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Volumn 21, Issue 3, 2017, Pages 407-416

A phase 1 study of the safety, tolerability, pharmacodynamics, and pharmacokinetics of tenapanor in healthy Japanese volunteers

Author keywords

Chronic kidney disease; NHE3 protein; Phosphate absorption; Sodium absorption; Sodium, dietary; Tenapanor

Indexed keywords

BICARBONATE; CHLORIDE; CREATININE; PHOSPHORUS; SODIUM; TENAPANOR; GASTROINTESTINAL AGENT; ISOQUINOLINE DERIVATIVE; SLC9A3 PROTEIN, HUMAN; SODIUM PROTON EXCHANGE PROTEIN 3; SULFONAMIDE;

EID: 84976500756     PISSN: 13421751     EISSN: 14377799     Source Type: Journal    
DOI: 10.1007/s10157-016-1302-8     Document Type: Article
Times cited : (44)

References (33)
  • 2
    • 59849104969 scopus 로고    scopus 로고
    • + exchanger 3 (NHE3) activity in NHE regulatory factor 1 (NHERF1) adaptor protein-deficient mice
    • COI: 1:CAS:528:DC%2BD1MXhsFOnsbk%3D, PID: 18758809
    • + exchanger 3 (NHE3) activity in NHE regulatory factor 1 (NHERF1) adaptor protein-deficient mice. Pflugers Arch. 2009;457:1079–91.
    • (2009) Pflugers Arch , vol.457 , pp. 1079-1091
    • Broere, N.1    Chen, M.2    Cinar, A.3    Singh, A.K.4    Hillesheim, J.5    Riederer, B.6
  • 3
    • 0026806528 scopus 로고
    • Molecular cloning of putative members of the Na/H exchanger gene family. cDNA cloning, deduced amino acid sequence, and mRNA tissue expression of the rat Na/H exchanger NHE-1 and two structurally related proteins
    • COI: 1:CAS:528:DyaK3sXitVOrs7w%3D, PID: 1577762
    • Orlowski J, Kandasamy RA, Shull GE. Molecular cloning of putative members of the Na/H exchanger gene family. cDNA cloning, deduced amino acid sequence, and mRNA tissue expression of the rat Na/H exchanger NHE-1 and two structurally related proteins. J Biol Chem. 1992;267:9331–9.
    • (1992) J Biol Chem , vol.267 , pp. 9331-9339
    • Orlowski, J.1    Kandasamy, R.A.2    Shull, G.E.3
  • 4
    • 0026793379 scopus 로고
    • Cloning and sequencing of a rabbit cDNA encoding an intestinal and kidney-specific Na+/H+ exchanger isoform (NHE-3)
    • COI: 1:CAS:528:DyaK3sXhvVKjurw%3D, PID: 1374392
    • Tse CM, Brant SR, Walker MS, Pouyssegur J, Donowitz M. Cloning and sequencing of a rabbit cDNA encoding an intestinal and kidney-specific Na+/H+ exchanger isoform (NHE-3). J Biol Chem. 1992;267:9340–6.
    • (1992) J Biol Chem , vol.267 , pp. 9340-9346
    • Tse, C.M.1    Brant, S.R.2    Walker, M.S.3    Pouyssegur, J.4    Donowitz, M.5
  • 6
    • 84929303170 scopus 로고    scopus 로고
    • Gastrointestinal inhibition of sodium-hydrogen exchanger 3 reduces phosphorus absorption and protects against vascular calcification in CKD
    • PID: 25404658
    • Labonté ED, Carreras CW, Leadbetter MR, Kozuka K, Kohler J, Koo-McCoy S, et al. Gastrointestinal inhibition of sodium-hydrogen exchanger 3 reduces phosphorus absorption and protects against vascular calcification in CKD. J Am Soc Nephrol. 2014;26:1138–49.
    • (2014) J Am Soc Nephrol , vol.26 , pp. 1138-1149
    • Labonté, E.D.1    Carreras, C.W.2    Leadbetter, M.R.3    Kozuka, K.4    Kohler, J.5    Koo-McCoy, S.6
  • 7
    • 84942854163 scopus 로고    scopus 로고
    • Tenapanor, a minimally absorbed NHE3 inhibitor, reduces dietary phosphorus absorption in healthy volunteers (presentation FR-OR112)
    • Rosenbaum D, Johansson S, Carlsson B, Spencer AG, Stefánsson B, Knutsson M, et al. Tenapanor, a minimally absorbed NHE3 inhibitor, reduces dietary phosphorus absorption in healthy volunteers (presentation FR-OR112). J Am Soc Nephrol. 2014;25:72A.
    • (2014) J Am Soc Nephrol , vol.25 , pp. 72A
    • Rosenbaum, D.1    Johansson, S.2    Carlsson, B.3    Spencer, A.G.4    Stefánsson, B.5    Knutsson, M.6
