메뉴 건너뛰기




Volumn 8, Issue 2, 2011, Pages 165-174

The use of group sequential, information-based sample size re-estimation in the design of the PRIMO study of chronic kidney disease

(17)  Pritchett, Yili a   Jemiai, Yannis b   Chang, Yuchiao c   Bhan, Ishir c   Agarwal, Rajiv d   Zoccali, Carmine e   Wanner, Christoph f   Lloyd Jones, Donald g   Cannata Andía, Jorge B h   Thompson, Taylor c   Appelbaum, Evan i   Audhya, Paul a   Andress, Dennis a   Zhang, Wuyan a   Solomon, Scott i   Manning, Warren J i   Thadhani, Ravi c  


Author keywords

[No Author keywords available]

Indexed keywords

PARICALCITOL; PLACEBO;

EID: 79959252941     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774511399128     Document Type: Review
Times cited : (19)

References (49)
  • 2
    • 1442265460 scopus 로고    scopus 로고
    • Disparities in premature deaths from heart disease-50 states and the district of Columbia, 2001
    • Department of Health and Human Services
    • Department of Health and Human Services. Disparities in premature deaths from heart disease-50 states and the district of Columbia, 2001. MMWR Morb Mortal Wkly Rep 2004; 53: 121-25.
    • (2004) MMWR Morb Mortal Wkly Rep , vol.53 , pp. 121-125
  • 3
    • 0025280867 scopus 로고
    • Prognostic implications of echocardiographically determined left ventricular mass in the Framingham Heart Study
    • Levy D, Garrison RJ, Savage DD, et al. Prognostic implications of echocardiographically determined left ventricular mass in the Framingham Heart Study. N Engl J Med 1990; 322: 1561-66. (Pubitemid 20176696)
    • (1990) New England Journal of Medicine , vol.322 , Issue.22 , pp. 1561-1566
    • Levy, D.1    Garrison, R.J.2    Savage, D.D.3    Kannel, W.B.4    Castelli, W.P.5
  • 4
    • 0026786643 scopus 로고
    • Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction. Results of the survival and ventricular enlargement trial. The SAVE Investigators
    • Pfeffer MA, Braunwald E, Moye LA, et al. Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction. Results of the survival and ventricular enlargement trial. The SAVE Investigators. N Engl J Med 1992; 327: 669-77.
    • (1992) N Engl J Med , vol.327 , pp. 669-677
    • Pfeffer, M.A.1    Braunwald, E.2    Moye, L.A.3
  • 11
    • 49649111989 scopus 로고    scopus 로고
    • Association of oral calcitriol with improved survival in nondialyzed CKD
    • Shoben AB, Rudser KD, de Boer IH, et al. Association of oral calcitriol with improved survival in nondialyzed CKD. J Am Soc Nephrol 2008; 19: 1613-19.
    • (2008) J Am Soc Nephrol , vol.19 , pp. 1613-1619
    • Shoben, A.B.1    Rudser, K.D.2    De Boer, I.H.3
  • 12
    • 40449107836 scopus 로고    scopus 로고
    • Association of activated vitamin D treatment and mortality in chronic kidney disease
    • DOI 10.1001/archinternmed.2007.110
    • Kovesdy CP, Ahmadzadeh S, Anderson JE, Kalantar-Zadeh K. Association of activated vitamin D treatment and mortality in chronic kidney disease. Arch Intern Med 2008; 168: 397-403. (Pubitemid 351350586)
    • (2008) Archives of Internal Medicine , vol.168 , Issue.4 , pp. 397-403
    • Kovesdy, C.P.1    Ahmadzadeh, S.2    Anderson, J.E.3    Kalantar-Zadeh, K.4
  • 13
    • 53049103995 scopus 로고    scopus 로고
    • Oral active vitamin D is associated with improved survival in hemodialysis patients
    • Naves-Diaz M, Alvarez-Hernandez D, Passlick-Deetjen J, et al. Oral active vitamin D is associated with improved survival in hemodialysis patients. Kidney Int 2008; 74: 1070-78.
    • (2008) Kidney Int , vol.74 , pp. 1070-1078
    • Naves-Diaz, M.1    Alvarez-Hernandez, D.2    Passlick-Deetjen, J.3
  • 15
    • 46249130272 scopus 로고    scopus 로고
    • Targeted ablation of the vitamin D 1alpha-hydroxylase gene: Getting to the heart of the matter
    • DOI 10.1038/ki.2008.219, PII KI2008219
