Clinical Trials

Inclusion Criteria

• Patients between 18 and 85 years old, inclusive
• Patients with end stage renal disease (ESRD) who are currently undergoing hemodialysis treatment through an upper extremity fistula
• Hemoglobin ≥8g/dL and platelet count ≥100,000/mm3 prior to Day 1
• Adequate liver function, defined as serum bilirubin ≤1.5 mg/dL; GGT, AST, ALT, and alkaline phosphatase ≤2x upper limit of normal or INR ≤ 1.5 prior to Day 0 or INR ≤ 2 if on anticoagulant therapy.
• Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures
• If female and of childbearing years, must have a negative serum pregnancy test at the screening visit (Visit 1). Both female patients of childbearing potential and male patients with childbearing potential partners must be willing to use contraception from the time of screening to completion of the study
• Life expectancy of at least 1 year

Exclusion Criteria

• Known sensitivity to Avastin or prior treatment with any medication known to target VEGF
• Current use of medications that are known to interact with the safety and efficacy of Avastin (most commonly: Antineoplastics (Anthracyclines), BCG, Belimumab, Bisphosphonate Derivatives, Clozapine, Dipyrone, Irinotecan, Sorafenib, and Sutent)
• History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months of study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
• Significant uncontrolled hypertension (systolic blood pressure above 160 mm Hg and/or diastolic blood pressure above 100 mm Hg);
• History or evidence of severe peripheral vascular disease in the upper limbs or known or suspected central vein obstruction on the side of fistula
• Stroke within six (6) months of study entry (Day 1)
• Treatment with any investigational drug/ device within 60 days prior to study entry (Day1)
• Treatment with vitamin K-antagonists or direct thrombin inhibitors with an INR ≥2
• All patients (including both female patients of childbearing potential and male patients with childbearing potential partners) who do not use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly), e.g. implants, injectables, combined oral contraceptives in combination with a barrier method, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner
• Malignancy or treatment for malignancy within the previous 6 months
• Immunodeficiency including AIDS / HIV
• Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events
• Bleeding diathesis
• Anemia with a hematocrit level of less than 30%
• A prothrombin time or a partial thromboplastin time more than 1.2 times the upper limit of normal, or absolute platelet counts below the lower limit of normal; an absolute neutrophil count below 1,500/mm3
• Active local or systemic infection (WBC > 15,000/mm3)
• Active autoimmune disease
• Patients receiving a lower extremity AV access
• Gastrointestinal ulcer or bleeding, or wound dehiscence
• Scheduled elective surgery within 2 months of start date
• Known serious allergy to aspirin or penicillin
• Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of Avastin
• Employees of the sponsor or patients who are employees or relatives of the investigator