Effects of nicotinamide and lanthanum carbonate on serum phosphate and fibroblast growth factor-23 in CKD: The COMBINE trial

Journal of the American Society of Nephrology

Volumn 30, Issue 6, 2019, Pages 1096-1108

  Ix, Joachim H ^a,b,c   Isakova, Tamara ^d   Larive, Brett ^e   Raphael, Kalani L ^f   Raj, Dominic S ^g   Cheung, Alfred K ^f   Sprague, Stuart M ^h   Fried, Linda F ^i,j   Gassman, Jennifer J ^e   Middleton, John P ^k,l   Flessner, Michael F ^m   Block, Geoffrey A ⁿ   Wolf, Myles ^k,l  

^a UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c VA SAN DIEGO HEALTHCARE SYSTEM   (United States)

^d NORTHWESTERN UNIVERSITY   (United States)

^e LERNER RESEARCH INSTITUTE   (United States)

^f UNIVERSITY OF UTAH   (United States)

^g GEORGE WASHINGTON UNIVERSITY   (United States)

^h NORTHSHORE UNIVERSITY HEALTHSYSTEM   (United States)

ⁱ UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH   (United States)

^j UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^k DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^l DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^m NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES   (United States)

ⁿ Denver Nephrology   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

FIBROBLAST GROWTH FACTOR; FIBROBLAST GROWTH FACTOR 23; LANTHANUM; LANTHANUM CARBONATE; NICOTINAMIDE; PHOSPHATE; PLACEBO;

ADULT; BLOOD; CHRONIC KIDNEY FAILURE; CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; FEMALE; GLOMERULUS FILTRATION RATE; HUMAN; MALE; MIDDLE AGED; MONTE CARLO METHOD; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; ADVERSE EVENT; AGED; ARTICLE; BLEEDING; DIARRHEA; DRUG SAFETY; DRUG TOLERABILITY; ESTIMATED GLOMERULAR FILTRATION RATE; FLUSHING; HEARTBURN; KIDNEY FUNCTION; MAJOR CLINICAL STUDY; MINERAL METABOLISM; NAUSEA; PARALLEL DESIGN; PHOSPHATE BLOOD LEVEL; PRIORITY JOURNAL; SKIN BRUISING; UNITED STATES; URTICARIA;

ADULT; DOUBLE-BLIND METHOD; FEMALE; FIBROBLAST GROWTH FACTORS; GLOMERULAR FILTRATION RATE; HUMANS; LANTHANUM; MALE; MIDDLE AGED; MONTE CARLO METHOD; NIACINAMIDE; PHOSPHATES; RENAL INSUFFICIENCY, CHRONIC; RISK ASSESSMENT; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 85066968906     PISSN: 10466673     EISSN: 15333450     Source Type: Journal    
DOI: 10.1681/ASN.2018101058     Document Type: Article

References (34)

1. Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY: Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med 351: 1296–1305, 2004
2. Ix JH, Katz R, Kestenbaum BR, de Boer IH, Chonchol M, Mukamal KJ, et al.: Fibroblast growth factor-23 and death, heart failure, and cardiovascular events in community-living individuals: CHS (Cardiovas-cular Health Study). J Am Coll Cardiol 60: 200–207, 2012
3. Dominguez JR, Kestenbaum B, Chonchol M, Block G, Laughlin GA, Lewis CE, et al.: Osteoporotic Fractures in Men (MrOS) Study Research Group: Relationships between serum and urine phosphorus with all-cause and cardiovascular mortality: The Osteoporotic Fractures in Men (MrOS) Study. Am J Kidney Dis 61: 555–563, 2013
4. Foley RN, Collins AJ, Herzog CA, Ishani A, Kalra PA: Serum phosphorus levels associate with coronary atherosclerosis in young adults. J AmSoc Nephrol 20: 397–404, 2009
5. Burnett SM, Gunawardene SC, Bringhurst FR, Jüppner H, Lee H, Finkelstein JS: Regulation of C-terminal and intact FGF-23 by dietary phosphate in men and women. J Bone Miner Res 21: 1187–1196, 2006
6. Faul C, Amaral AP, Oskouei B, Hu M-C, Sloan A, Isakova T, et al.: FGF23 induces left ventricular hypertrophy. J Clin Invest 121: 4393–4408, 2011
7. Block GA, Wheeler DC, Persky MS, Kestenbaum B, Ketteler M, Spiegel DM, et al.: Effects of phosphate binders in moderate CKD. J Am Soc Nephrol 23: 1407–1415, 2012
8. Schiavi SC, Tang W, Bracken C, O’Brien SP, Song W, Boulanger J, et al.: Npt2b deletion attenuates hyperphosphatemia associated with CKD. J Am Soc Nephrol 23: 1691–1700, 2012
9. Isakova T, Ix JH, Sprague SM, Raphael KL, Fried L, Gassman JJ, et al.: Rationale and approaches to phosphate and fibroblast growth factor 23 reduction in CKD. J Am Soc Nephrol 26: 2328–2339, 2015
10. Ginsberg C, Ix JH: Nicotinamide and phosphate homeostasis in chronic kidney disease. Curr Opin Nephrol Hypertens 25: 285–291, 2016
11. Takahashi Y, Tanaka A, Nakamura T, Fukuwatari T, Shibata K, Shimada N, et al.: Nicotinamide suppresses hyperphosphatemia in hemodialysis patients. Kidney Int 65: 1099–1104, 2004
12. Cheng SC, Young DO, Huang Y, Delmez JA, Coyne DW: A randomized, double-blind, placebo-controlled trial of niacinamide for reduction of phosphorus in hemodialysis patients. Clin J Am Soc Nephrol 3: 1131–1138, 2008
13. Young DO, Cheng SC, Delmez JA, Coyne DW: The effect of oral niacinamide on plasma phosphorus levels in peritoneal dialysis patients. Perit Dial Int 29: 562–567, 2009
14. El Borolossy R, El Wakeel LM, El Hakim I, Sabri N: Efficacy and safety of nicotinamide in the management of hyperphosphatemia in pediatric patients on regular hemodialysis. Pediatr Nephrol 31: 289–296, 2016
15. Vasantha J, Soundararajan P, Vanitharani N, Kannan G, Thennarasu P, Neenu G, et al.: Safety and efficacy of nicotinamide in the management of hyperphosphatemia in patients on hemodialysis. Indian J Nephrol 21: 245–249, 2011
16. Shahbazian H, Zafar Mohtashami A, Ghorbani A, Abbaspour MR, Belladi Musavi SS, Hayati F, et al.: Oral nicotinamide reduces serum phosphorus, increases HDL, and induces thrombocytopenia in hemodialysis patients: A double-blind randomized clinical trial. Nefrologia 31: 58–65, 2011
17. Lenglet A, Liabeuf S, El Esper N, Brisset S, Mansour J, Lemaire-Hurtel A-S, et al.: Efficacy and safety of nicotinamide in haemodialysis patients: The NICOREN study. Nephrol Dial Transplant 32: 870–879, 2017
18. Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, et al.: CKD-EPI (Chronic Kidney Disease Epidemiology Collabora-tion): A new equation to estimate glomerular filtration rate. Ann Intern Med 150: 604–612, 2009
