Genzyme Concludes Treat-to-Goal Study
Genzyme General announced on October 11 that it has concluded its Treat-to-Goal clinical trial comparing Renagel® (sevelamer hydrochloride) with calcium-based phosphate binders. At the recommendation of its clinical investigators and its Renagel medical advisory board, Genzyme elected not to pursue a two-year extension protocol because it felt the trial had met its objectives at one year.
Genzyme has submitted the trial results for publication in a prominent, peer-reviewed journal. It also plans to ask the U.S. Food and Drug Administration for permission to add the results to the Renagel product label.
The trial results will be presented October 13 by Glen Chertow, M.D., and Paolo Raggi, M.D., at a symposium sponsored by the University of Minnesota to be held during the ASN/ISN World Congress of Nephrology in San Francisco.
The Treat-to-Goal trial was a randomized, open-label study of Renagel and calcium salts (calcium acetate, calcium carbonate) in hemodialysis patients, designed to compare the effects of each on serum phosphorus, calcium, calcium-phosphorus product and intact parathyroid hormone levels for one year. The study protocol called for physicians to attempt to bring phosphorus, calcium, and parathyroid hormone levels into predetermined “goal” ranges.
In addition, all patients received an electron beam tomography (EBCT) scan at baseline and at weeks 26 and 52 to evaluate cardiovascular calcification. The Treat-to-Goal clinical program also included a separate two-year extension protocol. Patients who completed the 52-week protocol were given the option to enroll in the extension study.
“We have accomplished our objectives for the Treat-to-Goal study and are pleased to be moving forward with our efforts to publish the results and to work with the FDA to have them added to our label,” said Richard Moscicki, M.D., senior vice president and chief medical officer at Genzyme Corp. “Treat-to-Goal was an important component of the broad clinical development program for Renagel that also includes our D-COR and RIND studies. Patient enrollment in those trials has begun and is proceeding well.”
Dr. Chertow, who is an assistant professor at the University of California at San Francisco and the Treat-to-Goal study’s principal investigator, said: “The physicians who participated in this study felt there was little to be gained from continuing it for an additional two years. The study produced some compelling data.”
Renagel is a non-absorbed, calcium-free, aluminum-free phosphate binder that provides long-term phosphorus reduction in patients with end-stage renal disease on hemodialysis. Phosphorus reduction is critical to the quality of care of hemodialysis patients.
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