Research Activity

 
PUBLICATIONS, 2006 - 2009

  • Spinowitz, B.S. and Pratt, R.D.  Epoetin delta is effective for the management of anaemia associated with CKD.  Current Medical Research and Opinions, Vol. 22(2006), pp 2507-2513.
  • Spinowitz, B.S., Coyne, D.W., Lok, C.E. et al. C.E.R.A. Maintains Stable Control of Hemoglobin in Patients with Chronic Kidney Disease on Dialysis When Administered Twice Monthly. Am J. Nephrol 2008;28:280-289
    Malluche, H.H., Claude Monier-Faugere, M., Wang, G., Frazao, J.M., Charytan, C., Coburn, J.W., Coyne, D.W., Kaplan, M.R., Baker, N., McCary, L.C., Turner, S.A., and Goodman, W.G.:  AN ASSESSMENT OF CINACALCET HC1 EFFECTS ON BONE HISTOLOGY IN DIALYSIS PATIENTS WITH SECONDARY HYPERPARATHYROIDISM     Clinical Nephrology 2008 Apr;69(4):269-78.
  • Abu-Alfa, A.K., Sloan, L., Charytan, C., Sekkarie, M., Scarlata, D., Globe, D., and Audhya, P.:   DARBEPOOETIN ALFA FOR IMPROVING AND MAINTAINING HEMOGLOBIN LEVELS AND HEALTH-RELATED   QUALITY   OF   LIFE IN   PATIENTS  WITH   CHRONIC KIDNEY DISEASE NOT RECEIVING DIALYSIS  Curr Med Res Opin. 2008 Apr;24(4):1091-100. Epub 2008 Mar 6.
  • Block, G.A., Zeig, S., Sugihara, J., Chetow, G. M., Chi, E. M., Turner, S.A., Bushinsky, D.A:  COMBINED THERAPY WITH CINACALET AND LOW DOSES OF VITAMIN D STEROLS IN PATIENTS WITH MODERATE TO SEVERE SECONDARY HYPERPARATHYROIDISM  Nephrol Dial Transplant 2008 Jul;23(7):2311-8.   
  • Spinowitz, B.S.:  Anemia Management in Patients on Peritoneal Dialysis:  Efficacy &  Safety Epoetin Delta   Haematologica/THJ, 93/05 (May 2008)
  • Spinowitz, B.S., Kausz, A., Baptista, J., et al.:  Safety  and  Efficacy of  Ferumoxytol  for the  Treatment of Liver Deficiency Anemia in Chronic Kidney Disease Patients (Accepted for  Publication, JASN, 2008)
    Spinowitz, B.S., Germain, M., Benz, R., Wolfson, M., McGowan, T., Tang, K.L.,  Kamin, M.; for the Epoetin Alfa Extended Dosing Study Group:  A Randomized Study Of Extended Dosing Regimens For Initiation Of Epoetin Alfa Treatment Of Chronic Kidney Disease     Clin J Am Soc Nephrol 3:1015-1021, 2008.
  • Spinowitz, B.S., Kausz, A.T., Baptista, J., Noble, S.D., Sothinathan, R., Bernardo, M.V., Brenner, and Pereira, B. J.G.:  Ferumoxytol for Treating Iron Defiency Anemia in CKD  JASN, June 4, 2008.
  • Spinowitz, B.S.:  Anermia Management in Patients on Peritoneal Dialysis:  Efficacy and Safety of Epoetin     Haematologica 2008 May;93(5):761-764, doi: 10.3324/haematol.10985
  • Kessler, M., Martinez-Castelao, A., Slamopoulos, K.C., Villa, G., Spinowitz, B., Dougherty, F.C., Beyer, U.:  C.E.R.A. Once Every Four Weeks in Patients With Chronic Kidney Disease Not On Dialysis: the ARCTOS Extension Study     Submitted for publication, Nephrology Dialysis Transplantation      
  • Charytan, C., Spinowitz, B.S., Rachlin, P.,:  THE SAFETY OF HIGH DOSE, 500 MG OVER FOUR (4) HOURS, IRON SUCROSE THERAPY IN ABULATORY AND HOSPITALIZED CKD PATIENTS  In preparation for submission
  • Fishbane, S., Shapiro, W.B., Corry, D. B., Vicks. S.L., Roppolo, M., Rappaport, K., Ling, X., Goodman, W.G., Turner, S., and Charytan C.:  CINACALCET HC1 AND CONCURRENT LOW-DOSE VITAMIN D IMPROVES TREATMENT OF SECONDARY HYPERPARATHYROIDISM IN DIALYSIS PATIENTS COMPARED WITH VITAMIN D ALONGE:  THE ACHIEVE STUDY RESULTS  Clinical Journal of the
  • American Society of Nephrology, Vo. 3, No. 6, pp 1718-1725, November, 2008.
    Chonchol, M., Locatelli, F., Abboud, H.E., Charytan, C., deFrancisco, A.L., Jolly, S., Kaplan, M., Roger, S.D., Sarkar, S., Albizem, M.B., Mix, T.C., Jubo, Y., Block, G.A.:  A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF CINACALCET HC1 IN PARTICIPANTS WITH CKD NOT RECEIVING DIALYSIS  Am J Kidney Dis. 2009 Feb;53(2):197-207. 


