Changes in fibroblast growth factor 23 levels in normophosphatemic patients with chronic kidney disease stage 3 treated with lanthanum carbonate: Results of the PREFECT study, a phase 2a, double blind, randomized, placebo-controlled trial

BMC Nephrology

Volumn 15, Issue 1, 2014, Pages

  Ureña Torres, Pablo ^a   Prié, Dominique ^b   Keddad, Karim ^c   Preston, Peter ^d   Wilde, Paul ^e   Wan, Hong ^d   Copley, J Brian ^d  

^a Centre Ophthalmologique Clinique du Landy   (France)

^b HÔPITAL NECKER ENFANTS MALADES   (France)

^c Shire   (France)

^d SHIRE   (United States)

^e Shire Pharmaceuticals   (United Kingdom)

Author keywords

CKD MBD; FGF23; Lanthanum carbonate; Parathyroid hormone; Phosphate binders; Phosphaturia

Indexed keywords

CALCITRIOL; CALCIUM; FIBROBLAST GROWTH FACTOR 23; LANTHANUM CARBONATE; PARATHYROID HORMONE; PHOSPHATE; PLACEBO; BIOLOGICAL MARKER; FIBROBLAST GROWTH FACTOR; LANTHANUM; PHOSPHORUS;

ABDOMINAL DISCOMFORT; ACUTE PANCREATITIS; ADULT; AGED; ANOREXIA; ARTICLE; BRONCHITIS; CALCIUM URINE LEVEL; CARBOXY TERMINAL SEQUENCE; CHRONIC KIDNEY DISEASE; CLINICAL ARTICLE; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG INDUCED HEADACHE; ERYTHEMA; FEMALE; HEART FAILURE; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HORMONE URINE LEVEL; HUMAN; HYPERHIDROSIS; HYPERTENSION; INTESTINE ABSORPTION; MALE; PHASE 2 CLINICAL TRIAL; PHOSPHATE URINE LEVEL; PHOSPHATURIA; POLYURIA; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TREATMENT DURATION; TREATMENT OUTCOME; URINE LEVEL; VERY ELDERLY; VOMITING; XEROSTOMIA; BLOOD; CLINICAL TRIAL; MIDDLE AGED; PLACEBO EFFECT; REFERENCE VALUE; RENAL INSUFFICIENCY, CHRONIC;

ADULT; AGED; AGED, 80 AND OVER; BIOLOGICAL MARKERS; DOUBLE-BLIND METHOD; FEMALE; FIBROBLAST GROWTH FACTORS; HUMANS; LANTHANUM; MALE; MIDDLE AGED; PHOSPHORUS; PLACEBO EFFECT; REFERENCE VALUES; RENAL INSUFFICIENCY, CHRONIC; TREATMENT OUTCOME;

EID: 84900859557     PISSN: None     EISSN: 14712369     Source Type: Journal    
DOI: 10.1186/1471-2369-15-71     Document Type: Article

References (32)

