Renal ImpairmentPhase 1NCT01120314
Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild, Moderate and Severe Renal Impairment
A Phase 1 study testing OTAMIXABAN (XRP0673) in people with Renal Impairment, run by Sanofi at 4 sites in United States.
Trial summary
Primary Objective: To study effect of mild, moderate and severe renal impairment on the pharmacokinetics of Otamixaban. Secondary Objective: To assess the pharmacodynamic effects of Otamixaban on subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- OTAMIXABAN (XRP0673)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2010to Jul 2011
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject with renal impairment:
- Mild, moderate or severe renal impairment defined as Creatinine Clearance (CrCl) from 50 to 80, 30 to 50 and < 30 mL/min respectively, based on the Cockcroft-Gault formula,
- Body weight between 50.0 kg and 115.0 kg inclusive if male, between 40.0 kg and 95.0 kg inclusive if female, Body Mass Index between 18.0 and 34.9 kg/m2 inclusive.
- Stable chronic renal impairment as defined by Cockcroft-Gault formula,
- Vital signs, cardiac function and laboratory parameters within the acceptable range.
- Or matched subject (by age, gender and body weight) with normal renal function (defined as CrCl >80 mL/min) and certified as healthy by physical examination, medical history and laboratory findings.
- If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.
Who cannot join
- Uncontrolled clinically relevant cardiovascular, pulmonary, gastro-intestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female) or infectious disease, or signs of acute illness.
- Active hepatitis, hepatic insufficiency.
- Acute renal failure, nephrotic syndrome.
- History of or current hematuria of urologic origin.
- Subject requiring dialysis during the study.
- History or presence of drug or alcohol abuse within two years before inclusion.
Show all 9Show fewer
- Smoking more than 15 cigarettes or equivalent per day.
- Any significant change in chronic treatment medication within 14-days before inclusion.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Investigational Site Number 840002
Knoxville, Tennessee, 37920
Investigational Site Number 840003
Miami Gardens, Florida, 33169
Investigational Site Number 840005
Orlando, Florida, 32806
Investigational Site Number 840004
Saint Paul, Minnesota, 55144
About this study
Official title: An Open-label Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban Given as a Single 80 μg/kg Bolus Plus 100 µg/kg/h Continuous Infusion for 24 Hours in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function
Primary Objective:
- To study effect of mild, moderate and severe renal impairment on the pharmacokinetics of Otamixaban.
Secondary Objective:
- To assess the pharmacodynamic effects of Otamixaban on subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.
Read the detailed description
The study period for one subject is broken down as follows:
- 2 to 28 days of screening,
- 1 day of treatment,
- 8 to 11 days of follow-up after start of infusion.
There are 5 days in the unit starting the day before the start of infusion.
- Conditions
- Renal Impairment
- Being tested
- OTAMIXABAN (XRP0673)
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTAMIXABAN (XRP0673)Drug
Form: solution for injection
Route: intravenous
| Study group | Role | What they receive |
|---|---|---|
| Severe renal impairment population | Experimental | Not described Receives: Drug: OTAMIXABAN (XRP0673) |
| Moderate renal impairment population | Experimental | Not described Receives: Drug: OTAMIXABAN (XRP0673) |
| Mild renal impairment population | Experimental | Not described Receives: Drug: OTAMIXABAN (XRP0673) |
| Healthy population | Experimental | Healthy matched subjects Receives: Drug: OTAMIXABAN (XRP0673) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of Otamixaban (Observed concentration at the end of the infusion (Ceoi) and Areas Under the plasma concentration Curve(AUClast and AUC))
Measured: 4 days
Secondary outcomes (1)
Pharmacodynamic effect based on coagulation parameters (activated Partial Prothrombin Time (aPTT), Prothrombin Time (PT) and International Normalized Ratio (INR))
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120314
- Sponsor's protocol ID
- POP6537
- Other IDs
- U1111-1116-5821
- Status last verified
- May 2014
- First submitted
- 6 May 2010
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban Given as a Single 80 μg/kg Bolus Plus 100 µg/kg/h Continuous Infusion for 24 Hours in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function
- ClinicalTrials.gov ID
- NCT01120314
- Acronym / sponsor ID
- POP6537
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 May 2010 (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.
Primary Objective:
- To study effect of mild, moderate and severe renal impairment on the pharmacokinetics of Otamixaban.
Secondary Objective:
- To assess the pharmacodynamic effects of Otamixaban on subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.
Detailed description
The study period for one subject is broken down as follows:
- 2 to 28 days of screening,
- 1 day of treatment,
- 8 to 11 days of follow-up after start of infusion.
There are 5 days in the unit starting the day before the start of infusion.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Severe renal impairment population | Experimental | Drug: OTAMIXABAN (XRP0673) |
| Moderate renal impairment population | Experimental | Drug: OTAMIXABAN (XRP0673) |
| Mild renal impairment population | Experimental | Drug: OTAMIXABAN (XRP0673) |
| Healthy population | Experimental | Drug: OTAMIXABAN (XRP0673)Healthy matched subjects |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject with renal impairment:
- Or matched subject (by age, gender and body weight) with normal renal function (defined as CrCl >80 mL/min) and certified as healthy by physical examination, medical history and laboratory findings.
- If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.
Key exclusion criteria (9 listed)
- Uncontrolled clinically relevant cardiovascular, pulmonary, gastro-intestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female) or infectious disease, or signs of acute illness.
- Active hepatitis, hepatic insufficiency.
- Acute renal failure, nephrotic syndrome.
- History of or current hematuria of urologic origin.
- Subject requiring dialysis during the study.
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 |
|---|---|---|
| OTAMIXABAN (XRP0673)Form: solution for injection Route: intravenous | Drug | Healthy population, Mild renal impairment population, Moderate renal impairment population, Severe renal impairment population |
Primary outcome
Pharmacokinetics of Otamixaban (Observed concentration at the end of the infusion (Ceoi) and Areas Under the plasma concentration Curve(AUClast and AUC))
Time frame: 4 days
1 secondary outcome
Pharmacodynamic effect based on coagulation parameters (activated Partial Prothrombin Time (aPTT), Prothrombin Time (PT) and International Normalized Ratio (INR))
Time frame: 4 days
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 12 May 2014.
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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.
Clinical Sciences & Operations study director
Sanofi
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 OTAMIXABAN (XRP0673) in people with Renal Impairment, run by Sanofi 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 7 inclusion and 9 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 12 May 2014. 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?
Pharmacokinetics of Otamixaban (Observed concentration at the end of the infusion (Ceoi) and Areas Under the plasma concentration Curve(AUClast and AUC)) (time frame: 4 days). 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 12 May 2014.