ABSTRACTS 


  • De Alvaro, F., Levin, A., Spinowitz, B.S. et al. C.E.R.A. Provides Improved Care in the Correction of Anemia in CKD Patients not on Dialysis With and Without Diabetes. (Presented at IDF, 2006).
  • Sprague, S., Charytan, C., et al:  A PROSPECTIVE OBSERVATIONAL REGISTRY ASSESSING THE MANAGEMENT AND PROGRESSION OF SECONDARY HPT IN PATIENTS WITH CHRONIC KIDNEY DISEASE (ckd):  METHODS AND OBJECTIVES  National Kidney Foundation 2006 Spring Clinical Meetings, April 19-23, 2006, Chicago, Ill. 
  • Shapiro, W., Martinez, C., Charytan, C., Horowitz, J., Tharpe, D., Droge, J., Ling, X., Belozeroff, V., Block, G., Sprague, S.:  A PROSPECTIVE OBSERVATIONAL REGISTRY ASSESSING THE MANAGEMENT AND PROGRESSION OF SECONDARY HYPERPARATHYROIDISM (hpt) IN PATIENTS WITH CHRONIC KIDNEY DISEASE (CKD):Baseline Data   ASN, San Diego, California, November 14-19, 2006.
  • Charytan, C.:  A COMPARISON OF CINACALCET HC1 AND LOW-DOSE VITAMIN d Vs ESCALATING DOSES OF VITAMIN D ALONE—THE ACHIEVE STUDY  ASN, San Diego, California, November 14-19, 2006.
  • Lu, Msl, Arslanian, J., Kopelman, R., Hammes, M., Liu, C., Cleveland, W., and Charytan, C.:  INTERVENTION ANALYSIS:  ACCESS SURVEILLANCE BY VENOUS ACCESS PRESSURE (VASCALERT, VA) vs FLOW (TRANSONIC, TS)  ANS, San Diego, California, November 14-19, 2006.
  • Fishbane, S., Shapiro, W., Corry, D., Rappaport, K., Vicks, S., Ling, X., Maag, A., Turner, S., Charytan, C:  A COMPARISON OF CINACALCET HC1 AND LOW-DOSE VIATAMIN D vs ESCALATING DOSES OF VITRAMIN D ALONE – THE ACHIEVE STUDY, ASN, San Diego, California, November, 2006.
  • Charytan, C., Lu, Z., Arslanaian, J., Kopelman, R., Hammes, M., Liu, C., Cleveland, W.:  (F-PO1041) INTERVENTION ANALYSIS:  ACCESS SURVEILLANCE BY VENOUS ACCESS PRESSURE (VASCALERT, va) VS. FLOW (TRANSONIC, TS)  ASN, San Diego, California, November 17, 2006.
  • Shapiro, W., Martinez, Charytan, C., Horowitz, J., Tharpe, D., Droge, J., Ling, X., Belozeroff, V., Block, G., Sprague, S, for the Registry Study Group:  (PUB358) A PROSPECTIVE OBSERVATIONAL REGISTRY ASSESSING THE MANAGEMENT AND PROGRESSION OF SECONDARY HYPERPARATHYROIDISM (HPT) IN PATIENTS  WITH CHRONIC KIDNEY DISEASE (ckd):  BASELINE DATA  
  • Spinowitz, B.S., Mann, J.,Mikhail, A. et al. Twice Monthly C.E.R.A. Provides Effective Stable Hemoglobin Maintenance in Dialysis Patients with Diabetes Mellitus. (Submitted to ADA,2007)
    Spinowitz, B.S., Germain,M., Benz, R. et al. Extended Dosing Regimens for Initiation of Epoetin Alfa for
  • Treatment of Anemia of Chronic Disease. (Presented at NKF, April 2007).
    Charytan, C., Corry, D., Roppolo, M., Ling, X., Droge, J., Fishbane, S.:  ASSESSING THE USE OF THE CALCIMIMETIC CINACALCET WITH LOW DOSE VITAMIN VERSUS ESCALATING DOSES OF VITAMIN D ALONE IN THE TREATMENT OF SECONDARY HYPERPARATHYROIDISM (HPT) – THE ACHIEVE STUDY BASELINE DATA    National Kidney Foundation Clinical Meeting, Orlando, Florida, April, 2007.
