Evaluating the effectiveness of a new drug for treatment of diabetic kidney disease

The aim of this study is to see how effective the new drug (ASP8232) is in the treatment of diabetic kidney disease. The main finding of the study was that ASP8232 effectively reduced the amount of protein in the urine (a marker of kidney disease) in patients with diabetic kidney disease.

Diabetic kidney disease (nephropathy) is a common complication of diabetes. One of the ways to measure kidney disease is by the amount of protein in the urine (albuminuria). A test called urinary albumin/creatinine ratio (UACR) is used to estimate how much albumin is in the urine over 24-hours. The higher the UACR, the worse the kidney disease.

ASP8232 is a new drug being developed that blocks the inflammatory process in the kidney that causes kidney damage. It has improved kidney function in experimental studies. It is unknown whether ASP8232 can improve kidney function in patients with diabetic kidney disease.

This study included 120 patients with diabetic kidney disease. Patients were randomly assigned to either receive 40 mg of ASP8232 or a placebo every day for 12 weeks. Patients were followed for a further 24 weeks after treatment.

At 12 weeks of treatment, UACR decreased by 17.7% in the patients that received ASP8232. UACR increased by 2.3% in the placebo group. 

61% (39 patients) of the ASP8232 group and 56% (34 patients) of the placebo group experienced side effects. These included anemia, back pain, high blood pressure, kidney damage. Of these, 16 in the ASP8232 group and 4 in the placebo group were drug-related side effects. The most common side effects reported was decreased kidney function.

The authors concluded that ASP8232 is a safe and effective drug for reducing albuminuria in patients with diabetic kidney disease.

This was a phase 2 study. Further studies are needed to determine the safety and effectiveness of this drug. This study was funded by Astellas, the developer of ASP8232.