DuraLock-C Catheter Lock Solution

Inclusion Criteria:

• Males and non-pregnant females will be eligible for study entry provided that allinclusion/exclusion criteria are satisfied. Patients must fulfill all of the following inclusion criteria to be eligible forparticipation in the study:

1. Able to give informed consent after an explanation of the proposed study, and who arewilling to comply with the study requirements for therapy during the entire studytreatment period.
2. Patients undergoing HD 3 or 4 times per week in clinic (expected to continue for thelength of the study) with an established or newly placed non-tunneled or tunneled HDCVC as primary vascular access.
3. Adult male or female patients, aged ≥18 years at the time of screening.
4. Clinically stable as judged by the treating physician and as demonstrated by stablemedical history for 30 days prior to enrollment, physical examination, and laboratorytesting.
5. Expected to survive for the next 6 months and the patient is likely to require the useof a CVC for at least 90 days.
6. Females of childbearing potential must have a negative serum human chorionicgonadotropin (hCG) pregnancy test at screening

Exclusion Criteria:

• 1. Patients with an arteriovenous fistula or arteriovenous graft in use at the time ofthe study.

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