1. "Phosphatonins" and the regulation of phosphorus homeostasis. Berndt TJ, Schiavi S, Kumar R, Am J Physiol Renal Physiol 2005 289 1170 F1182 10.1152/ajprenal.00072.2005 16275744 (Pubitemid 41681350)
2. Fibroblast growth factor 23 (FGF23) predicts progression of chronic kidney disease: the Mild to Moderate Kidney Disease (MMKD) Study. Fliser D, Kollerits B, Neyer U, Ankerst DP, Lhotta K, Lingenhel A, Ritz E, Kronenberg F, Kuen E, Konig P, Kraatz G, Mann JF, Muller GA, Kohler H, Riegler P, J Am Soc Nephrol 2007 18 2600 2608 10.1681/ASN.2006080936 17656479 (Pubitemid 47378877)
3. Role of fibroblast growth factor-23 in peripheral vascular calcification in non-diabetic and diabetic hemodialysis patients. Inaba M, Okuno S, Imanishi Y, Yamada S, Shioi A, Yamakawa T, Ishimura E, Nishizawa Y, Osteoporos Int 2006 17 1506 1513 10.1007/s00198-006-0154-6 16896512 (Pubitemid 44387485)
4. Fibroblast growth factor 23 and left ventricular hypertrophy in chronic kidney disease. Gutierrez OM, Januzzi JL, Isakova T, Laliberte K, Smith K, Collerone G, Sarwar A, Hoffmann U, Coglianese E, Christenson R, Wang TJ, DeFilippi C, Wolf M, Circulation 2009 119 2545 2552 10.1161/CIRCULATIONAHA.108. 844506 19414634
5. Fibroblast growth factor 23, cardiovascular disease risk factors, and phosphorus intake in the health professionals follow-up study. Gutierrez OM, Wolf M, Taylor EN, Clin J Am Soc Nephrol 2011 6 2871 2878 10.2215/CJN.02740311 22034506
6. FGF-23 associates with death, cardiovascular events, and initiation of chronic dialysis. Kendrick J, Cheung AK, Kaufman JS, Greene T, Roberts WL, Smits G, Chonchol M, J Am Soc Nephrol 2011 22 1913 1922 10.1681/ASN.2010121224 21903574
7. Serum fibroblast growth factor-23 (FGF-23) levels are independently associated with left ventricular mass and myocardial performance index in maintenance haemodialysis patients. Kirkpantur A, Balci M, Gurbuz OA, Afsar B, Canbakan B, Akdemir R, Ayli MD, Nephrol Dial Transplant 2011 26 1346 1354 10.1093/ndt/gfq539 20813767
8. Fibroblast growth factor-23 and death, heart failure, and cardiovascular events in community-living individuals: CHS (Cardiovascular Health Study). Ix JH, Katz R, Kestenbaum BR, de Boer IH, Chonchol M, Mukamal KJ, Rifkin D, Siscovick DS, Sarnak MJ, Shlipak MG, J Am Coll Cardiol 2012 60 200 207 10.1016/j.jacc.2012.03.040 22703926
9. Fibroblast growth factor 23 and matrix-metalloproteinases in patients with chronic kidney disease: are they associated with cardiovascular disease? Peiskerova M, Kalousova M, Kratochvilova M, Dusilova-Sulkova S, Uhrova J, Bandur S, Malbohan IM, Zima T, Tesar V, Kidney Blood Press Res 2009 32 276 283 10.1159/000243050 19797911
10. Fibroblast growth factor 23 and mortality among patients undergoing hemodialysis. Gutiérrez O, Mannstadt M, Isakova T, Rauh-Hain J, Tamez H, Shah A, Smith K, Lee H, Thadhani R, Jüppner H, Wolf M, N Engl J Med 2008 359 584 592 10.1056/NEJMoa0706130 18687639
11. Fibroblast growth factor 23 and risks of mortality and end-stage renal disease in patients with chronic kidney disease. Isakova T, Xie H, Yang W, Xie D, Anderson AH, Scialla J, Wahl P, Gutierrez OM, Steigerwalt S, He J, Schwartz S, Lo J, Ojo A, Sondheimer J, Hsu CY, Lash J, Leonard M, Kusek JW, Feldman HI, Wolf M, JAMA 2011 305 2432 2439 10.1001/jama.2011.826 21673295
12. Serum FGF23 and risk of cardiovascular events in relation to mineral metabolism and cardiovascular pathology. Arnlov J, Carlsson AC, Sundstrom J, Ingelsson E, Larsson A, Lind L, Larsson TE, Clin J Am Soc Nephrol 2013 8 781 786 10.2215/CJN.09570912 23335040
13. FGF23 induces left ventricular hypertrophy. Faul C, Amaral AP, Oskouei B, Hu MC, Sloan A, Isakova T, Gutierrez OM, Aguillon-Prada R, Lincoln J, Hare JM, Mundel P, Morales A, Scialla J, Fischer M, Soliman EZ, Chen J, Go AS, Rosas SE, Nessel L, Townsend RR, Feldman HI, St John Sutton M, Ojo A, Gadegbeku C, Di Marco GS, Reuter S, Kentrup D, Tiemann K, Brand M, Hill JA, et al. J Clin Invest 2011 121 4393 4408 10.1172/JCI46122 21985788
14. Fibroblast growth factor 23: uremic toxin or innocent bystander in chronic kidney disease? Stubbs JR, Quarles LD, Nephrol News Issues 2009 23 33 34 36-37 19534362
15. Fibroblast growth factor-23 mitigates hyperphosphatemia but accentuates calcitriol deficiency in chronic kidney disease. Gutierrez O, Isakova T, Rhee E, Shah A, Holmes J, Collerone G, Juppner H, Wolf M, J Am Soc Nephrol 2005 16 2205 2215 10.1681/ASN.2005010052 15917335 (Pubitemid 41716454)
