Clinical Research on Diabetic Nephropathy and Chronic Kidney Disease (CKD) and ESRD

There are several areas of ongoing clinical research activity in subjects with CKD and ESRD.

Samuel S. Blumenthal, MD, Barbara A. Bresnahan, MD, and Walter F. Piering, MD, FACP, are primarily involved in some of the following studies:

  • An open label double-blind controlled trials in progress evaluating its latest version of erythropoietin produced by a new manufacturing process (deep-tank technology).
  • A double-blind placebo controlled trial in CKD patients not yet on dialysis evaluating the efficacy of cinacalcet in treating secondary hyperparathyroidism. A long-term trial looking at the effects of this agent on preventing vascular calcification in patients on dialysis is in the planning stages.
  • In subjects with diabetic nephropathy, as part of our participation in the Collaborative Study Group headed by Dr. Edmund J. Lewis, we are studying the therapeutic potential of sulodexide to reduce albuminuria in patients with early (microalbuminuric) and late (overtly proteinuric) patients. Sulodexide seems to work by a different mechanism of action than ACE inhibitors or ARBs and in preliminary trials just completed, is safe and effective in reducing protein excretion in microalbuminuric patients. The current double-blind placebo controlled Phase III trials, seek to confirm this finding, as well as determine whether this agent prevents development of end-stage renal disease.
  • Several studies are being performed utilizing telmisartan for subjects with diabetic nephropathy. A study along the same lines has been completed in examining the effective of a combination of irbesartan and ramipril on patients with microalbuminuria.
  • Newer treatment options for the treatment of hypertension are being conducted at MCW. A novel new renin inhibitor, aliskiren, in patients with moderate hypertension is being investigated. A Phase II trial examining its new Type A endothelin receptor antagonist darusentan in patients with resistant hypertension. Several studies are evaluating the hypertensive efficacy of telmisartan. A study about to begin looks at control of BP over a 24-hour period in patients assigned to telmisartan vs valsartan.
  • The On-Target study is a five-year trial examines whether patients with ASHD or diabetic complications fare better in terms of CV end-points with ramipril/telmisartan/both. Another long-term study we are conducting is NAVIGATOR, a 4-arm DBRCT in subjects with the metabolic syndrome. Patients are randomized to valsartan/placebo and nateglinide/placebo. There are two separate sets of end-points: a rate of development of diabetes, and rate of CV complications.
  • A novel study utilizing Kremezin, a form of activated charcoal, can prevent progression of renal disease in patients with advanced renal failure not yet on dialysis is being investigated.

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