A Study to Evaluate the Pharmacokinetics of Low-Dose Bevacuzimab in Reducing Free Plasma VEGF-A in Hemodialysis Patients

Overview

About this study

The purpose of this study is to see how hemodialysis patients respond to a very low dose of Avastin (bevacizumab) by measuring the concentration of the medication in the blood and determine how it affects a certain protein that we believe is partially responsible in the vascular narrowing process.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Sanjay Misra, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20192468

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