16. Fibroblast growth factor-23 relationship to dietary phosphate and renal phosphate handling in healthy young men. Ferrari SL, Bonjour JP, Rizzoli R, J Clin Endocrinol Metab 2005 90 1519 1524 10.1210/jc.2004-1039 15613425 (Pubitemid 40464013)
17. Effects of a high-protein diet on regulation of phosphorus homeostasis. Kremsdorf RA, Hoofnagle AN, Kratz M, Weigle DS, Callahan HS, Purnell JQ, Horgan AM, de Boer IH, Kestenbaum BR, J Clin Endocrinol Metab 2013 98 1207 1213 10.1210/jc.2012-2910 23393178
18. Early control of PTH and FGF23 in normophosphatemic CKD patients: a new target in CKD-MBD therapy? Oliveira RB, Cancela AL, Graciolli FG, Dos Reis LM, Draibe SA, Cuppari L, Carvalho AB, Jorgetti V, Canziani ME, Moyses RM, Clin J Am Soc Nephrol 2010 5 286 291 10.2215/CJN.05420709 19965540
19. Lanthanum carbonate reduces FGF23 in chronic kidney disease stage 3 patients. Gonzalez-Parra E, Gonzalez-Casaus ML, Galan A, Martinez-Calero A, Navas V, Rodriguez M, Ortiz A, Nephrol Dial Transplant 2011 26 2567 2571 10.1093/ndt/gfr144 21436379
20. Effects of dietary phosphate restriction and phosphate binders on FGF23 Levels in CKD. Isakova T, Barchi-Chung A, Enfield G, Smith K, Vargas G, Houston J, Xie H, Wahl P, Schiavenato E, Dosch A, Gutierrez OM, Diego J, Lenz O, Contreras G, Mendez A, Weiner RB, Wolf M, Clin J Am Soc Nephrol 2013 8 1009 1018 10.2215/CJN.09250912 23471131
21. Acute effects of very-low-protein diet on FGF23 levels: a randomized study. Di Iorio B, Di Micco L, Torraca S, Sirico ML, Russo L, Pota A, Mirenghi F, Russo D, Clin J Am Soc Nephrol 2012 7 581 587 10.2215/CJN.07640711 22362063
22. Is controlling phosphorus by decreasing dietary protein intake beneficial or harmful in persons with chronic kidney disease? Shinaberger CS, Greenland S, Kopple JD, Van Wyck D, Mehrotra R, Kovesdy CP, Kalantar-Zadeh K, Am J Clin Nutr 2008 88 1511 1518 10.3945/ajcn.2008.26665 19064510
23. Nicotinamide suppresses hyperphosphatemia in hemodialysis patients. Takahashi Y, Tanaka A, Nakamura T, Fukuwatari T, Shibata K, Shimada N, Ebihara I, Koide H, Kidney Int 2004 65 1099 1104 10.1111/j.1523-1755.2004.00482.x 14871431 (Pubitemid 38251086)
24. Pilot study of dietary phosphorus restriction and phosphorus binders to target fibroblast growth factor 23 in patients with chronic kidney disease. Isakova T, Gutierrez OM, Smith K, Epstein M, Keating LK, Juppner H, Wolf M, Nephrol Dial Transplant 2011 26 584 591 10.1093/ndt/gfq419 20631407
25. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D, Ann Intern Med 1999 130 461 470 10.7326/0003-4819-130-6-199903160-00002 10075613 (Pubitemid 29135798)
26. ICH harmonised tripartite guidelines for good clinical practice. 1996 http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/ E6-R1/Step4/E6-R1-Guideline.pdf
27. Declaration of Helsinki: ethical principles for medical research involving human subjects. http://www.wma.net/en/30publications/10policies/b3/ index.html.pdf?print-media-type&footer-right=%5Bpage%5D/%5BtoPage%5D
28. A simple method for the determination of glomerular filtration rate. Brochner-Mortensen J, Scand J Clin Lab Invest 1972 30 271 274 10.3109/00365517209084290 4629674
29. Forging forward with 10 burning questions on FGF23 in kidney disease. Wolf M, J Am Soc Nephrol 2010 21 1427 1435 10.1681/ASN.2009121293 20507943
30. Fibroblast growth factor 23 in oncogenic osteomalacia and X-linked hypophosphatemia. Jonsson KB, Zahradnik R, Larsson T, White KE, Sugimoto T, Imanishi Y, Yamamoto T, Hampson G, Koshiyama H, Ljunggren O, Oba K, Yang IM, Miyauchi A, Econs MJ, Lavigne J, Juppner H, N Engl J Med 2003 348 1656 1663 10.1056/NEJMoa020881 12711740 (Pubitemid 36459471)
31. Effects of phosphate binders in moderate CKD. Block GA, Wheeler DC, Persky MS, Kestenbaum B, Ketteler M, Spiegel DM, Allison MA, Asplin J, Smits G, Hoofnagle AN, Kooienga L, Thadhani R, Mannstadt M, Wolf M, Chertow GM, J Am Soc Nephrol 2012 23 1407 1415 10.1681/ASN.2012030223 22822075
32. Comparison of calcium acetate and sevelamer on vascular function and fibroblast growth factor 23 in CKD patients: a randomized clinical trial. Yilmaz MI, Sonmez A, Saglam M, Yaman H, Kilic S, Eyileten T, Caglar K, Oguz Y, Vural A, Yenicesu M, Mallamaci F, Zoccali C, Am J Kidney Dis 2012 59 177 185 10.1053/j.ajkd.2011.11.007 22137672