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Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Asahi Kasei Pharma Corporation.
Recruitment status was:  Recruiting
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

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
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:
Renal Insufficiency
Disseminated Intravascular Coagulation
Kidney Diseases
Urologic Diseases
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Thrombophilia

ClinicalTrials.gov processed this record on December 07, 2016