Impaired Renal Function Clinical Trials

 

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eBulletin  |  October 2013

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Impaired Renal Function Clinical Trials
Successful Enrollment Through Collaboration

Algorithme Pharma recently collaborated with Hôpital Maisonneuve-Rosemont (HMR), in a joint clinical trial with the successful enrollment of patients with impaired renal function. Patients with moderate and severe renal impairment were enrolled at the nephrology department at HMR under the supervision of Dr. Vincent Pichette, MD, PhD, nephrologist. In parallel, patients with mild renal impairment were enrolled at Algorithme Pharma, under the supervision of Dr. Eric Sicard, MD, Principal Investigator. A control group of healthy participants with normal renal function were matched (by age, weight, etc.) with renal impaired patients. This was required as a baseline renal function in the assessment of the investigational drug. Full enrollment was completed in 10-weeks and included 24 patients with mild, moderate and severely impaired renal function.

In this trial, the drug was administered at the same dose level to groups with mild, moderate and severely impaired renal function. This allowed for dosage adjustment recommendations to be made for patients based on measures of renal function. The dose levels were classified using the estimated glomerular filtration rate (eGFR) as established by the Food and Drug Administration (FDA) in its guidance for this study type.

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Algorithme Pharma has developed strategic relationships with major hospitals in the Greater Montreal area, including multiple external investigators, for the conduct of clinical trials involving varying patient populations. Depending on study requirements, we have the flexibility to conduct the clinical portion of a study at a hospital's clinical research unit, at Algorithme Pharma or both.

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