19. Ix JH, Anderson CAM, Smits G, Persky MS, Block GA: Effect of dietary phosphate intake on the circadian rhythm of serum phosphate concentrations in chronic kidney disease: A crossover study. Am J Clin Nutr 100: 1392–1397, 2014
20. Gassman JJ, Greene T, Wright JT Jr., Agodoa L, Bakris G, Beck GJ, et al.: Design and statistical aspects of the African American Study of Kidney Disease and Hypertension (AASK). J Am Soc Nephrol 14[Suppl 2]: S154–S165, 2003
21. Ix JH, Chonchol M, Laughlin GA, Shlipak MG, Whooley MA: Relation of sex and estrogen therapy to serum fibroblast growth factor 23, serum phosphorus, and urine phosphorus: The Heart and Soul Study. Am J Kidney Dis 58: 737–745, 2011
22. Ix JH, Ganjoo P, Tipping D, Tershakovec AM, Bostom AG: Sustained hypophosphatemic effect of once-daily niacin/laropiprant in dyslipidemic CKD stage 3 patients. Am J Kidney Dis 57: 963–965, 2011
23. Isakova T, Gutiérrez OM, Smith K, Epstein M, Keating LK, Jüppner H, et al.: Pilot study of dietary phosphorus restriction and phosphorus binders to target fibroblast growth factor 23 in patients with chronic kidney disease. Nephrol Dial Transplant 26: 584–591, 2011
24. Chue CD, Townend JN, Moody WE, Zehnder D, Wall NA, Harper L, et al.: Cardiovascular effects of sevelamer in stage 3 CKD. J Am Soc Nephrol 24: 842–852, 2013
25. Oliveira RB, Cancela ALE, Graciolli FG, Dos Reis LM, Draibe SA, Cuppari L, et al.: Early control of PTH and FGF23 in normophospha-temic CKD patients: A new target in CKD-MBD therapy? Clin J Am Soc Nephrol 5: 286–291, 2010
26. Gonzalez-Parra E, Gonzalez-Casaus ML, Galán A, Martinez-Calero A, Navas V, Rodriguez M, et al.: Lanthanum carbonate reduces FGF23 in chronic kidney disease Stage 3 patients. Nephrol Dial Transplant 26: 2567–2571, 2011
27. Fishbane S, Block GA, Loram L, Neylan J, Pergola PE, Uhlig K, et al.: Effects of ferric citrate in patients with nondialysis-dependent CKD and iron deficiency anemia. J Am Soc Nephrol 28: 1851–1858, 2017
28. Radanovic T, Wagner CA, Murer H, Biber J: Regulation of intestinal phosphate transport. I. Segmental expression and adaptation to low-P(i) diet of the type IIb Na(+)-P(i) cotransporter in mouse small intestine. Am J Physiol Gastrointest Liver Physiol 288: G496– G500, 2005
29. Katai K, Tanaka H, Tatsumi S, Fukunaga Y, Genjida K, Morita K, et al.: Nicotinamide inhibits sodium-dependent phosphate cotransport activity in rat small intestine. Nephrol Dial Transplant 14: 1195–1201, 1999
30. Eto N, Miyata Y, Ohno H, Yamashita T: Nicotinamide prevents the devel opment of hyperphosphataemia by suppressing intestinal sodium-dependent phosphate transporter in rats with adenine-induced renal failure. Nephrol Dial Transplant 20: 1378–1384, 2005
31. Hill KM, Martin BR, Wastney ME, McCabe GP, Moe SM, Weaver CM, et al.: Oral calcium carbonate affects calcium but not phosphorus balance in stage 3-4 chronic kidney disease. Kidney Int 83: 959–966, 2013
32. King A, Siegl M, He Y, Nie B, Wang J, Koo-McCoy S, et al.: Inhibition of sodium/hydrogen exchanger 3 in the gastrointestinal tract by te-napanor reduces paracellular phosphate permeability. Sci Transl Med 10: eaam6474, 2018
33. Farrow EG, Yu X, Summers LJ, Davis SI, Fleet JC, Allen MR, et al.: Iron deficiency drives an autosomal dominant hypophosphatemic rickets (ADHR) phenotype in fibroblast growth factor-23 (Fgf23) knock-in mice. Proc Natl Acad Sci U S A 108: E1146–E1155, 2011
34. David V, Martin A, Isakova T, Spaulding C, Qi L, Ramirez V, et al.: Inflammation and functional iron deficiency regulate fibroblast growth factor 23 production. Kidney Int 89: 135–146, 2016