Table 1. Baseline Study Characteristics of All Studies in Phase 1.
| STUDY | Sample | Follow up | Age (y) | Male | Clinical | Baseline Renal Function Indicators | Co-Morbidities (%) | Country | |||||
| Size | in years (mean/median) | mean | (%) | Setting | sCr eGFR/CrCl MicroAlb MacroAlb mg/dl ml/min/1.73 m2 (%) (%) | DM HTN CVD | |||||||
| UKPDS34 1998 | 753 | 10.7 | 53 | 46 | T2DM | 0.9 (0.7–1.1) | – | 0 | 2.2 | 100 | UK | ||
| UKPDS33 1998 | 3867 | 10 | 53.3 | 61 | T2DM | 0.9 (0.7–1.1) | – | 0 | 1.9 | 100 | UK | ||
| Rachmani R et al 2004 | 141 | 7.7 | 57.1 | 49 | T2DM, HTN | – | 106±9.5 | 100 | 0 | 100 | 100 | 0 | Israel |
| DCCT 1993 | 1441 | 6.5 | 27 | 53 | IDDM | – | 128±30 | 0 | 0 | 100 | USA, Canada | ||
| Kumamoto 1995 | 110 | 6 | 49 | 44.5 | T2DM | – | – | 46 | 0 | 100 | 0 | 0 | Japan |
| VADT 2009 | 1791 | 5.6 | 60.4 | 97 | T2DM, HTN | 1.0±0.2 | – | – | – | 100 | 72 | 40 | USA |
| 4S | 3842 | 5.5 | 60 | 69 | CHD, CKD, DM | 1.1±0.2 | 66.5±8.4 | – | – | 3.5 | 31 | 100 | Europe, USA |
| AFCAPS-TexCAPS 2010 | 4994 | 5.3 | 60 | 81.7 | HLP | 1.1±0.2 | 71±12 | – | – | 2 | 28.5 | 0 | USA |
| ADVANCE 2008 | 11140 | 5 | 66 | 57.5 | T2DM, CVD, HTN | 0.9±0.3 | – | 26.8 | 3.6 | 100 | 68.5 | 32 | Multicontinental |
| Mauer M, et al 2009 | 256 | 5 | 29.9 | 46 | T1DM | – | 129±20 | 0 | 0 | 100 | 0 | USA, Canada | |
| SHARP 2011 | 9270 | 4.9 | 62 | 63 | CKD | – | 26.6±13 | 38 | 42 | 23 | 100 | 15 | Multicontinental |
| ALLHAT_BP 2005 | 33357 | 4.8 | 67 | 52.3 | HTN, CVD, T2DM, CKD | – | 76±10 | – | – | 39 | 100 | 26 | USA, Canada |
| ALLHAT_LIPID 2008 | 10060 | 4.8 | 66.6 | 51.2 | HTN, CVD, T2DM, CKD | – | 78.5±19 | – | – | 35.1 | 100 | 36.6 | USA, Canada |
| TRANSCEND 2009 | 5926 | 4.6 | 66.9 | 57 | CVD, T2DM | 1.0±0.3 | – | 10.3 | 0 | 35.7 | 76.4 | 74.5 | Multicontinental |
| ONTARGET 2008 | 25620 | 4.6 | 66.4 | 73 | CVD, T2DM | 1.1±0.2 | – | 13.2 | – | 38 | 69 | 85 | Multicontinental |
| HOPE 2000 | 3577 | 4.5 | 65.4 | 63 | CVD, T2DM | 1.0±0.3 | – | 32 | 0 | 98 | 56 | 60 | Europe, Canada |
| BENEDICT-B 2011 | 281 | 4.5 | 62.3 | 73.7 | HTN, T2DM | 0.9±0.2 | – | 100 | 0 | 100 | 100 | – | Multicontinental |
| ADVANCE 2007 | 11140 | 4.3 | 66 | 57 | T2DM, CVD | 0.9±0.3 | 26 | 4 | 100 | 32 | Multicontinental | ||
| DIRECT 2009 | 3322 | 4 | 40.3 | 54.6 | T1DM | 1.0±0.2 | – | 0 | 0 | 100 | 23 | – | Multicontinental |
| DIABHYCAR 2004 | 4912 | 4 | 65.1 | 69.8 | T2DM | 1.0±0.2 | – | 74 | 26 | 100 | 55.7 | 24.4 | Multicontinental |
| Fogari R et al 2002 | 309 | 4 | 62 | 56 | T2DM, HTN | 1.0±0.5 | 89.6±14.1 | 100 | 0 | 100 | 100 | 0 | Italy |
| Facchini F et al 2003 | 191 | 3.9 | 59.5 | 50.5 | T2DM, CKD | 1.8±0.6 | 63±30 | 0 | 100 | 100 | USA | ||
| Steno Type 2 1999 | 160 | 3.8 | 55.1 | 74 | T2DM | 0.8±0.1 | 117±24.5 | 100 | 0 | 100 | 20 | Denmark | |
| BENEDICT 2004 | 1204 | 3.6 | 62 | 52.7 | HTN, T2DM | 0.9±0.2 | – | 0 | 0 | 100 | 100 | – | Multicontinental |
