A 12-Week, Double-Blind, Placebo-Controlled Trial of Ferric Citrate for the Treatment of Iron Deficiency Anemia and Reduction of Serum Phosphate in Patients with CKD Stages 3-5

American Journal of Kidney Diseases

Volumn 65, Issue 5, 2015, Pages 728-736

  Block, Geoffrey A ^a   Fishbane, Steven ^b   Rodriguez, Mariano ^c   Smits, Gerard ^a   Shemesh, Shay ^d   Pergola, Pablo E ^e   Wolf, Myles ^f   Chertow, Glenn M ^g  

^a Denver Nephrologists PC   (United States)

^b DONALD AND BARBARA ZUCKER SCHOOL OF MEDICINE AT HOFSTRA NORTHWELL   (United States)

^c Hospital Universitario Reina Sofia   (Spain)

^d AKEBIA THERAPEUTICS   (United States)

^e Renal Associates PA   (United States)

^f NORTHWESTERN UNIVERSITY   (United States)

^g STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Chronic kidney disease (CKD); ferric citrate coordination complex (ferric citrate); fibroblast growth factor 23 (FGF 23); hemoglobin; iron repletion; iron deficiency anemia; oral iron therapy; phosphate binder; randomized controlled trial; serum phosphate; transferrin saturation (TSAT); urinary phosphate excretion

Indexed keywords

FERRIC CITRATE; FERRITIN; FIBROBLAST GROWTH FACTOR 23; HEMOGLOBIN; PHOSPHATE; TRANSFERRIN; ANTIANEMIC AGENT; FERRIC ION; FIBROBLAST GROWTH FACTOR;

ABNORMAL FECES; ADULT; AGED; ARTICLE; CHRONIC KIDNEY DISEASE; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FEMALE; FERRITIN BLOOD LEVEL; GLOMERULUS FILTRATION RATE; HEMOGLOBIN BLOOD LEVEL; HUMAN; IRON DEFICIENCY ANEMIA; IRON STORAGE; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; PHOSPHATE BLOOD LEVEL; PHOSPHATE EXCRETION; PHOSPHATE URINE LEVEL; RANDOMIZED CONTROLLED TRIAL; ANEMIA, IRON-DEFICIENCY; BLOOD; CHRONIC KIDNEY FAILURE; DISEASE COURSE; URINE;

AGED; ANEMIA, IRON-DEFICIENCY; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; FEMALE; FERRIC COMPOUNDS; FIBROBLAST GROWTH FACTORS; HEMATINICS; HUMANS; MALE; MIDDLE AGED; PHOSPHATES; RENAL INSUFFICIENCY, CHRONIC;

EID: 84926493841     PISSN: 02726386     EISSN: 15236838     Source Type: Journal    
DOI: 10.1053/j.ajkd.2014.10.014     Document Type: Article

References (46)