  • 8
    • 79953060193 scopus 로고    scopus 로고
    • The importance of population-wide sodium reduction as a means to prevent cardiovascular disease and stroke: a call to action from the American Heart Association
    • PID: 21233236
    • Appel LJ, Frohlich ED, Hall JE, Pearson TA, Sacco RL, Seals DR, et al. The importance of population-wide sodium reduction as a means to prevent cardiovascular disease and stroke: a call to action from the American Heart Association. Circulation. 2011;123:1138–43.
    • (2011) Circulation , vol.123 , pp. 1138-1143
    • Appel, L.J.1    Frohlich, E.D.2    Hall, J.E.3    Pearson, T.A.4    Sacco, R.L.5    Seals, D.R.6
  • 9
    • 84927174943 scopus 로고    scopus 로고
    • Dietary sodium restriction: a neglected therapeutic opportunity in chronic kidney disease
    • COI: 1:CAS:528:DC%2BC2cXhslCjurzE, PID: 25222815
    • Humalda JK, Navis G. Dietary sodium restriction: a neglected therapeutic opportunity in chronic kidney disease. Curr Opin Nephrol Hypertens. 2014;23:533–40.
    • (2014) Curr Opin Nephrol Hypertens , vol.23 , pp. 533-540
    • Humalda, J.K.1    Navis, G.2
  • 10
    • 61549089295 scopus 로고    scopus 로고
    • Fluid retention is associated with cardiovascular mortality in patients undergoing long-term hemodialysis
    • PID: 19171851
    • Kalantar-Zadeh K, Regidor DL, Kovesdy CP, Van Wyck D, Bunnapradist S, Horwich TB, et al. Fluid retention is associated with cardiovascular mortality in patients undergoing long-term hemodialysis. Circulation. 2009;119:671–9.
    • (2009) Circulation , vol.119 , pp. 671-679
    • Kalantar-Zadeh, K.1    Regidor, D.L.2    Kovesdy, C.P.3    Van Wyck, D.4    Bunnapradist, S.5    Horwich, T.B.6
  • 11
    • 84870949675 scopus 로고    scopus 로고
    • Sodium, blood pressure, and cardiovascular disease: further evidence supporting the American Heart Association sodium reduction recommendations
    • COI: 1:CAS:528:DC%2BC38XhvVeksr%2FJ, PID: 23124030
    • Whelton PK, Appel LJ, Sacco RL, Anderson CA, Antman EM, Campbell N, et al. Sodium, blood pressure, and cardiovascular disease: further evidence supporting the American Heart Association sodium reduction recommendations. Circulation. 2012;126:2880–9.
    • (2012) Circulation , vol.126 , pp. 2880-2889
    • Whelton, P.K.1    Appel, L.J.2    Sacco, R.L.3    Anderson, C.A.4    Antman, E.M.5    Campbell, N.6
  • 13
    • 84908249665 scopus 로고    scopus 로고
    • Vascular toxicity of phosphate in chronic kidney disease: beyond vascular calcification
    • COI: 1:CAS:528:DC%2BC2cXitV2jt7bF, PID: 25077548
    • Gross P, Six I, Kamel S, Massy ZA. Vascular toxicity of phosphate in chronic kidney disease: beyond vascular calcification. Circ J. 2014;78:2339–46.
    • (2014) Circ J , vol.78 , pp. 2339-2346
    • Gross, P.1    Six, I.2    Kamel, S.3    Massy, Z.A.4
  • 14
    • 85047687476 scopus 로고    scopus 로고
    • Roles of phosphate and fibroblast growth factor 23 in cardiovascular disease
    • COI: 1:CAS:528:DC%2BC2cXls1Kntb0%3D, PID: 24686452
    • Scialla JJ, Wolf M. Roles of phosphate and fibroblast growth factor 23 in cardiovascular disease. Nat Rev Nephrol. 2014;10:268–78.
    • (2014) Nat Rev Nephrol , vol.10 , pp. 268-278
    • Scialla, J.J.1    Wolf, M.2
  • 15
    • 84925269559 scopus 로고    scopus 로고
    • Evidence-based clinical practice guideline for CKD 2013
    • Japanese Society of Nephrology. Evidence-based clinical practice guideline for CKD 2013. Clin Exp Nephrol. 2013;18:346–423.
    • (2013) Clin Exp Nephrol , vol.18 , pp. 346-423
  • 16
    • 0030868530 scopus 로고    scopus 로고
    • Stool form scale as a useful guide to intestinal transit time