| ACCORD 2010 | 10251 | 3.5 | 62 | T2DM, CVD | 0.9 (0.7–1.0) | 90 (76–105) | 26.5 | 6.5 | 100 | USA, Canada | |||
| RENAAL 2001 | 1513 | 3.4 | 60 | 63 | T2DM, HTN, CKD | 1.9±0.5 | – | 0 | 100 | 100 | 96 | 11 | Multicontinental |
| ROADMAP 2011 | 4447 | 3.2 | 57.7 | 46.1 | T2DM | 0.8±0.2 | 84.9±17.2 | 0 | 0 | 100 | 24.8 | Multicontinental | |
| CASE-J 2008 | 4703 | 3.2 | 63.8 | 55.1 | HTN, T2DM, CVD, CKD | – | – | – | – | 43 | 100 | 43.2 | Japan |
| AIPRI 1996 | 583 | 3 | 51 | 72 | CKD | 2.1±0.6 | 42.6±11.1 | 82 | Multicontinental | ||||
| CSG 1993 | 409 | 3 | 34.5 | 53 | IDDM, HTN | 1.3±0.4 | 81.5±40.5 | 100 | 75.5 | USA | |||
| AASK 2001 | 1094 | 3 | 54.3 | 61 | CKD with HtnNS, CVD | 1.9±0.7 | 46.4±13.4 | – | 33 | 0 | 100 | 52.5 | USA |
| Hannedouche T et al 1994 | 100 | 3 | 51 | 53 | CKD, HTN | 3.0±0.1 | – | 0 | 100 | 0 | 100 | 0 | France |
| ACCOMPLISH 2010 | 11506 | 2.9 | 70 | 64 | CVD, HTN, DM, CKD | 1.3±0.3 | 63.8±14 | 35 | 19 | 59.7 | 100 | 100 | Multicontinental |
| ACTION I 2004 | 690 | 2.8 | 39 | 59.3 | T1DM, CKD | 1.6±0.4 | 60±29 | 0 | 100 | 100 | 83 | USA, Canada | |
| DIVINe 2010 | 252 | 2.7 | 60.4 | 74.5 | DM, CKD, HTN | 1.5±1.0 | 54±27 | 0 | 100 | 82 | 93.7 | 31 | Canada |
| Ruggenenti 1999 | 186 | 2.7 | 49.7 | 75 | HTN, CKD | 2±0.1 | 46.5±18.2 | 0 | 100 | 0 | 82 | – | Italy |
| IDNT 2001 | 1148 | 2.6 | 58.9 | 66.3 | T2DM, HTN, CKD | 1.6±0.5 | – | 0 | 100 | 100 | 100 | 28.6 | Multicontinental |
| ATLANTIS 2000 | 134 | 2 | 40 | 45 | IDDM, HTN | – | 104±26 | 100 | 0 | 100 | – | – | UK, Ireland |
| Laffel L, et al 1995 | 143 | 2 | 32.7 | 50.3 | T1DM | 1.1±0.2 | 80±21.5 | 100 | 0 | 100 | 0 | 0 | USA, Canada |
| MCSG 1996 | 235 | 2 | 32 | 52 | IDDM | 0.9±0.2 | 95±35.5 | 100 | 0 | 100 | 0 | 0 | Multicontinental |
| IRMA 2 2001 | 590 | 2 | 58 | 68 | T2DM, HTN, CVD | 1.0±0.1 | 109±2 | 100 | 0 | 100 | 100 | 26.6 | Multicontinental |
| Stefoni S et al 1996 | 189 | 2 | 53.2 | 67 | CKD, HTN | 2.3±0.1 | 40.8±1.5 | 0 | 100 | 0 | Italy | ||
| SURE 2009 | 205 | 2 | 66 | 66.5 | T2DM, HTN, CKD | 100 | 96 | 15 | China | ||||
| Val-HeFT 2009 | 5010 | 1.9 | 62 | 77 | CVD, CHF, CKD, DM | – | 59.8±10.5 | – | – | 33.7 | 7.5 | 45 | USA |
| Goicoechea M et al 2010 | 113 | 1.9 | 71.8 | CKD | 1.8±0.5 | 40±11.9 | 37.5 | 27.5 | Spain | ||||
| REIN 2 2005 | 335 | 1.5 | 53.7 | 75 | CKD | 2.7±1.1 | 35±18.3 | 0 | 100 | 0 | Italy | ||
| REIN 1997 | 166 | 1.3 | 49.3 | 78 | HTN, CKD | 2.4±0.9 | 38.8±18.2 | 0 | 100 | 0 | 87 | Italy | |
| BEAM 2011 | 227 | 1 | 66.8 | 56 | T2DM, CKD | 2.0±0.5 | 32.4±6.9 | 29 | 34 | 100 | USA | ||
| CAP-KD 2009 | 479 | 1 | 63 | 33 | CKD | 2.6±1.0 | 22.3±10.8 | Japan | |||||
| DIAL 2004 | 180 | 1 | 59 | 73 | T2DM, HTN | 0.8±0.2 | – | 100 | 0 | 100 | 100 | 4 | Italy |
| GUARD 2008 | 304 | 1 | 57.7 | 65.4 | T2DM, HTN | – | 90.6 (46.2–177.5) | 100 | 100 | USA | |||
| NESTOR 2004 | 570 | 1 | 60 | 64 | T2DM, HTN | – | 92.5±29.3 | 100 | 0 | 100 | 100 | Multicontinental | |