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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00887627

Enrollment

Registered

2009-04-24

Start date

2009-04-30

Completion date

2010-07-31

Last updated

2014-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia, Kidney Diseases

Keywords

Pharmacokinetics, Protein Binding, Conivaptan, Vaprisol, Kidney Diseases

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.

Interventions

DRUGconivaptan hydrochloride

intravenous

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Measure PK and protein binding of conivaptan	5 days

Secondary

Measure	Time frame
Measure safety and tolerability of conivaptan	5 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026