Trial record 1 of 4 for:    ART-123
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Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment

This study is currently recruiting participants.
Verified October 2012 by Asahi Kasei Pharma Corporation
Sponsor:
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01704001
First received: October 1, 2012
Last updated: October 16, 2012
Last verified: October 2012
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Post-Marketing Clinical Pharmacokinetics Study of ART-123 in DIC Subjects With Renal Impairment

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01704001

Contacts
Contact: Asahi Kasei Pharma Corporation 81-(0)3-3296-5337 ct-info@om.asahi-kasei.co.jp

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

No publications provided

Responsible Party: Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier: NCT01704001     History of Changes
Other Study ID Numbers: ART-123 IV-2
Study First Received: October 1, 2012
Last Updated: October 16, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

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

ClinicalTrials.gov processed this record on April 16, 2014