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Trial record 1 of 5 for:    ART-123
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Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01704001
First Posted: October 11, 2012
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation
  Purpose

To investigate the impact of impaired renal function on the pharmacokinetics of ART-123 in patients with Disseminated Intravascular Coagulation.

To investigate the safety of ART-123 in patients with Disseminated Intravascular Coagulation.


Condition Intervention Phase
Disseminated Intravascular Coagulation Drug: ART-123 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Post-Marketing Clinical Pharmacokinetics Study of ART-123 in DIC Subjects With Renal Impairment

Further study details as provided by Asahi Kasei Pharma Corporation:

Primary Outcome Measures:
  • Composite of Pharmacokinetics [ Time Frame: pre-dose, 0,2,4,8,24 hours post-dose ]
    Cmax, Area Under Curve, T1/2,CLtot,CLR

  • Incidence rate of hemorrhage related adverse events [ Time Frame: from the start of infusion to 8days after the cessation of infusion ]

Estimated Enrollment: 40
Study Start Date: October 2012
Study Completion Date: June 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal impairment grade 0 Drug: ART-123
380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
Other Name: Recomodulin™
Experimental: Renal impairment grade 1 Drug: ART-123
380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
Other Name: Recomodulin™
Experimental: Renal impairment grade 2 Drug: ART-123
380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
Other Name: Recomodulin™
Experimental: Renal impairment grade 3 Drug: ART-123
380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
Other Name: Recomodulin™

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Japanese Association for Acute Medicine-defined DIC criteria score >= 4
  • Written informed consent from patient or guardian

Exclusion Criteria:

  • Patients showing intracranial, pulmonary, gastrointestinal hemorrhage
  • Patients with a history of cerebrovascular disorders within the past 52 week
  • Patients with a history of hypersensitivity to the ingredients of ART-123 preparations
  • Pregnant women, nursing mothers or possibly pregnant women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704001


Locations
Japan
Oita, Japan
Sponsors and Collaborators
Asahi Kasei Pharma Corporation
  More Information

Responsible Party: Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier: NCT01704001     History of Changes
Other Study ID Numbers: ART-123 IV-2
First Submitted: October 1, 2012
First Posted: October 11, 2012
Last Update Posted: February 15, 2017
Last Verified: October 2012

Keywords provided by Asahi Kasei Pharma Corporation:
ART-123
Disseminated Intravascular Coagulation
Pharmacokinetics

Additional relevant MeSH terms:
Renal Insufficiency
Disseminated Intravascular Coagulation
Kidney Diseases
Urologic Diseases
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Thrombophilia