    • Thadhani R. Targeted ablation of the vitamin D 1alpha-hydroxylase gene: getting to the heart of the matter. Kidney Int 2008; 74: 141-43. (Pubitemid 351915094)
    • (2008) Kidney International , vol.74 , Issue.2 , pp. 141-143
    • Thadhani, R.1
  • 16
    • 0023160699 scopus 로고
    • Vitamin D3 and cardiovascular function in rats
    • Weishaar RE, Simpson RU. Vitamin D3 and cardiovascular function in rats. J Clin Invest 1987; 79: 1706-12.
    • (1987) J Clin Invest , vol.79 , pp. 1706-1712
    • Weishaar, R.E.1    Simpson, R.U.2
  • 17
    • 33947230704 scopus 로고    scopus 로고
    • Characterization of heart size and blood pressure in the vitamin D receptor knockout mouse
    • DOI 10.1016/j.jsbmb.2006.12.098, PII S096007600600464X
    • Simpson RU, Hershey SH, Nibbelink KA. Characterization of heart size and blood pressure in the vitamin D receptor knockout mouse. J Steroid Biochem Mol Biol 2007; 103: 521-24. (Pubitemid 46420533)
    • (2007) Journal of Steroid Biochemistry and Molecular Biology , vol.103 , Issue.3-5 , pp. 521-524
    • Simpson, R.U.1    Hershey, S.H.2    Nibbelink, K.A.3
  • 18
    • 19944425466 scopus 로고    scopus 로고
    • Cardiac hypertrophy in vitamin D receptor knockout mice: Role of the systemic and cardiac renin-angiotensin systems
    • Xiang W, Kong J, Chen S, et al. Cardiac hypertrophy in vitamin D receptor knockout mice: role of the systemic and cardiac renin-angiotensin systems. Am J Physiol Endocrinol Metab 2005; 288: E125-32.
    • (2005) Am J Physiol Endocrinol Metab , vol.288
    • Xiang, W.1    Kong, J.2    Chen, S.3
  • 19
    • 0029916947 scopus 로고    scopus 로고
    • 3and retinoic acid antagonize endothelin-stimulated hypertrophy of neonatal rat cardiac myocytes
    • Wu J, Garami M, Cheng T, Gardner DG. 1,25(OH)2 vitamin D3, and retinoic acid antagonize endothelin-stimulated hypertrophy of neonatal rat cardiac myocytes. J Clin Invest 1996; 97: 1577-88. (Pubitemid 26105467)
    • (1996) Journal of Clinical Investigation , vol.97 , Issue.7 , pp. 1577-1588
    • Wu, J.1    Garami, M.2    Cheng, T.3    Gardner, D.G.4
  • 20
    • 78651409106 scopus 로고    scopus 로고
    • Vitamin D receptor activation and left ventricular hypertrophy in advanced kidney disease
    • Thadhani R, Appelbaum E, Chang Y, et al. Vitamin D receptor activation and left ventricular hypertrophy in advanced kidney disease. Am J Nephrol 2011; 33: 139-49.
    • (2011) Am J Nephrol , vol.33 , pp. 139-149
    • Thadhani, R.1    Appelbaum, E.2    Chang, Y.3
  • 24
    • 0028927470 scopus 로고
    • Magnetic resonance imaging compared to echocardiography to assess left ventricular mass in the hypertensive patient
    • Bottini PB, Carr AA, Prisant LM, et al. Magnetic resonance imaging compared to echocardiography to assess left ventricular mass in the hypertensive patient. Am J Hypertens 1995; 8: 221-28.
    • (1995) Am J Hypertens , vol.8 , pp. 221-228
    • Bottini, P.B.1    Carr, A.A.2    Prisant, L.M.3
  • 26
    • 0036098910 scopus 로고    scopus 로고
    • Regression of left ventricular hypertrophy after conversion to nocturnal hemodialysis
    • DOI 10.1046/j.1523-1755.2002.00362.x
    • Chan CT, Floras JS, Miller JA, et al. Regression of left ventricular hypertrophy after conversion to nocturnal hemodialysis. Kidney Int 2002; 61: 2235-39. (Pubitemid 34539341)
    • (2002) Kidney International , vol.61 , Issue.6 , pp. 2235-2239
    • Chan, C.T.1    Floras, J.S.2    Miller, J.A.3    Richardson, R.M.A.4    Pierratos, A.5
  • 27
    • 0028619850 scopus 로고
    • Evaluation of experiments with adaptive interim analyses
    • Bauer P, Kohne K. Evaluation of experiments with adaptive interim analyses. Biometrics 1994; 50: 1029-41.
    • (1994) Biometrics , vol.50 , pp. 1029-1041
    • Bauer, P.1    Kohne, K.2
  • 28
    • 0032732411 scopus 로고    scopus 로고
