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The MANEUVER Study


Title VEGF-B Blockade with the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
Therapeutic Area Type II Diabetes, Kidney Diseases
Principal Investigator Daniel Weiner, MD MS
Min Age 25 Years
Gender All
Contact Leah Meyer
617-636-5985
lmeyer@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04419467

Overview

This is the first study to look at a new medicine to help kidneys in people with diabetes who have protein in their urine. It looks at the safety and the effect on the amount of protein in the urine of a blocker of ‘Vascular Endothelial Growth Factor (VEGF)-B’. Information from animal studies suggests that blocking VEGF-B could help protect cells in the kidney from the damaging effects of diabetes. The drug is given either through the vein or under the skin by research nurses under the supervision of a research doctor. Some participants will get the medications while others will get a placebo (salt water); this will be decided randomly by chance.

Study Details

Inclusion Criteria

  • Age 25 or older
  • Type 2 diabetes
  • Protein in the urine (urine albumin to creatinine ratio ≥150 mg/g)

Exclusion Criteria

  • Advanced kidney disease
  • Uncontrolled diabetes or blood pressure
  • Recent heart disease

Study Requirements

The study lasts about 34 weeks, including a 12 week period where people in the study get the medicine every 4 weeks, for a total of 4 doses. In the first few weeks, there is a visit weekly, but these are less frequent as the study goes on, spacing out to 8 weeks at the end.

There are no x-rays or scans but everyone will have an electrocardiogram (EKG) and an echocardiogram (heart ultrasound)

There are frequent urine samples and blood draws (about 1 or 2 tablespoons of blood per visit).

Some visits will be about an hour, but the 4 visits where you get medicine will each take a few hours.