Effect of statin therapy on disease progression in pediatric ADPKD: design and baseline characteristics of participants.
Autosomal dominant polycystic kidney disease (ADPKD) is the most common genetic kidney condition and is associated with important renal and cardiovascular manifestations in childhood. Renal cystic disease can be documented in some cases as early as in utero. Early intervention is critical if the long-term complications of this condition, including end-stage renal disease, are to be ameliorated. Here we describe our ongoing randomized double-blind placebo-controlled phase III clinical trial to assess the effect of pravastatin treatment on renal and cardiovascular disease progression in 107 children and young adults age 8-22 years with ADPKD who are receiving the angiotensin converting enzyme inhibitor lisinopril. Baseline demographic and laboratory data are provided. Results of this study could markedly impact the standard of care for evaluation and treatment of ADPKD in this population.
Department of Medicine, University of Colorado Denver, Aurora, CO, USA. Melissa.Cadnapaphornchai@ucdenver.edu
Melissa A
MA
Cadnapaphornchai
Diana M
DM
George
Amirali
A
Masoumi
Kim
K
McFann
John D
JD
Strain
Robert W
RW
Schrier
D000293:Adolescent; D000328:Adult; D000419:Albuminuria / Q000188:drug therapy / Q000209:etiology; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D002648:Child; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D006973:Hypertension / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D017379:Hypertrophy, Left Ventricular / Q000188:drug therapy / Q000209:etiology; D007668:Kidney / Q000187:drug effects / Q000473:pathology; D017706:Lisinopril / Q000494:pharmacology / Q000627:therapeutic use; D008297:Male; D016891:Polycystic Kidney, Autosomal Dominant / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D017035:Pravastatin / Q000494:pharmacology / Q000627:therapeutic use*; D012084:Renin-Angiotensin System / Q000187:drug effects / Q000502:physiology; D055815:Young Adult
D000806:Angiotensin-Converting Enzyme Inhibitors; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D017706:Lisinopril; D017035:Pravastatin
J Urol. 1996 Jul;156(1):249-52
8648816
Clin J Am Soc Nephrol. 2011 Feb;6(2):369-76
21115621
Kidney Int. 1994 Oct;46(4):1118-23
7861706
Am J Kidney Dis. 2002 Jun;39(6):1127-34
12046022
J Am Soc Nephrol. 1997 Aug;8(8):1292-7
9259356
Nephrol Dial Transplant. 2001 Nov;16(11):2152-7
11682660
J Membr Biol. 2003 Feb 1;191(3):193-200
12571753
Urology. 1996 Dec;48(6):862-7
8973668
J Am Soc Nephrol. 2001 Jan;12(1):194-200
11134267
Kidney Int. 2000 Oct;58(4):1420-30
11012877
BMJ. 2001 Mar 3;322(7285):531-6
11230071
J Am Soc Nephrol. 1994 Mar;4(9):1654-60
8011974
N Engl J Med. 1990 Oct 18;323(16):1091-6
2215576
J Comput Assist Tomogr. 2000 Jul-Aug;24(4):614-9
10966197
Am J Kidney Dis. 2005 Dec;46(6):1058-64
16310571
