Chronic Kidney Disease Study

WHAT IS EPPIC

EVALUATING THE PREVENTION OF PROGRESSION IN CHRONIC KIDNEY DISEASE (CKD)

EPPIC is being conducted to evaluate whether adding the investigational study medication to the routine therapy in moderate to severe CKD reduces the time to initiation of dialysis. kidney transplant or doubling of serum creatinine levels (which is measured from a blood sample and gives an indication of the status of the kidney function) when compared to placebo (which is an inactive mock medication). Creatinine is a serum measure of kidney function - the higher the serum creatinine, the worse the kidney function. The study medication was approved for marketing in Japan in 1991. It has been shown in research studies to lower the level of kidney toxins in the blood in both animals and humans. In doing this it has been shown to slow the progression of kidney failure as measured by creatinine blood levels, and to increase the amount of time before dialysis was needed. Since the incidence of end stage kidney disease continues to increase. new agents capable of altering the rate of decline in kidney function are needed to provide more treatment options for people with CKD for the future.

Approximately 800 people will participate in this study. If you decide to participate in the study, your participation will continue far up to 3.5 years or until you need dialysis, a transplant or the study is completed or terminated by the sponsor. It is very important that you remain in the study for this time to make sure that sufficient data is gathered. However, you will also be free to end your participation in the study at any time and your doctor can also decide to end your participation for safety reasons.

HOW CAN I PARTICIPATE?

To quality for the study, you must meet the following requirements:

·Age 18 years or older ·Moderate to severe CKD. Not anticipated to require dialysis or kidney transplant within the next 6 months

·Serum Creatinine 2.0 mg-dl - 5.0 mg dl: (177 µmol/L - 442 µmol/L)

·No more than 1 blood pressure reading of 160/90 mmHg in the past 3 months

·There are other criteria relating to your general medical condition that your physician will discuss with you before determining if you are able to participate in the study.

HOW WILL THIS STUDY BENEFIT ME?

Study participation includes a study related evaluation and kidney disease assessment, which may provide you and your doctor with additional information about your health. Additionally, you will receive these study related benefits:

· Prior to the study, you will receive information about CKD, the study medication, and have an opportunity to discuss your condition with study staff.

· During study visit you will be given personal attention, instruction on using the study medication, tools to help with study related procedures, educational material on kidney health and tests to monitor kidney function,

· You will be provided study medication or placebo during your participation in the study at no charge to you.

The results from previous Japanese studies suggest that study medication can be effective in lengthening the time to the start of dialysis. Although study medication has helped some Japanese patients, there is no guarantee that you will benefit from your participation in the study. Your participation may provide information about the study drug that may benefit others in the future. The results from this study may help other people who also have CKD and it may help to develop new drugs to treat CKD in the future.