1. A.J. Collins, R.N. Foley, B. Chavers, et al. Introduction to volume one: US Renal Data System 2013 annual data report Am J Kidney Dis 63 1 suppl 1 2014 e1 e22
2. C.P. Kovesdy, B.K. Trivedi, K. Kalantar-Zadeh, and J.E. Anderson Association of anemia with outcomes in men with moderate and severe chronic kidney disease Kidney Int 69 3 2006 560 564
3. S. Fishbane, S. Pollack, H.I. Feldman, and M.M. Joffe Iron indices in chronic kidney disease in the National Health and Nutritional Examination Survey 1988-2004 Clin J Am Soc Nephrol 4 2009 57 61
4. T.B. Drueke, and P.S. Parfrey Summary of the KDIGO guideline on anemia and comment: reading between the (guide)line(s) Kidney Int 82 9 2012 952 960
5. M.J. Cancelo-Hidalgo, C. Castelo-Branco, S. Palacios, et al. Tolerability of different oral iron supplements: a systematic review Curr Med Res Opin 29 4 2013 291 303
6. I.C. Macdougall, W.E. Strauss, J. McLaughlin, Z. Li, F. Dellanna, and J. Hertel A randomized comparison of ferumoxytol and iron sucrose for treating iron deficiency anemia in patients with CKD Clin J Am Soc Nephrol 9 4 2014 705 712
7. C.M. O'Seaghdha, S.J. Hwang, P. Muntner, M.L. Melamed, and C.S. Fox Serum phosphorus predicts incident chronic kidney disease and end-stage renal disease Nephrol Dial Transplant 26 9 2011 2885 2890
8. C. Zoccali, P. Ruggenenti, A. Perna, et al. Phosphate may promote CKD progression and attenuate renoprotective effect of ACE inhibition J Am Soc Nephrol 22 10 2011 1923 1930
9. A. Bellasi, M. Mandreoli, L. Baldrati, et al. Chronic kidney disease progression and outcome according to serum phosphorus in mild-to-moderate kidney dysfunction Clin J Am Soc Nephrol 6 2011 883 891
10. J.J. Scialla, W.L. Lau, M.P. Reilly, et al. Fibroblast growth factor 23 is not associated with and does not induce arterial calcification Kidney Int 83 6 2013 1159 1168
11. H. Eddington, R. Hoefield, S. Sinha, et al. Serum phosphate and mortality in patients with chronic kidney disease Clin J Am Soc Nephrol 5 12 2010 2251 2257
12. B. Kestenbaum, J.N. Sampson, K.D. Rudser, et al. Serum phosphate levels and mortality risk among people with chronic kidney disease J Am Soc Nephrol 16 2 2005 520 528
13. R. Dhingra, L.M. Sullivan, C.S. Fox, et al. Relations of serum phosphorus and calcium levels to the incidence of cardiovascular disease in the community Arch Intern Med 167 9 2007 879 885
14. T. Isakova, P. Wahl, G.S. Vargas, et al. Fibroblast growth factor 23 is elevated before parathyroid hormone and phosphate in chronic kidney disease Kidney Int 79 12 2011 1370 1378
15. M. Kuro-o Klotho in health and disease Curr Opin Nephrol Hypertens 21 4 2012 362 368
16. C. Faul, A.P. Amaral, B. Oskouei, et al. FGF23 induces left ventricular hypertrophy J Clin Invest 121 11 2011 4393 4408
17. J. Kendrick, A.K. Cheung, J.S. Kaufman, et al. FGF-23 associates with death, cardiovascular events, and initiation of chronic dialysis J Am Soc Nephrol 22 10 2011 1913 1922
18. J.J. Scialla, H. Xie, M. Rahman, et al. Fibroblast growth factor-23 and cardiovascular events in CKD J Am Soc Nephrol 25 2 2014 349 360
19. G.A. Block, D.C. Wheeler, M.S. Persky, et al. Effects of phosphate binders in moderate CKD J Am Soc Nephrol 23 8 2012 1407 1415
20. B. Newsome, J.H. Ix, H. Tighiouart, et al. Effect of protein restriction on serum and urine phosphate in the Modification of Diet in Renal Disease (MDRD) Study Am J Kidney Dis 61 6 2013 1045 1046
21. C.T. Lee, I.W. Wu, and S.S. Chiang Effect of oral ferric citrate on serum phosphorus in hemodialysis patients: multicenter, randomized, double-blind, placebo-controlled study [published online ahead of print May 20, 2014] J Nephrol 2014 http://dx.doi.org/10.1007/s40620-014-0108-6
22. Lewis JB, Sika M, Koury MJ, et al. for the Collaborative Study Group. Ferric citrate controls phosphorus and delivers iron in patients on dialysis [published online ahead of print July 24, 2014]. J Am Soc Nephrol. http://dx.doi.org/10.1681/ASN.2014020212.
23. K. Yokoyama, T. Akiba, M. Fukagawa, et al. A randomized trial of JTT-751 versus sevelamer hydrochloride in patients on hemodialysis Nephrol Dial Transplant 29 5 2014 1053 1060
