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Pharmacokinetics/Pharmacodynamics of Argatroban Injection in End-Stage Renal Disease Patients Undergoing Hemodialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00035178
First Posted: May 3, 2002
Last Update Posted: June 24, 2005
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:
Encysive Pharmaceuticals
  Purpose
The primary goals of this investigation are to provide guidance on how to dose Argatroban in patients undergoing hemodialysis and to assess the safety and tolerability of Argatroban in hemodialysis patients. The secondary goal of the study will be to assess the adequacy of anticoagulation during hemodialysis.

Condition Intervention Phase
Kidney Failure, Chronic Renal Disease, End-Stage Drug: Argatroban Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Pharmacodynamics of Argatroban Injection in End-Stage Renal Disease (ESRD) Patients Undergoing Hemodialysis

Resource links provided by NLM:


Further study details as provided by Encysive Pharmaceuticals:

Estimated Enrollment: 12
Study Start Date: May 2002
Estimated Study Completion Date: November 2002
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Basic Inclusion Criteria:

  1. Patients, adult men or women who are between 21 and 75 years of age who are on maintenance hemodialysis regimen for at least three (3) months prior to the study start.
  2. Patients who can tolerate a hemodialysis session lasting up to 9 hours.
  3. Patients who can tolerate a hemodialysis treatment with blood flow rates of 300 ml per minute.
  4. Female volunteers who are not documented to be surgically sterile must be willing to abstain from sexual intercourse during the study or be willing to use intrauterine devices or 2 forms of barrier contraception for at least 7 days prior to the initial dose of study medication and continuing through the completion of the study.

Basic Exclusion Criteria:

  1. Any clinically relevant abnormality identified per the investigator on the screening medical assessment or laboratory examination.
  2. History of regular alcohol abuse.
  3. Treatment with an investigational drug within 30 days.
  4. History of drug allergy of clinical significance in the opinion of the investigator.
  5. Currently taking warfarin or other anticoagulants.
  6. Currently taking NSAIDs (with the exception of aspirin).
  7. Individuals who are obese.
  8. Any history of bleeding disorder.
  9. Any subject with a screening resting systolic blood pressure >180 mmHg and/or resting diastolic blood pressure of >100 mmHg unless, in the opinion of the principal investigator, the blood pressures would not endanger the subject while participating in this trial.
  10. Concurrent uncontrolled cardiovascular, hematologic, respiratory, CNS, gastrointestinal disease or chronic alcoholism.
  11. Anemia defined as a hematocrit of < 30 and hemoglobin < 10g/dL.
  12. Concurrently taking (within the past 30 days) phenytoin, cimetidine, rifampin, cyclosporin or tacrolimus.
  13. Known hypersensitivity to Argatroban or related compounds.
  14. Significant hepatic insufficiency as defined by total bilirubin greater than 1.5 mg/dL or transaminase (ALT, AST) elevations greater than 2 times the upper limit of the laboratory reference range.
  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): NCT00035178


Locations
United States, Illinois
University of Chicago, Section of Nephrology
Chicago, Illinois, United States, 60637
United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Texas Biotechnology Corporation
  More Information

ClinicalTrials.gov Identifier: NCT00035178     History of Changes
Other Study ID Numbers: ARG-402
First Submitted: May 2, 2002
First Posted: May 3, 2002
Last Update Posted: June 24, 2005
Last Verified: December 2003

Keywords provided by Encysive Pharmaceuticals:
ESRD
End-stage renal disease
Hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Argatroban
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Platelet Aggregation Inhibitors