  • Spinowitz, B.S.,Vera-Lionch, M., Sofrygin, O. et al. Achievement of Target Hemoglobin with Ferumoxytol vs. Oral Iron in Anemic CKD Patients not Receiving Erythropoietin- Stimulating Agents (presented ASN 2007).
  • Fisbhane, S., Vicks, S. Ling, X., Turner, S., and Charytan, C.:  CINCALCET WITH LOW DOSE VITAMIN D PROVIDES IMPORVED CONTROL OF PARATHYROID HORMONE, CALCIUM, AND CALCIUM-PHOSPHORUS PRODUCT IN HEMODIALYSIS PATIENTS WITH SECONDARY HYPERPARATHYROIDISM COMPARED WITH VITAMIN D ALONE  Centtre Convencion Internacional Barcelona (CCIB), June 23, 2007.
  • Shapiro, W., Martinez, C., Charytan, C., Horowitz, J., Tharpe, D., Drage, J., Ling, X., Belozeroff, V., Goodman, W., block, G., and Sprague, S.:  TREATMENT PATTERNS IN PATIENTS PROGRESSING THROUGH LATER-STAGE CHRONIC KIDNEY DISEASE (CKD); BASELINE DATA FROM A PROSPECTIVE OBSERVATIONAL REGISTRY    National Kidney Foundation Clinical Meeting, April, 2008, Dallas, Tx 
  • Malluche, H.H., Monier-Faugere, M.C., Wang, G., Frazao, J.M., Charytan, C., Coburn, D.W., Coyne, M.R., Kaplan, N., Baker, L.C., McCary, S.A. Turner and Goodman, W.G.:  AN ASSESSMENT OF CINACALECET HC1 EFFECTS ON BONE HISTOLOGY IN DIALYSIS PATIENTS WITH SECONDARY HYPERPARATHYROIDISM  Clinical Nephrology, Volume 68, No. 4/2008 (April).
  • Raayasa, S, Spinowitz, B., Charytan, C.: CROHN’S DISEASE AND SECONDARY AMYLOIDOSIS:  A RENAL PERSPECTIVE    Residents and Fellows Day, Lang Research Center, New York Hospital Queens, Flushing, N.Y., May 14, 2008.
  • Bhar, A., Mir, M., Sabayev, V., Charytan C.:  ESRD PATIENTS REQUIRING RRT IN MICU:  OUTCOMES AND SERUM PROGNOSTIC MAREKRS  Residents and Fellows Day, Lang Research Center, New York Hospital Queens, Flushing, N.Y., May 14, 2008.
  • Chang, J.J., Ghith, T., Spinowitz, B.S., Charytan, C.:  SAFETY OF A 500 MG IRON SUCROSE 4-HOUR INFUSION FOR THE CORRECTION OF IRON DEFICIENCY ANEMIA, Residents and Fellows Day, Lang Research Center, New York Hospital Queens, Flushing, N.Y., May 14, 2008.
  • Charytan, C:, Miller, R.T., Lu, J., Kubo, Y., Lopez., Horowitz, J.:   HEALTH RELATED QUALITY OF LIFE (HRQOL) IN DIALYSIS PATIETNS TREATED FOR SECONDARY HYPERPARATHYROIDISM (SHPT).  American Society of Nephrology Annual Meeting, Philadelphia, PA., November, 2008.
  • Fishbane, S., Wetmore, J., Moustafa, M., Martinez, C., Stewart, T., Ling, X., Goodman, W., Charytan, C.:  EFFICACY OF TREATMENTS TARGETING THE CALCIUM-SENSING RECEPTOR (CaR) AND VITAMIN D RECEPTOR (VDR) IN CONTROLLING PARATHYROID HORMONE (PTH) IN HEMODIALYSIS PATIENTS  Am Dietetic Assoc Meeting, October, 2008.
  • Levin, N.W., Schmidt, R., Spinowitz, B.S., et al:  C.E.R.A. Has Similar Safety and   Tolerability as Epoetin or Darbepoetin During Hemoglobin Maintenance in Dialysis Patients :  Pooled  Data from 4 Phase III Vials  (Submitted to ICA, 2008)
     