    • COI: 1:STN:280:DyaK2svksVCntw%3D%3D, PID: 9299672
    • Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997;32:920–4.
    • (1997) Scand J Gastroenterol , vol.32 , pp. 920-924
    • Lewis, S.J.1    Heaton, K.W.2
  • 18
    • 84899772214 scopus 로고    scopus 로고
    • Interdialytic weight gain and cardiovascular outcome in incident hemodialysis patients
    • COI: 1:CAS:528:DC%2BC2cXps1Wjtrs%3D, PID: 24819227
    • Lee MJ, Doh FM, Kim CH, Koo HM, Oh HJ, Park JT, et al. Interdialytic weight gain and cardiovascular outcome in incident hemodialysis patients. Am J Nephrol. 2014;39:427–35.
    • (2014) Am J Nephrol , vol.39 , pp. 427-435
    • Lee, M.J.1    Doh, F.M.2    Kim, C.H.3    Koo, H.M.4    Oh, H.J.5    Park, J.T.6
  • 19
    • 60749115069 scopus 로고    scopus 로고
    • The benefit of salt restriction in the treatment of end-stage renal disease by haemodialysis
    • PID: 19004849
    • Kayikcioglu M, Tumuklu M, Ozkahya M, Ozdogan O, Asci G, Duman S, et al. The benefit of salt restriction in the treatment of end-stage renal disease by haemodialysis. Nephrol Dial Transplant. 2009;24:956–62.
    • (2009) Nephrol Dial Transplant , vol.24 , pp. 956-962
    • Kayikcioglu, M.1    Tumuklu, M.2    Ozkahya, M.3    Ozdogan, O.4    Asci, G.5    Duman, S.6
  • 20
    • 0033653434 scopus 로고    scopus 로고
    • Dietary salt intake and blood pressure control in haemodialysis patients
    • COI: 1:STN:280:DC%2BD3M7it1ChsQ%3D%3D, PID: 11096160
    • Maduell F, Navarro V. Dietary salt intake and blood pressure control in haemodialysis patients. Nephrol Dial Transplant. 2000;15:2063.
    • (2000) Nephrol Dial Transplant , vol.15 , pp. 2063
    • Maduell, F.1    Navarro, V.2
  • 21
    • 68949114585 scopus 로고    scopus 로고
    • Improving Global Outcomes (KDIGO) CKD-MBD Work Group. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD)
    • Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD). Kidney Int Suppl. 2009;76:S1–130.
    • (2009) Kidney Int Suppl , vol.76 , pp. S1-S130
  • 22
    • 5644225678 scopus 로고    scopus 로고
    • Magnitude and impact of abnormal mineral metabolism in hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS)
    • PID: 15486872
    • Young EW, Akiba T, Albert JM, McCarthy JT, Kerr PG, Mendelssohn DC, et al. Magnitude and impact of abnormal mineral metabolism in hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2004;44:34–8.
    • (2004) Am J Kidney Dis , vol.44 , pp. 34-38
    • Young, E.W.1    Akiba, T.2    Albert, J.M.3    McCarthy, J.T.4    Kerr, P.G.5    Mendelssohn, D.C.6
  • 23
    • 1542288794 scopus 로고    scopus 로고
    • Calcium, phosphate, and parathyroid hormone levels in combination and as a function of dialysis duration predict mortality: evidence for the complexity of the association between mineral metabolism and outcomes
    • COI: 1:CAS:528:DC%2BD2cXhtlShtbk%3D, PID: 14978180
    • Stevens LA, Djurdjev O, Cardew S, Cameron EC, Levin A. Calcium, phosphate, and parathyroid hormone levels in combination and as a function of dialysis duration predict mortality: evidence for the complexity of the association between mineral metabolism and outcomes. J Am Soc Nephrol. 2004;15:770–9.
    • (2004) J Am Soc Nephrol , vol.15 , pp. 770-779
    • Stevens, L.A.1    Djurdjev, O.2    Cardew, S.3    Cameron, E.C.4    Levin, A.5
  • 24
    • 36048942723 scopus 로고    scopus 로고
    • High plasma phosphate as a risk factor for decline in renal function and mortality in pre-dialysis patients
    • COI: 1:CAS:528:DC%2BD2sXhtFWhur%2FF, PID: 17517792
    • Voormolen N, Noordzij M, Grootendorst DC, Beetz I, Sijpkens YW, van Manen JG, et al. High plasma phosphate as a risk factor for decline in renal function and mortality in pre-dialysis patients. Nephrol Dial Transplant. 2007;22:2909–16.
