CAMBRIDGE, Mass., Sept. 29 /PRNewswire-FirstCall/ -- Genzyme Corporation announced today that results from the Renagel in New Dialysis (RIND) study have been published in the October issue of Kidney International. Investigators in the RIND study compared the effects of Renagel(R) (sevelamer hydrochloride) with calcium-based phosphate binders for a period of 18 months in patients who were new to hemodialysis.
According to the study, each treatment group achieved the target levels for phosphorus and calcium-phosphorus product outlined in the 2003 National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines. The study found that patients with even mild preexisting coronary calcification who used calcium-based phosphate binders experienced more rapid and more severe progression of coronary artery calcification than those using Renagel. Patients without preexisting coronary calcification showed no increase, regardless of therapy.
The RIND study is a randomized, open-label trial that involved 129 patients new to dialysis at five dialysis centers in the United States. Investigators evaluated patients for coronary artery calcification at baseline and at six, 12, and 18 months using electron beam computed tomography.
Results demonstrated that 93 percent of patients with baseline coronary calcification using a calcium-based phosphate binder experienced greater than 15 percent progression in their level of coronary artery calcification over 18 months, with seven percent of calcium-treated patients experiencing no progression. In the Renagel arm, 60 percent of patients with baseline coronary calcification experienced progression of greater than 15 percent, while 40 percent experienced no progression. This difference between the two treatment groups was statistically significant.
Additionally, the median increase in scores used to calculate coronary artery calcification was 11 times greater in the calcium arm than in those treated with Renagel. Patients using Renagel were also significantly more likely to experience stabilization or regression in calcification at 12 and 18 months than were patients using calcium-based phosphate binders, according to the study.
"These results provide further evidence of Renagel's importance as a first-line therapy for patients who are new to dialysis," said principal investigator Geoffrey Block, M.D., of Denver Nephrologists, PC, Denver, Colorado. "By using Renagel from the time they began dialysis, patients in the RIND study achieved the K/DOQI targets for phosphorus and calcium-phosphorus product -- with a significantly lower progression and severity of coronary artery calcification than with calcium-based phosphate binders."
The Renagel in New Dialysis study was funded by Genzyme. Preliminary results were presented at the 2004 American Society of Nephrology meeting.
About Renagel
Renagel controls serum phosphorus in patients with Chronic Kidney Disease on hemodialysis. Controlling serum phosphorus is an important element in the care of hemodialysis patients. Elevated serum phosphorus levels are common in dialysis patients and associated with increased risk of cardiovascular mortality. Renagel provides the added benefit of significant LDL cholesterol reduction (32 percent).
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 the concerns of calcium or metal accumulation. Renagel is used by more than 350,000 people worldwide.
Product Labeling Information
Renagel is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on hemodialysis. Renagel is contraindicated in patients with hypophosphatemia or bowel obstruction. In a 52-week study, the most common side effects included vomiting, nausea, diarrhea, and dyspepsia. Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take Renagel. For more information about Renagel, including complete prescribing information, please visit http://www.renagel.com.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Founded in 1981, Genzyme has grown from a small start-up to a diversified enterprise with 7,600 employees in locations spanning the globe, and 2004 revenues of $2.2 billion. With many established products and services helping patients in more than 80 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopedics, cancer, transplant and immune diseases, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as heart disease and other areas of unmet medical need.
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