Status:
COMPLETED
Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function
Lead Sponsor:
Cumberland Pharmaceuticals
Conditions:
Kidney Diseases
Hyponatremia
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
A study to compare a conivaptan PK in subjects with mild or moderate kidney function impairment to subjects with normal kidney function after a 48-hour continuous infusion of conivaptan.
Eligibility Criteria
Inclusion
- Weighs at least 45 kg
- Body mass index between 18 and 40 kg/m2 inclusive
- Must be in good health other than renal function impairment and related stable diseases for the renal impaired subjects
- Must have a screening and pre-dose estimated glomerular filtration rate (GFR) that corresponds with the level of renal impairment based on the abbreviated Modification of Diet in Renal Disease (MDRD) formula
- Female subject of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test, utilizes adequate contraceptive methods while in this study or may be surgically sterile and/or two years post menopausal
Exclusion
- Subject is known to be HIV positive or has HIV antibodies
- Has clinically significant history or presence of illness, medical condition, or laboratory abnormality
- Is Hepatitis positive
- Subject with renal impairment has not been on a stable dose of concomitant medications for at least 4 weeks prior to start of study and/or dose changes are likely during the study
- History of substance abuse within 6 months prior to screening
- Has clinically significant history or presence of psychiatric illness, malignancy, or immunodeficiency syndrome
- Has abnormal liver function tests (ALT, AST, and/or bilirubin)
- Has had a blood transfusion or donated/lost more than 450ml of blood within 56 days of study drug administration or has donated plasma within 7 days prior to study drug administration
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00887627
Start Date
April 1 2009
End Date
July 1 2010
Last Update
May 2 2014
Active Locations (1)
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1
Anaheim, California, United States, 92801