Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function

Kidney Diseases Clinical Trial

Official title:

A Phase 1, Open-Label Study to Assess the Effects of Renal Impairment on the Pharmacokinetics of Intravenous Conivaptan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887627
• Other study ID #: 087-CL-094
• Status: Completed
• Phase: Phase 1
• First received: April 23, 2009
• Last updated: April 30, 2014
• Start date: April 2009
• Est. completion date: July 2010

Study information

• Verified date: April 2014
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hyponatremia
• Kidney Diseases

Intervention

Drug:
• conivaptan hydrochloride
intravenous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure PK and protein binding of conivaptan		5 days	No
Secondary	Measure safety and tolerability of conivaptan		5 days	No

External Links

•   Link to results on JAPIC