    • Adaptive sample size calculations in group sequential trials
    • Lehmacher W, Wassmer G. Adaptive sample size calculations in group sequential trials. Biometrics 1999; 55: 1286-90.
    • (1999) Biometrics , vol.55 , pp. 1286-1290
    • Lehmacher, W.1    Wassmer, G.2
  • 29
    • 0034876356 scopus 로고    scopus 로고
    • Adaptive group sequential designs for clinical trials: Combining the advantages of adaptive and of classical group sequential approaches
    • Muller HH, Schafer H. Adaptive group sequential designs for clinical trials: combining the advantages of adaptive and of classical group sequential approaches. Biometrics 2001; 57: 886-91. (Pubitemid 32801186)
    • (2001) Biometrics , vol.57 , Issue.3 , pp. 886-891
    • Muller, H.-H.1    Schafer, H.2
  • 30
    • 0032886394 scopus 로고    scopus 로고
    • Modification of sample size in group sequential clinical trials
    • Chi L, Hung HM, Wang SJ. Modification of sample size in group sequential clinical trials. Biometrics 1999; 55: 853-57. (Pubitemid 29427088)
    • (1999) Biometrics , vol.55 , Issue.3 , pp. 853-857
    • Cui, L.1    Hung, H.M.J.2    Wang, S.-J.3
  • 32
    • 0242694372 scopus 로고    scopus 로고
    • Acute Stroke Therapy by Inhibition of Neutrophils (ASTIN): An Adaptive Dose-Response Study of UK-279,276 in Acute Ischemic Stroke
    • DOI 10.1161/01.STR.0000092527.33910.89
    • Krams M, Lees KR, Hacke W, et al. Acute Stroke Therapy by Inhibition of Neutrophils (ASTIN): an adaptive dose-response study of UK-279,276 in acute ischemic stroke. Stroke 2003; 34: 2543-48. (Pubitemid 37392736)
    • (2003) Stroke , vol.34 , Issue.11 , pp. 2543-2548
    • Krams, M.1    Lees, K.R.2    Hacke, W.3    Grieve, A.P.4    Orgogozo, J.-M.5    Ford, G.A.6
  • 33
    • 65649108950 scopus 로고    scopus 로고
    • Adjuvant chemotherapy in older women with early-stage breast cancer
    • Muss HB, Berry DA, Cirrincione CT, et al. Adjuvant chemotherapy in older women with early-stage breast cancer. N Engl J Med 2009; 360: 2055-65.
    • (2009) N Engl J Med , vol.360 , pp. 2055-2065
    • Muss, H.B.1    Berry, D.A.2    Cirrincione, C.T.3
  • 34
    • 33748576736 scopus 로고    scopus 로고
    • Adaptive, group sequential and decision theoretic approaches to sample size determination
    • discussion 3297-301, 3302-04, 3313-14, 3326-47
    • Mehta CR, Patel NR. Adaptive, group sequential and decision theoretic approaches to sample size determination. Stat Med 2006; 25: 3250-69; discussion 3297-301, 3302-04, 3313-14, 3326-47.
    • (2006) Stat Med , vol.25 , pp. 3250-3269
    • Mehta, C.R.1    Patel, N.R.2
  • 35
    • 33846642617 scopus 로고    scopus 로고
    • Target Level for Hemoglobin Correction in Patients with Diabetes and CKD: Primary Results of the Anemia Correction in Diabetes (ACORD) Study
    • DOI 10.1053/j.ajkd.2006.11.032, PII S0272638606017069
    • Ritz E, Laville M, Bilous RW, et al. Target level for hemoglobin correction in patients with diabetes and CKD: primary results of the Anemia Correction in Diabetes (ACORD) Study. Am J Kidney Dis 2007; 49: 194-207. (Pubitemid 46178405)
    • (2007) American Journal of Kidney Diseases , vol.49 , Issue.2 , pp. 194-207
    • Ritz, E.1    Laville, M.2    Bilous, R.W.3    O'Donoghue, D.4    Scherhag, A.5    Burger, U.6    De Alvaro, F.7
  • 39
    • 0142085752 scopus 로고    scopus 로고
    • Effects of Eplerenone, Enalapril, and Eplerenone/Enalapril in Patients with Essential Hypertension and Left Ventricular Hypertrophy: The 4E-Left Ventricular Hypertrophy Study
    • DOI 10.1161/01.CIR.0000091405.00772.6E
    • Pitt B, Reichek N, Willenbrock R, et al. Effects of eplerenone, enalapril, and eplerenone/enalapril in patients with essential hypertension and left ventricular hypertrophy: the 4 E-left ventricular hypertrophy study. Circulation 2003; 108: 1831-38. (Pubitemid 37296092)