  • Charpentier, B., Olivares,J., Beyer, U., and Spinowitz, B.:  C.E.R.A. Maintains Stable  Haemoglobin Levels in dialysis Patients Regardless of Administration Route (IV or SC)  (Presented at EDTA 2008)
    Spinowitz,B, Kausz, AT, Dioguardi, J et al  Ferumoxytol is Safe in all Stages of Chronic Kidney Disease ( presented at NKF 2008)
  • Spinowitz, B.S.:  Hemoglobin Response Following Ferumoxytol AdministrationIn CKD Patients:  Impact Of Baseline Hemoglobin And Iron Parameters  Accepted for presentation, ASN 2008, Philadelphia, PA
  • Spinowitz, B.S., Milich, L., Chang, M., Brenner, L.:  Gastrointestinal Tolerability Of  IV Ferumoxytol And Oral Iron Therapy In Patients With Iron Deficiency in  Anemia  and Chronic Kidney Disease   Submitted to American Society of Hematology,  2008.             


Studies

Dr. Charytan:

  • A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AST-120 for Prevention of Chronic Kidney Disease Progression in Patients with Moderate to Severe Chronic Kidney Disease including Assessment of Quality of Life
     
  • A Randomized, single-Blind, Placebo-Controlled, 4-Week Treatment Study of the Safety and Biologic Activity of Escalating Multiple Oral Doses of FG-4592 in Subjects with Chronic Kidney Disease Not Requiring Dialysis
     
  • A Phase2 Randomized, Double-Blind, Placebo-controlled Study of FG-3019 in Subjects with Type 2 Diabetes Mellitus (DM) and Persistent Proteinuria on Background Angiotensin Converting Enzyme Inhibitor (ACEi) and/or Angiotensin II Receptor Blocker (ARB) Therapy


Dr. Spinowitz:

  • A 52-Week, Multi-Centered, Double-Blind, Randomized, Placebo-Controlled Phase IIb Trail to Determine the Effects of Bardoxolone Methyl (RTA 402) on eGFR in Patients with Type 2 Diabetes and Chronic Kidney Disease with an eGFR of 2- 45 mL/min/1.73m2 
  • A 30-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy in Dyslipidemic Subjects with Stage 3 Chronic Kidney Disease


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