Nat Clin Pract Nephrol. 2006 Jan;2(1):40-55; quiz 55
16932388
Annu Rev Med. 1968;19:283-300
4297619
Clin Exp Pharmacol Physiol. 1999 Nov;26(11):903-8
10561812
Kidney Int. 1997 Dec;52(6):1497-510
9407495
Urology. 1997 Nov;50(5):812-7
9372901
J Am Soc Nephrol. 2009 Sep;20(9):1888-93
19696226
Scand J Urol Nephrol. 1998 Sep;32(5):356-9
9825400
J Am Soc Nephrol. 1995 Jun;5(12):2048-56
7579053
Nat Genet. 2003 Feb;33(2):129-37
12514735
Circulation. 1997 Feb 4;95(3):588-93
9024144
Pediatrics. 2004 Aug;114(2 Suppl 4th Report):555-76
15286277
Am J Nephrol. 2001 Nov-Dec;21(6):449-54
11799261
Arch Dis Child. 1969 Jun;44(235):291-303
5785179
J Am Soc Nephrol. 2004 Oct;15(10):2528-36
15466257
J Biol Chem. 1996 Sep 20;271(38):23317-21
8798532
Clin J Am Soc Nephrol. 2010 Jan;5(1):102-9
20089507
Am J Cardiol. 2001 Apr 19;87(8A):3C-9C
11334762
Kidney Int. 1992 May;41(5):1311-9
1614046
Am J Kidney Dis. 2003 Mar;41(3):565-70
12612979
Am J Pathol. 1987 Oct;129(1):92-101
3310652
Kidney Int. 2008 Nov;74(9):1192-6
18716604
Kidney Int. 1997 Sep;52(3):699-705
9291190
Circulation. 1991 Jan;83(1):13-25
1824620
J Am Soc Nephrol. 1998 Oct;9(10):1908-14
9773792
Kidney Int. 1988 Nov;34(5):683-90
2974094
Kidney Int. 1989 Feb;35(2):675-80
2709672
Kidney Int Suppl. 1997 Dec;63:S93-7
9407432
J Am Soc Nephrol. 2002 Jul;13(7):1733-9
12089368
Am J Kidney Dis. 1992 Aug;20(2):140-3
1496966
Am J Hypertens. 2001 Jun;14(6 Pt 2):55S-61S
11411766
Kidney Int. 1991 Sep;40(3):501-8
1838571
Lancet. 1999 Jan 9;353(9147):103-7
10023895
Am J Med Sci. 1999 Apr;317(4):215-21
10210355
Kidney Int. 1990 Dec;38(6):1177-80
2074659
Kidney Int. 1983 Mar;23(3):526-9
6405076
Am J Kidney Dis. 1983 May;2(6):630-9
6846334
Pediatrics. 1976 Aug;58(2):259-63
951142
J Am Soc Nephrol. 2000 Aug;11(8):1505-1511
10906164
Arch Dis Child. 1970 Feb;45(239):13-23
5440182
Kidney Int. 1993 Nov;44(5):1101-8
8264142
Clin J Am Soc Nephrol. 2007 Jan;2(1):112-20
17699395
Hypertension. 1997 Jan;29(1 Pt 2):366-73
9039129
Kidney Int. 2003 Feb;63(2):678-85
12631134
Am J Kidney Dis. 1995 Sep;26(3):501-7
7645559
N Engl J Med. 2010 Aug 26;363(9):820-9
20581391
Clin J Am Soc Nephrol. 2009 Apr;4(4):820-9
19346430
Nephrol Dial Transplant. 1999;14 Suppl 1:42-4
10048448
Am J Cardiol. 2002 Jul 1;90(1):29-34
12088775
Eur J Cardiothorac Surg. 2003 Jul;24(1):59-65
12853046
N Engl J Med. 2010 Aug 26;363(9):830-40
20581392
Circulation. 1993 Apr;87(4):1328-39
8384939
Kidney Int. 2003 Sep;64(3):1035-45
12911554
Contemp Clin Trials. 2005 Apr;26(2):211-22
15837441
J Surg Res. 2001 Nov;101(1):79-84
11676559
Aten Primaria. 2000 Feb 15;25(2):96-102
10736939
J Am Soc Nephrol. 1995 Jun;5(12):2032-6
7579051
Am J Physiol Renal Physiol. 2007 Sep;293(3):F854-9
17581927
J Am Soc Nephrol. 2002 Oct;13(10):2508-16
12239239
J Clin Endocrinol Metab. 2002 Apr;87(4):1451-8
11932263
Am J Cardiol. 1990 Oct 2;66(11):22D-30D; discussion 30D-32D
2220602
J Am Soc Nephrol. 1994 Dec;5(6):1349-54
7894001