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

This study has been completed.
Information provided by (Responsible Party):
Cumberland Pharmaceuticals Identifier:
First received: April 23, 2009
Last updated: April 30, 2014
Last verified: April 2014
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.

Condition Intervention Phase
Kidney Diseases Hyponatremia Drug: conivaptan hydrochloride Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Open-Label Study to Assess the Effects of Renal Impairment on the Pharmacokinetics of Intravenous Conivaptan

Resource links provided by NLM:

Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:
  • Measure PK and protein binding of conivaptan [ Time Frame: 5 days ]

Secondary Outcome Measures:
  • Measure safety and tolerability of conivaptan [ Time Frame: 5 days ]

Enrollment: 25
Study Start Date: April 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Mild Renal Function Impaired Subjects Drug: conivaptan hydrochloride
Other Names:
  • Vaprisol
  • YM087
Experimental: 2. Moderate Renal Function Impaired Subjects Drug: conivaptan hydrochloride
Other Names:
  • Vaprisol
  • YM087
Experimental: 3. Subjects with Normal Renal Function Drug: conivaptan hydrochloride
Other Names:
  • Vaprisol
  • YM087


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00887627

United States, California
Anaheim, California, United States, 92801
Sponsors and Collaborators
Cumberland Pharmaceuticals
Study Director: Art Wheeler, MD Cumberland Pharmaceuticals Inc.
  More Information

Additional Information:
Responsible Party: Cumberland Pharmaceuticals Identifier: NCT00887627     History of Changes
Other Study ID Numbers: 087-CL-094
Study First Received: April 23, 2009
Last Updated: April 30, 2014

Keywords provided by Cumberland Pharmaceuticals:
Protein Binding
Kidney Diseases

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs processed this record on September 21, 2017