    • (2007) Nephrol Dial Transplant , vol.22 , pp. 2909-2916
    • Voormolen, N.1    Noordzij, M.2    Grootendorst, D.C.3    Beetz, I.4    Sijpkens, Y.W.5    van Manen, J.G.6
  • 25
    • 84884293874 scopus 로고    scopus 로고
    • Improving Global Outcomes (KDIGO) Blood Pressure Work Group. KDIGO clinical practice guideline for the management of blood pressure in chronic kidney disease
    • Kidney Disease: Improving Global Outcomes (KDIGO) Blood Pressure Work Group. KDIGO clinical practice guideline for the management of blood pressure in chronic kidney disease. Kidney Int Suppl. 2012;2:337–414.
    • (2012) Kidney Int Suppl , vol.2 , pp. 337-414
  • 26
    • 0030612696 scopus 로고    scopus 로고
    • RenaGel, a novel calcium- and aluminium-free phosphate binder, inhibits phosphate absorption in normal volunteers
    • COI: 1:CAS:528:DyaK2sXlvV2ns74%3D, PID: 9269642
    • Burke SK, Slatopolsky EA, Goldberg DI. RenaGel, a novel calcium- and aluminium-free phosphate binder, inhibits phosphate absorption in normal volunteers. Nephrol Dial Transplant. 1997;12:1640–4.
    • (1997) Nephrol Dial Transplant , vol.12 , pp. 1640-1644
    • Burke, S.K.1    Slatopolsky, E.A.2    Goldberg, D.I.3
  • 30
    • 84856988935 scopus 로고    scopus 로고
    • Visceral antinociceptive effects of RDX5791, a first-in-class minimally systemic NHE3 inhibitor on stress-induced colorectal hypersensitivity to distension in rats
    • Eutamene H, Charmot D, Navre M, Bueno L. Visceral antinociceptive effects of RDX5791, a first-in-class minimally systemic NHE3 inhibitor on stress-induced colorectal hypersensitivity to distension in rats. Gastroenterology. 2011;140:S-57–8.
    • (2011) Gastroenterology , vol.140 , pp. 57-58
    • Eutamene, H.1    Charmot, D.2    Navre, M.3    Bueno, L.4
  • 31
    • 85020364525 scopus 로고    scopus 로고
    • Ardelyx. A randomized, double-blind, placebo-controlled study to assess the safety and efficacy of AZD1722 for the treatment of constipation-predominant irritable bowel syndrome (IBS-C)
    • Accessed 14 March 2016
    • Ardelyx. A randomized, double-blind, placebo-controlled study to assess the safety and efficacy of AZD1722 for the treatment of constipation-predominant irritable bowel syndrome (IBS-C). Available from: ClinicalTrials.gov. http://clinicaltrials.gov/ct2/show/NCT01923428. Accessed 14 March 2016.
    • ClinicalTrials.gov
  • 32
    • 85020346988 scopus 로고    scopus 로고
    • Ardelyx. A 26-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of tenapanor for the treatment of constipation-predominant irritable bowel syndrome (IBS-C)
    • Accessed 22 April 2016
    • Ardelyx. A 26-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of tenapanor for the treatment of constipation-predominant irritable bowel syndrome (IBS-C). Available from: ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02686138. Accessed 22 April 2016.
    • ClinicalTrials.gov
  • 33
    • 85020349607 scopus 로고    scopus 로고
    • Efficacy and safety of tenapanor in patients with constipation predominant irritable bowel syndrome: a 12-week, double-blind, placebo-controlled, randomized phase 2b trial
    • Chey WD, Lembo AJ, Phillips JA, Rosenbaum DP. Efficacy and safety of tenapanor in patients with constipation predominant irritable bowel syndrome: a 12-week, double-blind, placebo-controlled, randomized phase 2b trial. Gastroenterology. 2015;148:S-191–2.
    • (2015) Gastroenterology , vol.148 , pp. 191-192
    • Chey, W.D.1    Lembo, A.J.2    Phillips, J.A.3    Rosenbaum, D.P.4


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