DuraLock-C Catheter Lock Solution

Exclusion Criteria

• •1\. Patients with an arteriovenous fistula or arteriovenous graft in use at the time of the study.
• •2\. Patients with a history of thromboembolic disease. 3. Patients with a history of HD catheter dysfunction due to thrombosis or a blood pump speed rate \<300 mL/min during HD in the past 30 days.
• •4\. Patients with uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding.
• •5\. Patients who received antibiotics within the last 14 days. 6. Have had an acute infection ≤ 30 days prior to enrollment. 7. Known allergy to heparin, including HIT. 8. Patients who received thrombolytic treatment (ie, tissue plasminogen activator \[tPA\]) within 4 weeks of enrollment.
• •9\. Patients using any type of antimicrobial-coated or heparin-coated catheter. 10. Have a positive serology test for human immunodeficiency virus or hepatitis infection.
• •11\. Current requirement for systemic immunosuppression that would increase risk of infection or any form of immunosuppressive disease.
• •12\. Patient is currently taking another medication with known systemic drug interaction with citrate or heparin.
• •13\. Patient is anticipated to receive a renal transplant within the study period should be excluded.
• •14\. Patients with known or suspected liver failure. 15. Are female and pregnant, lactating, or planning to become pregnant during the study period.
• •16\. Are currently participating in another interventional clinical study or has participated in another interventional clinical study in the past 3 months or previous enrollment in this study.
• •17\. Patient has a condition the investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk.
• •18\. Patient has an active malignancy of any type, or has been diagnosed with cancer within 5 years prior to screening (excluding squamous or basal cell carcinoma of the skin).
• •19\. Patient has a known allergy or history of significant adverse reaction to trisodium citrate or related compounds or to any of the excipients (citric acid).
• •20\. Any clinically significant abnormal laboratory test results found during medical screening, as determined by the investigator. NOTE: A test value above or below the normal range does not necessarily indicate that the value is "clinically significant." The determination should be made by the investigator.
• •21\. Have a history of noncompliance with HD as assessed by an investigator. 22. Have had a major cardiovascular or cerebrovascular event within 3 months of study entry.
• •23\. Are scheduled for living-donor transplantation within the study period, plan to change to peritoneal dialysis (PD) therapy within the study period, plan to change to a home HD treatment, or plan to relocate to an area where no study center is located.