Clinical Trial Details
| Trial ID: | L1426 |
| Source ID: | NCT02695641 |
| Associated Drug: | 1.25mg Bevacizumab |
| Title: | Reduction of Plasma Free VEGF-A Using Low-dose Bevacizumab in Hemodialysis Patients |
| Acronym: | |
| Status: | WITHDRAWN |
| Study Results: | NO |
| Results: | |
| Conditions: | End Stage Renal Disease|Hemodialysis Vascular Access Failure |
| Interventions: | DRUG: 1.25mg bevacizumab|DRUG: 2.50mg bevacizumab |
| Outcome Measures: | Primary: Change in Serum concentration of bevacizumab (nM), Obtained through serial blood draws and measured through ELISA., baseline, 4 weeks|Change in plasma free VEGF-A levels (pg/ml), Obtained through serial blood draws and measured through ELISA. ≥50% suppression from baseline retained by Day 15 will be considered successful., baseline, 4 weeks | Secondary: Safety Profile/ Adverse Events (NCI-CTCAE v. 4.0) monitoring, Monitoring of drug infusion reactions and adverse event development on subsequent follow-up visits at dialysis centers. Monitoring will include but will not be limited to allergic reactions or anaphylaxis, development of hypertension, excessive bleeding or thromboembolic events, 4 weeks |
| Sponsor/Collaborators: | Sponsor: Mayo Clinic |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | EARLY_PHASE1 |
| Enrollment: | 0 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER |
| Start Date: | 2019-08-01 |
| Completion Date: | 2021-11 |
| Results First Posted: | |
| Last Update Posted: | 2020-07-08 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT02695641 |

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