The purpose of this clincial trial is to see if the drug CSL346 (developed by CSL Behring) is safe and effective in treating type II diabetic kidney disease. We will look at whether the drug decreases the amount of protein in your urine. The drug is given through the vein and under the skin by research nurses under the supervision of the research doctor. This study is double-blind and placebo-controlled, meaning that neither you nor the study team will know if you are assigned to take the real drug or a saline solution. There is a 50% chance that you will recieve the drug.
- Type 2 diabetes diagnosis
- Protein in the urine (urine albumin to creatinine ratio >150 mg/g). We will test this, so it is okay if you haven't had it done in the past.
- Advanced stage kidney disease
- Uncontrolled diabetes or blood pressure
- Diagnosed heart disease
If you aren't sure you qualify, please call us and we will help determine your eligibility.
The study consists of 11 visits over 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.