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Kidney Disease (also called Nephropathy) is one possible outcome of patients with Type 1 or 2 Diabetes. Up to 40% of Diabetes patients will face some degree of kidney disease. Leaving diabetes and kidney disease untreated or not monitored can lead to end stage renal disease and transplant if early intervention is not initiated.

What do blood sugar levels have to do with the kidneys? The kidneys work as the body’s filtering system. They break down the protein in the foods we eat and create waste products that are filtered out in urine. When blood glucose levels remain high for prolonged periods of time, this causes the kidneys to filter larger amounts of blood, causing strain on the kidneys. The kidney filters become weak and leak out useful proteins and lose their ability to properly filter waste products to the urine. These waste products build up in the blood stream and can cause the kidneys to fa

How can severe kidney damage be prevented? If you are Diabetic, in addition to controlling your blood sugar levels, chances are you may be on blood pressure medications as well. Many times, these medications are in a class of drugs called ACE Inhibitors or ARB’s (Angiotensin II Receptor blockers). You may be on one or the other or a combination of the two. These medications help to decrease constriction of the kidney blood vessels. In doing this, protein loss can be minimized. However, sometimes, kidney damage does continue and the patient starts developing large amounts of protein in the urine (proteinuria) and the UACR (Urine Albumin to Creatinine Ratio) level greatly increases. Sometimes more blood pressure medications are added. Sometimes diuretics are used to increase the volume of urine that a patient puts out. But, new treatments are being studied to see if there are other ways to prevent further kidney damage and possible dialysis or transplant scenarios.

One drug with potential being studied is an investigational medication called Atrasentan. Atrasentan is an oral medication that works to inhibit the cells that cause blood vessel constriction and may further prevent protein leakage into the urine. It is being tested whether Atrasentan in combination with the ACE/ARB medications and some diuretics will result in fewer events of kidney damage in Diabetic patients.

Atrasentan has been tested for this indication through many phases of the Clinical Trial process and the initial studies (Phase I and II Trials) have shown promise to reduce protein in the urine. The Phase III trial is called the SONAR Study (Study of Diabetic Nephropathy with Atrasentan) and is being conducted here right in the West Palm Beach area at Metabolic Research Institute under the direction of Dr. William Kaye and Dr. Barry Horowitz, co-medical directors.

Patients who have diabetes and kidney disease can possibly qualify for the SONAR study need to be between the ages of 18 and 85, a type 2 Diabetic on an ACE or ARB, have a history of high UACR levels (300 mg/g to 5000 mg/g) and have no history of heart failure. Patients who qualify will be randomized (chosen automatically/arbitrarily) to receive either Atrasentan or a matching placebo that looks like Atrasentan but has no active ingredients. Placebos are often used in Phase III Trials to prevent bias and ensure that any adverse effects reported are easily able to be distinguished as possibly drug-related or not. Neither you nor the doctors will know which the patient is taking, however, research participants are monitored by the doctor and study staff and can stop participation at any time. In addition, all effects are reported to all participants so that they may make an informed decision as to whether or not they choose to continue on the trial.

Many research participants report that they enjoy taking an active part in research and appreciate having a dedicated research staff to monitor them. There is no cost to the participant to enroll. All medications, blood work, exams and other research-related procedures are provided by Metabolic Research Institute and the drug company that sponsors the trial. Participants will receive a small stipend for their time and travel.

If you would like more information about clinical trials for Diabetes and Kidney Disease, please call us at 561-802-3060.

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