
- NCT00119639
- Acronym / sponsor ID
- 11804
- Conditions
- Kidney Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Study completion
- Dec 2005 (actual)
- First posted
- 14 Jul 2005 (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 400 mg (2 x 200 mg tablets) sorafenib single dose, open-label study being conducted to compare the pharmacokinetics of plasma and urine and safety of sorafenib in subjects with severe, moderate, and mild renal impairment with those exhibiting normal renal function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Sorafenib (BAY43-9006, Nexavar) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Post menopausal females
- Surgically sterile females
- Body Mass Index between 18-37
- Subjects with Clcr greater than 80 mL/min
- Subjects with Clcr 50 to 80 mL/min
Key exclusion criteria (25 listed)
- Concomitant Medication: Treatment with CYP3A4 inducers, such as rifampin and St. John's Wort within 14 days of Day 1 until they leave the clinic on Day 7
- Donation of blood within 30 days of Day 1
- Recent participation in an investigational drug study during which active medication was given within 30 days of Day 1
- History of gastrointestinal disorder that could result in incomplete absorption of study drug
- Malignancy
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 |
|---|---|---|
| Sorafenib (BAY43-9006, Nexavar)All subjects were given a open-label, single dose of 400mg sorafenib | Drug | Arm 1 |
Primary outcome
Pharmacokinetics of sorafenib in plasma and urine; single-dose safety of sorafenib in patients with renal impairment
Time frame: 2 weeks
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 16 Jan 2009.
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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.
Bayer Study Director study director
Bayer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sorafenib (BAY43-9006, Nexavar) in people with Kidney Diseases, run by Bayer.
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 9 inclusion and 25 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 16 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Pharmacokinetics of sorafenib in plasma and urine; single-dose safety of sorafenib in patients with renal impairment (time frame: 2 weeks). 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 16 Jan 2009.