Normal Renal FunctionPhase 1NCT00543075
Pharmacokinetic Study of Genasense in Subjects With Normal Renal Function, Mildly Impaired Renal Function, and Moderately Impaired Renal Function
A Phase 1 study testing Genasense (oblimersen, G3139) in people with Normal Renal Function and Mildly Impaired Renal Function, run by Genta Incorporated at 1 site in United States.
Trial summary
To characterize the pharmacokinetics of G3139 in subjects with normal, mildly impaired, and moderately impaired renal function who receive Genasense 3 mg/kg/day by continuous intravenous infusion for 2 days (48 hours). Read more about this study
- Who is it for?
- Ages 18 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Renal Function, Mildly Impaired Renal Function, Moderately Impaired Renal Function
- What is being tested?
- Genasense (oblimersen, G3139)
- Type of treatment
- Injection or infusion
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Sep 2009
- 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 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age > 18 years
- Adequate organ function as determined < 7 days prior to starting study medication (except for renal function, as specified per protocol)
- Creatinine clearance > 80 mL/min based on the Cockcroft-Gault formula for subjects in Group 1; or 50 to less than or equal to 80 mL/min based on the Cockcroft-Gault formula and confirmed based on measured creatinine clearance for subjects in Group 2; or 30 to 49 mL/min based on the Cockcroft-Gault formula and confirmed based on measured creatinine clearance for subjects in Group 3
Who cannot join
- Significant medical disease
- Prior organ allograft
- Coexisting condition that would require the subject to continue therapy during the treatment (infusion) phase of the study with a drug known to alter renal function
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 I Pharmacokinetic Study of Genasense® in Subjects With Normal Renal Function and Mildly and Moderately Impaired Renal Function
To characterize the pharmacokinetics of G3139 in subjects with normal, mildly impaired, and moderately impaired renal function who receive Genasense 3 mg/kg/day by continuous intravenous infusion for 2 days (48 hours).
- Being tested
- Genasense (oblimersen, G3139)
- Keywords
- Renal Function, Adult, Genasense, oblimersen, G3139, Genta, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genasense (oblimersen, G3139)Drug
Also called Oblimersen, G3139
3 mg/kg/day by intravenous infusion for up to 48 hours
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of oblimersen (G3139)
Measured: Up to 58 hours after start of Genasense infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startMay 2006
- Primary completionNov 2007
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Renal FunctionStudies 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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genta Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harry Alcorn, PharmD, Principal investigator, Davita Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543075
- Sponsor's protocol ID
- GPK104
- Status last verified
- Jun 2008
- First submitted
- 10 Oct 2007
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Pharmacokinetic Study of Genasense® in Subjects With Normal Renal Function and Mildly and Moderately Impaired Renal Function
- ClinicalTrials.gov ID
- NCT00543075
- Acronym / sponsor ID
- GPK104
- Keywords
- Renal Function, Adult, Genasense, oblimersen, G3139, Genta, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Genta IncorporatedIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 12 Oct 2007 (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.
To characterize the pharmacokinetics of G3139 in subjects with normal, mildly impaired, and moderately impaired renal function who receive Genasense 3 mg/kg/day by continuous intravenous infusion for 2 days (48 hours).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Adequate organ function as determined < 7 days prior to starting study medication (except for renal function, as specified per protocol)
- Creatinine clearance > 80 mL/min based on the Cockcroft-Gault formula for subjects in Group 1; or 50 to less than or equal to 80 mL/min based on the Cockcroft-Gault formula and confirmed based on measured creatinine clearance for subjects in Group 2; or 30 to 49 mL/min based on the Cockcroft-Gault formula and confirmed based on measured creatinine clearance for subjects in Group 3
Key exclusion criteria (3 listed)
- Significant medical disease
- Prior organ allograft
- Coexisting condition that would require the subject to continue therapy during the treatment (infusion) phase of the study with a drug known to alter renal function
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 |
|---|---|---|
| Genasense (oblimersen, G3139)Also: Oblimersen, G31393 mg/kg/day by intravenous infusion for up to 48 hours | Drug | – |
Primary outcome
Pharmacokinetics of oblimersen (G3139)
Time frame: Up to 58 hours after start of Genasense infusion
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 13 Mar 2012.
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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, PharmD 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 Genasense (oblimersen, G3139) in people with Normal Renal Function and Mildly Impaired Renal Function, run by Genta Incorporated 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 3 inclusion and 3 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 13 Mar 2012. 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?
Pharmacokinetics of oblimersen (G3139) (time frame: Up to 58 hours after start of Genasense infusion). 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 13 Mar 2012.