Both Forth Bridges

Hepatic and Renal Impairment / NASH

Clinical Pharmacology of Miami is a proven and trusted resource for the conduct of trials involving patients with hepatic and renal impairment, including nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).  The company’s founders, Kenneth Lasseter, M.D., Stacy Dilzer, R.N., B.S.N., and Cooper Shamblen, have over 100 years of combined experience managing these clinical studies and providing extensive outreach in their community to identify appropriate patients for trials.

The staff of CPMI has maintained a population of patients with Hepatic Impairment for a number of years. The size of this population varies but averages between 30 -50 patients at any given time. Most of these patients are cirrhotic patients as a result of alcohol abuse and are classified as either Child-Pugh A or Child-Pugh B. Our ability to recruit Child-Pugh C (severely impaired) patients is limited by the fact that these subjects are usually quite sick and not able to participate in studies. Nevertheless our population of patients has allowed us to complete a number of FDA mandated studies every year according to the guidance that they have published. CPMI has also been able to identify NASH patients with documented diagnosis based on MRI and/or ultrasound.

CPMI has also maintained a population of patients with Renal Impairment for a number of years. The size of this population averages between 50 -60 patients at any given time. Most of these patients result from our intensive screening programs and are classified as either mild (GFR 50-80 ml/min) or moderately (GFR 20-50 ml/min} impaired. Our ability to recruit severely impaired patients (GFR less than 30 ml/min) is limited by the fact that most of these subjects go on a transplant list and are placed on dialysis in our community but we still have been able to identify and study enough of these subjects every year to complete a number of FDA mandated studies according to the guidance that they have published. Studies with ESRD patients requires collaboration with a dialysis center or other investigator.

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