Reduction of Plasma Free VEGF-A Using Low-dose Bevacizumab in Hemodialysis Patients
NCT02695641 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL
Last updated 2020-07-08
Summary
The primary purpose of this pilot study is to assess the pharmacokinetic profile of low-dose bevacizumab and its effectiveness in reducing plasma free VEGF-A levels safely in hemodialysis patients. This information will be used to plan a phase 1 clinical trial evaluating bevacizumab's role in hemodialysis vascular access failure.
Conditions
- End Stage Renal Disease
- Hemodialysis Vascular Access Failure
Interventions
- DRUG
-
1.25mg bevacizumab
Bevacizumab is a monoclonal antibody against VEGF-A. 1.25mg in 50ml 0.9% Sodium Chloride will be administered once as an intravenous infusion over 30 minutes.
- DRUG
-
2.50mg bevacizumab
Bevacizumab is a monoclonal antibody against VEGF-A. 2.50mg in 50ml 0.9% Sodium Chloride will be administered once as an intravenous infusion over 30 minutes.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Sanjay Misra, MD · Mayo Clinic
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-01
- Primary Completion
- 2020-08-31
- Completion
- 2021-11-30
- FDA Drug
- Yes
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