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1. Newly Approved Drug Therapies (1051) Renagel (sevelamer hydrochloride), Genzyme, ...hydrochloride) Company: Genzyme Approval Status: Approved July of 2000 Treatment Area: the control of serum phosphorus in patients with chronic kidney disease on dialysis General Information Renagel is a polymeric amine ......and prevents phosphate from being absorbed. Renagel is specifically indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Renagel is supplied as 400 mg and ...View Page
2. Newly Approved Drug Therapies (1062) Renvela (sevelamer carbonate), Genzyme, ...Renvela (sevelamer carbonate) Company: Genzyme Approval Status: Approved October 2007 Treatment Area: control of serum phosphorus in patients with chronic kidney disease on dialysis General Information Renvela contains sevelamer carbonate, a ......the phosphate concentration in the serum. Renvela is specifically indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Renvela is supplied as a tablet designed ...View Page
3. Newly Approved Drug Therapies (640) Renagel (sevelamer hydrochloride), GelTex Pharmaceuticals, ...in 800 mg and 400 mg doses for the treatment of high levels of serum phosphorus in patients with end-stage renal disease (ESRD). It is available by prescription only. The ......for the same indication, but in a capsule formulation. Hyperphosphatemia is characterized by elevated serum phosphorus levels, a substance typically excreted through normal digestive processes. If left untreated, hyperphosphatemia can lead ...View Page
4. Study Posting (799) Trial #151213, Kidney Disease, Boston, MA ...that often develops in patients who have kidney disease and (2) to test whether decreasing phosphorus intake could help improve or prevent hyperparathyroidism. Eligible subjects will be people with reduced kidney ......over approximately one month. For two weeks during this time, subjects will consume a controlled phosphorus diet provided by the clinical research center. Some subjects will be prescribed a phosphorus binding ...View Page
5. CenterWatch: New Medical Therapies in Disease Category (116), Parathyroid Disorders ...for the treatment of hyperparathyroidism (HPT). Results showed a 13 to 17 % reduction in calcium-phosphorus product, a 6-8% reduction in calcium and a 7-10% reduction in phosphorus compared to baseline levels after standard therapy and placebo. Data showed that 36 to 48% ...View Page
6. CenterWatch: New Medical Therapies in Disease Category (266), Parathyroid Disease ...for the treatment of hyperparathyroidism (HPT). Results showed a 13 to 17 % reduction in calcium-phosphorus product, a 6-8% reduction in calcium and a 7-10% reduction in phosphorus compared to baseline levels after standard therapy and placebo. Data showed that 36 to 48% ...View Page
7. Study Posting (168) Trial #75328, Renal Artery Disease, Hollywood, FL ...Parallel Arm, Comparison Study of Calcium Acetate + Atorvastatin and Sevelamer +/- Atorvastatin on Cardiovascular Calcification and Phosphorus Levels in Patients with End-Stage Renal Disease. For more information, Sheila Hirsch Horizon Institute ...View Page
8. Newly Approved Drug Therapies (507) RenaGelRenagel (sevelamer hydrochloride), GelTex Pharmaceuticals, ...in patients with end stage renal disease. Mechanism of Action The agent acts by binding phosphorus in the gastrointestinal tract and allows elimination of phosphorus through normal digestive processes. Jobson Medical Information • Privacy | • Glossary Copyright © 1995-2010 Jobson Medical Information ...View Page
9. Newly Approved Drug Therapies (693) PhosLo, Braintree Laboratories, ...dietary manipulation is insufficient. Clinical Results Studies have confirmed that using calcium acetate as a phosphorus binder will control serum phosphorus levels in most dialysis outpatients. Side Effects Adverse events associated with the use of PhosLo ...View Page
10. CenterWatch: Nephrology/Urology Approved Drug Therapies ...chronic renal failure, Approved November 2007 Renvela (sevelamer carbonate) ; Genzyme; For the control of serum phosphorus in patients with chronic kidney disease on dialysis, Approved October 2007 Torisel (temsirolimus) ; Wyeth; For ......kidney rejection, Approved August 2000 Renagel (sevelamer hydrochloride) ; GelTex Pharmaceuticals; For the reduction of serum phosphorus in patients with end-stage renal disease (ESRD), Approved July 2000 Renagel (sevelamer hydrochloride) ; Genzyme ...View Page
11. Newly Approved Drug Therapies (611) AndroGel testosterone gel, Unimed Pharmaceuticals, ...testosterone, AndroGel, like other drugs in its class, may promote retention of nitrogen, sodium, potassium, phosphorus, and decreased urinary excretion of calcium. Furthermore, it may increase protein anabolism and decrease protein ...View Page
12. CenterWatch: List of Newly Approved Drug Thearapies ...of hemophilia A, Approved June 2000 Renagel (sevelamer hydrochloride) ; Genzyme; For the control of serum phosphorus in patients with chronic kidney disease on dialysis, Approved July of 2000 Venofer (iron sucrose ......kidney rejection, Approved August 2000 Renagel (sevelamer hydrochloride) ; GelTex Pharmaceuticals; For the reduction of serum phosphorus in patients with end-stage renal disease (ESRD), Approved July 2000 Renagel (sevelamer hydrochloride) ; Genzyme ...View Page
13. Newly Approved Drug Therapies (852) Sensipar (cinacalcet), Amgen, ...on placebo. Data showed that Sensipar reduced PTH while lowering Ca x P, calcium and phosphorus levels. Secondary efficacy parameters also improved in patients treated with Sensipar. An open-label study ...View Page
14. Newly Approved Drug Therapies (871) Fosrenol, lanthanum carbonate, Shire Pharmaceuticals, ...a 4 week withdrawal period. Results indicated that subjects receiving Fosrenol maintained steady-state serum phosphorus levels, but subjects receiving placebo experienced significant increases in serum phosphate levels (1.9 mg ...View Page
15. CenterWatch: Hematology Approved Drug Therapies ...of hemophilia A, Approved June 2000 Renagel (sevelamer hydrochloride) ; Genzyme; For the control of serum phosphorus in patients with chronic kidney disease on dialysis, Approved July of 2000 Venofer (iron sucrose ...View Page
16. CenterWatch: List of Newly Approved Drug Thearapies ...chronic renal failure, Approved November 2007 Renvela (sevelamer carbonate) ; Genzyme; For the control of serum phosphorus in patients with chronic kidney disease on dialysis, Approved October 2007 Torisel (temsirolimus) ; Wyeth; For ...View Page
17. CenterWatch Clinical Research Profile (2434) Trial #1178, Northwest Louisiana Nephrology, Shreveport, LA ...Prospective Community Cohort Observational Study to Examine the Prevalence of Abnormalities of Parathyroid Hormone, Calcium, Phosphorus and Vitamins in Patients with Chronic Kidney Disease Phase IV Abbott SEEK Abbott Laboratories, Inc ...View Page
18. Clinical Trial Results by Drug Names ...low concentrations of total protein, albumin, and calcium; high and low concentrations of chloride and phosphorus; high triglyceride levels; high T4 levels; and high and low T3 uptake. Four patients had ...View Page
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