Genzyme Corporation announced that investigators tomorrow will unveil new preliminary data supporting the use of Renagel (sevelamer hydrochloride) in patients who are new to hemodialysis.
The data, drawn from the recently completed Renagel in New Dialysis (RIND) study, compare the clinical experiences of new dialysis patients on Renagel with those on calcium-based phosphate binders for a period of 18 months.
Investigators will report during a symposium at the American Society of Nephrology meeting in St. Louis that the RIND study data show a significant difference in the primary endpoint -- change in coronary artery calcification over 18 months -- between patients using calcium-based phosphate binders and those using Renagel. Results show that the change in coronary artery calcification scores was significantly greater in the calcium-based phosphate binder group than in the Renagel group.
The RIND data also show that, consistent with the findings of the earlier Treat-to-Goal study, patients using both types of phosphate binders were able to achieve target levels for phosphorus and calcium-phosphorus product as outlined in the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines.
Full data will be submitted for publication in a peer-reviewed medical journal.
"The preliminary results we have seen in the RIND study underscore Renagel's role as a first-line treatment option for patients beginning dialysis," said principal investigator Geoffrey Block, M.D., of Denver Nephrologists, PC, Denver, Colorado. "This study shows that by using Renagel from the time they begin dialysis, patients can achieve the K/DOQI targets for phosphorus and calcium-phosphorus product -- with a significantly lower progression of coronary artery calcification than with calcium-based phosphate binders."
The Genzyme-funded RIND study is a randomized, open-label trial that involved 129 patients who were new to dialysis. Investigators evaluated patients for coronary artery calcification at baseline and at six, 12, and 18 months using electron beam computed tomography.
The clinical impact of the coronary artery calcification scores -- including the differences noted between treatment groups -- has not been demonstrated. Through the Dialysis Clinical Outcomes Revisited (D-COR(SM)) trial, investigators are currently examining the difference in morbidity and mortality outcomes for patients receiving Renagel and those receiving calcium- based phosphate binders. The first results are expected from this study in mid-2005.
Renagel helps to control serum phosphorus in patients with Chronic Kidney Disease on hemodialysis. The National Kidney Foundation's 2003 K/DOQI guidelines for Bone Metabolism and Disease in Chronic Kidney Disease recommend sevelamer hydrochloride as a first-line treatment option to reduce phosphorus. Renagel is the only phosphate binder available that does not contain either calcium or a metal. It has an established safety profile, is not systemically absorbed and provides phosphorus control without concerns of calcium or metal accumulation.