24. K. Yokoyama, T. Akiba, M. Fukagawa, et al. Long-term safety and efficacy of a novel iron-containing phosphate binder, JTT-751, in patients receiving hemodialysis J Ren Nutr 24 4 2014 261 267
25. K. Yokoyama, H. Hirakata, T. Akiba, K. Sawada, and Y. Kumagai Effect of oral JTT-751 (ferric citrate) on hyperphosphatemia in hemodialysis patients: results of a randomized, double-blind, placebo-controlled trial Am J Nephrol 36 5 2012 478 487
26. O. Siddiqui, H.M. Hung, and R. O'Neill MMRM vs. LOCF: a comprehensive comparison based on simulation study and 25 NDA datasets J Biopharm Stat 19 2 2009 227 246
27. R. Agarwal, A.R. Rizkala, B. Bastani, M.O. Kaskas, D.J. Leehey, and A. Besarab A randomized controlled trial of oral versus intravenous iron in chronic kidney disease Am J Nephrol 26 5 2006 445 454
28. B.S. Spinowitz Ferumoxytol for treating iron deficiency anemia in CKD J Am Soc Nephrol 19 8 2008 1599 1605
29. S. Tagboto The efficacy of a single dose of intravenous ferric carboxymaltose on anaemia in a pre-dialysis population of chronic kidney disase patients J Ren Care 35 1 2009 18 23
30. N.D. Vaziri Understanding iron: promoting its safe use in patients with chronic kidney failure treated by hemodialysis Am J Kidney Dis 61 6 2013 992 1000
31. M.A. Brookhart, J.K. Freburger, A.R. Ellis, L. Wang, W.C. Winkelmayer, and A.V. Kshirsagar Infection risk with bolus versus maintenance iron supplementation in hemodialysis patients J Am Soc Nephrol 24 7 2013 1151 1158
32. M.A. Pfeffer, E.A. Burdmann, C.Y. Chen, et al. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease N Engl J Med 361 21 2009 2019 2032
33. S.D. Anker, C. Colet, and G. Fillipatos Ferric carboxymaltose in patients with heart failure and iron deficiency N Engl J Med 361 2009 2436 2448
34. C. Bergwitz, and H. Juppner Regulation of phosphate homeostasis by PTH, vitamin D, and FGF23 Annu Rev Med 61 2010 91 104
35. T. Isakova, H. Xie, W. Yang, et al. Fibroblast growth factor 23 and risks of mortality and end-stage renal disease in patients with chronic kidney disease JAMA 305 23 2011 2432 2439
36. O.M. Gutierrez Fibroblast growth factor 23 and disordered vitamin D metabolism in chronic kidney disease: updating the "trade-off" hypothesis Clin J Am Soc Nephrol 5 9 2010 1710 1716
37. O.M. Gutierrez, J.L. Januzzi, T. Isakova, et al. Fibroblast growth factor 23 and left ventricular hypertrophy in chronic kidney disease Circulation 119 19 2009 2545 2552
38. G.A. Block, J.H. Ix, M. Ketteler, et al. Phosphate homeostasis in CKD: report of a scientific symposium sponsored by the National Kidney Foundation Am J Kidney Dis 62 3 2013 457 473
39. J.H. Ix, R. Katz, B.R. Kestenbaum, et al. Fibroblast growth factor-23 and death, heart failure, and cardiovascular events in community-living individuals: CHS (Cardiovascular Health Study) J Am Coll Cardiol 60 3 2012 200 207
40. J.R. Dominguez, B. Kestenbaum, M. Chonchol, et al. Relationships between serum and urine phosphorus with all-cause and cardiovascular mortality: the Osteoporotic Fractures in Men (MrOS) Study Am J Kidney Dis 61 4 2013 555 563
41. M. Wolf, T.A. Koch, and D.B. Bregman Effects of iron deficiency anemia and its treatment on fibroblast growth factor 23 and phosphate homeostasis in women J Bone Miner Res 28 8 2013 1793 1803
42. K.T. Yamamoto, C. Robinson-Cohen, M.C. de Oliveira, et al. Dietary phosphorus is associated with greater left ventricular mass Kidney Int 83 4 2013 707 714
43. A.R. Chang, M. Lazo, L.J. Appel, O.M. Gutierrez, and M.E. Grams High dietary phosphorus intake is associated with all-cause mortality: results from NHANES III Am J Clin Nutr 99 2 2014 320 327
44. M.S. Calvo, and J. Uribarri Public health impact of dietary phosphorus excess on bone and cardiovascular health in the general population Am J Clin Nutr 98 1 2013 6 15
45. R. Mehrotra, C.A. Peralta, S.-C. Chen, et al. No independent association of serum phosphorus with risk for death or progression to end-stage renal disease in a large screen for chronic kidney disease Kidney Int 84 2013 989 997
46. J.J. Sim, S.K. Bhandari, N. Smith, et al. Phosphorus and risk of renal failure in subjects with normal renal function Am J Med 126 4 2013 311 318