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

Kidney Failure, Chronic Clinical Trial

Official title:

Pharmacokinetics and Pharmacodynamics of Argatroban Injection in End-Stage Renal Disease (ESRD) Patients Undergoing Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035178
• Other study ID #: ARG-402
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2002
• Last updated: June 23, 2005
• Start date: May 2002
• Est. completion date: November 2002

Study information

• Verified date: December 2003
• Source: Encysive Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure, Chronic
• Renal Disease, End-Stage
• Renal Insufficiency

Intervention

Drug:
• Argatroban

Locations

Country	Name	City	State
United States	University of Chicago, Section of Nephrology	Chicago	Illinois
United States	DaVita Clinical Research	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Texas Biotechnology Corporation

Country where clinical trial is conducted

United States,