This trial is examining the safety and effectiveness of the new drug LMB763 in the treatment of diabetic kidney disease. The main outcome to be measured will be a change in kidney function. This study is being conducted in Florida and Oklahoma, the United States.
The details
Diabetic kidney disease is a common complication of diabetes. It results in gradually decreasing kidney function. Some patients may end up on dialysis for the remainder of their life. Standard treatment for patients with diabetic kidney disease includes a drug called an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB). Kidney function can be monitored by measuring the amount of protein in the urine (albuminuria). The more protein in the blood, the poorer the kidney function.
LMB763 is a new drug being developed for the treatment of diabetic kidney disease. It works by preventing inflammation, cell death, and scarring.
The purpose of this trial is to see how safe and effective LMB763 is in the treatment of diabetic kidney disease. The main outcomes to be measured will be a change in kidney function and side effects.
Who are they looking for?
This study is recruiting 100 participants. They must be have had diabetes for at least 6 months and be already on an ACEi or ARB drug.
Women must not be breastfeeding and must be willing to use effective contraception for the duration of the study. Subjects must not have any abnormal tracings of their heart (ECG) or a history of kidney disease other than diabetic kidney disease.
How will it work
Subjects will be randomly assigned to receive either LMB763 or a placebo for 24 weeks. Change in kidney function will be assessed by measuring the amount of protein in the urine. Any side effects that subjects experience will also be recorded.
