Renal ImpairmentPhase 1NCT00733265
Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers
A Phase 1 study testing AZD6140 in people with Renal Impairment, run by AstraZeneca at 4 sites in United States.
Trial summary
The main purpose of this study is to examine how AZD6140 affects patients with severe kidney disease compared to volunteers with normal kidneys. Subjects in the study will receive one dose of AZD6140. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- AZD6140
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2007to Sep 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must have severe kidney disease
- Subjects who are matched to the kidney disease patients in terms of weight, age, and sex must have normal kidneys
- All women must be post-menopausal (no longer menstruating) or surgically sterile
Who cannot join
- Patients requiring dialysis
- History of allergy to aspirin or clopidogrel
- Have increased bleeding risk (for instance uncontrolled high blood pressure or a recent major injury)
- Recent history of fainting or light-headedness
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Research Site
Anaheim, California
Research Site
Miami, Florida
Research Site
Phoenix, Arizona
Research Site
San Antonio, Texas
About this study
The main purpose of this study is to examine how AZD6140 affects patients with severe kidney disease compared to volunteers with normal kidneys. Subjects in the study will receive one dose of AZD6140.
- Conditions
- Renal Impairment
- Being tested
- AZD6140
- Keywords
- Renal Impairment
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6140Drug
single oral dose
| Study group | Role | What they receive |
|---|---|---|
| AZD6140 | Experimental | Not described Receives: Drug: AZD6140 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of AZD6140 in patients with severe kidney disease compared to volunteers with normal kidneys
Measured: Scheduled times during the 3 days after the study drug is taken
Secondary outcomes (2)
Safety and tolerability of AZD6140 in patients with severe kidney disease compared to subjects with normal kidneys
Measured: Screening through completion of the study
Measure the effect of AZD6140 on how well blood clots in patients with severe kidney disease compared to subjects with normal kidneys
Measured: Scheduled times during the 3 days after the study drug is taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startFeb 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kathleen Butler, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733265
- Sponsor's protocol ID
- D5130C00015
- Other IDs
- AZD6140/Renal Study
- Status last verified
- Dec 2010
- First submitted
- 12 Aug 2008
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Butler K, Teng R. Pharmacokinetics, pharmacodynamics, and safety of ticagrelor in volunteers with severe renal impairment. J Clin Pharmacol. 2012 Sep;52(9):1388-98. doi: 10.1177/0091270011415526. Epub 2011 Sep 29.
PubMed 21960668
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00733265
- Acronym / sponsor ID
- D5130C00015
- Conditions
- Renal Impairment
- Keywords
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 13 Aug 2008 (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.
The main purpose of this study is to examine how AZD6140 affects patients with severe kidney disease compared to volunteers with normal kidneys. Subjects in the study will receive one dose of AZD6140.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD6140 | Experimental | Drug: AZD6140 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have severe kidney disease
- Subjects who are matched to the kidney disease patients in terms of weight, age, and sex must have normal kidneys
- All women must be post-menopausal (no longer menstruating) or surgically sterile
Key exclusion criteria (4 listed)
- Patients requiring dialysis
- History of allergy to aspirin or clopidogrel
- Have increased bleeding risk (for instance uncontrolled high blood pressure or a recent major injury)
- Recent history of fainting or light-headedness
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 |
|---|---|---|
| AZD6140single oral dose | Drug | AZD6140 |
Primary outcome
Blood levels of AZD6140 in patients with severe kidney disease compared to volunteers with normal kidneys
Time frame: Scheduled times during the 3 days after the study drug is taken
2 secondary outcomes
Safety and tolerability of AZD6140 in patients with severe kidney disease compared to subjects with normal kidneys
Time frame: Screening through completion of the study
Measure the effect of AZD6140 on how well blood clots in patients with severe kidney disease compared to subjects with normal kidneys
Time frame: Scheduled times during the 3 days after the study drug is taken
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 3 Dec 2010.
- Derived from this study: PubMed 21960668Butler K, Teng R. Pharmacokinetics, pharmacodynamics, and safety of ticagrelor in volunteers with severe renal impairment. J Clin Pharmacol. 2012 Sep;52(9):1388-98. doi: 10.1177/0091270011415526. Epub 2011 Sep 29.
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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.
Kathleen Butler, MD study director
AstraZeneca
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD6140 in people with Renal Impairment, run by AstraZeneca at 4 sites 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 3 inclusion and 4 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 3 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Blood levels of AZD6140 in patients with severe kidney disease compared to volunteers with normal kidneys (time frame: Scheduled times during the 3 days after the study drug is taken). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00733265, which also lists 1 linked publication.
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 3 Dec 2010.