Christina Kahn, senior director of site alliance management at Frenova Renal Research, a contract research organization (CRO) dedicated to renal research, said Louisiana was a strategic choice.
“Louisiana unfortunately has a high prevalence of kidney disease and comorbid conditions, such as diabetes and hypertension,” she told us. “That combined with the highly engaged roster of physicians in Dr. Roppolo’s practice made it an ideal choice for us to add to our site management organization.”
The site is located in Baton Rouge, LA and provides access to 6,000 kidney disease patients and 1,500 end-stage renal disease patients. The site will be the fifth site among the Frenova site management organization (SMO).
Michael Roppolo of the Renal Associates of Baton Rouge will lead the site as principal investigator. The site has three principal investigators and 10 sub-investigators. Frenova will have clinical staff on-site, said Kahn, allowing the company to train staff and manage operations.
“Frenova manages all of the operational details of a clinical trial, including the pre-negotiation of agreements, documentation handling, patient enrollment, protocol designs and pre-screening patients using our database,” said Kahn.
The research site also will join the F1RST Up (Frenova Rapid Start Up) Alliance. The alliance aims to simplify and expedite the startup of clinical trials investigating renal health care.
Kahn told us, “There are particular challenges in conducting renal-related clinical studies. F1RST Up is a select group of clinical research sites staffed by industry experts in CKD and ESRD that help companies get their renal research studies started faster.”
F1RST Up specializes in vascular access and care, cardio-renal conditions, chronic kidney disease (CKD) and end-stage renal disease (ESRD). The site alliance provides sponsors access to a large network of CKD patients and ESRD patients as well as historical data on hundreds of thousands of patients with kidney disease.