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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00543075 |
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Date of registration:
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10/10/2007 |
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Primary sponsor: |
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Public title:
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Pharmacokinetic Study of Genasense in Subjects With Normal Renal Function, Mildly Impaired Renal Function, and Moderately Impaired Renal Function
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Scientific title:
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A Phase I Pharmacokinetic Study of Genasense® in Subjects With Normal Renal Function and Mildly and Moderately Impaired Renal Function |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00543075 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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Countries of recruitment
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United States
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Contacts
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Name:
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Harry Alcorn, PharmD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Davita Clinical Research |
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Key inclusion & exclusion criteria
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Key inclusion criteria:
- 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:
- 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
Age minimum:
18 Weeks
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Mildly Impaired Renal Function
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Moderately Impaired Renal Function
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Normal Renal Function
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Intervention(s)
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Drug: Genasense (oblimersen, G3139)
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Primary Outcome(s)
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Pharmacokinetics of oblimersen (G3139)
[Time Frame: Up to 58 hours after start of Genasense infusion]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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