    • (2003) Circulation , vol.108 , Issue.15 , pp. 1831-1838
    • Pitt, B.1    Reichek, N.2    Willenbrock, R.3    Zannad, F.4    Phillips, R.A.5    Roniker, B.6    Kleiman, J.7    Krause, S.8    Burns, D.9    Williams, G.H.10
  • 40
    • 61349170589 scopus 로고    scopus 로고
    • Effect of the direct Renin inhibitor aliskiren, the Angiotensin receptor blocker losartan, or both on left ventricular mass in patients with hypertension and left ventricular hypertrophy
    • Solomon SD, Appelbaum E, Manning WJ, et al. Effect of the direct Renin inhibitor aliskiren, the Angiotensin receptor blocker losartan, or both on left ventricular mass in patients with hypertension and left ventricular hypertrophy. Circulation 2009; 119: 530-37.
    • (2009) Circulation , vol.119 , pp. 530-537
    • Solomon, S.D.1    Appelbaum, E.2    Manning, W.J.3
  • 42
    • 0035739842 scopus 로고    scopus 로고
    • Flexible sample size considerations using information-based interim monitoring
    • Mehta C, Tsiatis AA. Flexible sample size consideration using information-based interim monitoring. Drug Infor J 2001; 35: 1095-112. (Pubitemid 34563404)
    • (2001) Drug Information Journal , vol.35 , Issue.4 , pp. 1095-1112
    • Mehta, C.R.1    Tsiatis, A.A.2
  • 43
    • 0000065971 scopus 로고
    • Sample size re-estimation without unblinding for normally distributed outcomes with unknown variance
    • Gould AL, Shih WJ. Sample size re-estimation without unblinding for normally distributed outcomes with unknown variance. Com Stat Theory Meth 1992; 21: 2833-53.
    • (1992) Com Stat Theory Meth , vol.21 , pp. 2833-2853
    • Gould, A.L.1    Shih, W.J.2
  • 44
    • 0017744944 scopus 로고
    • Group sequential methods in the design and analysis of clinical trials
    • Pocock SJ. Group sequential methods in the design and analysis of clinical trials. Biometrika 1977; 64: 191-99. (Pubitemid 8145484)
    • (1977) Biometrika , vol.64 , Issue.2 , pp. 191-199
    • Pocock, S.J.1
  • 45
    • 0018687930 scopus 로고
    • A multiple testing procedure for clinical trials
    • DOI 10.2307/2530245
    • O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979; 35: 549-56. (Pubitemid 10242750)
    • (1979) Biometrics , vol.35 , Issue.3 , pp. 549-556
    • O'Brien, P.C.1    Fleming, T.R.2
  • 46
    • 70449529019 scopus 로고
    • Discrete sequential boundaries for clinical trials
    • Lan KKG, De Mets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70: 659-63.
    • (1983) Biometrika , vol.70 , pp. 659-663
    • Lan, K.K.G.1    De Mets, D.L.2
  • 47
    • 0025598008 scopus 로고
    • Group sequential designs using a family of type I error probability spending functions
    • Hwang IK, Shih WJ, De Cani JS. Group sequential designs using a family of type I error probability spending functions. Stat Med 1990; 9: 1439-45.
    • (1990) Stat Med , vol.9 , pp. 1439-1445
    • Hwang, I.K.1    Shih, W.J.2    De Cani, J.S.3
  • 48
    • 0037305101 scopus 로고    scopus 로고
    • Practical midcourse sample size modification in clinical trials
    • DOI 10.1016/S0197-2456(02)00240-4, PII S0197245602002404
    • Proschan MA, Liu Q, Hunsberger S. Practical midcourse sample size modification in clinical trials. Control Clin Trials 2003; 24: 4-15. (Pubitemid 36135942)
    • (2003) Controlled Clinical Trials , vol.24 , Issue.1 , pp. 4-15
    • Proschan, M.A.1    Liu, Q.2    Hunsberger, S.3
  • 49
    • 61349150491 scopus 로고    scopus 로고
    • Optimizing trial design: Sequential, adaptive, and enrichment strategies
    • Mehta C, Gao P, Bhatt DL, et al. Optimizing trial design: sequential, adaptive, and enrichment strategies. Circulation 2009; 119: 597-605.
    • (2009) Circulation , vol.119 , pp. 597-605
    • Mehta, C.1    Gao, P.2    Bhatt, D.L.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.