Khan E, Killackey M, Kumbala D, LaGuardia H, Liu YJ, Qin HZ, Alper B, Paramesh A, Buell J, Zhang R. Long-term outcome of ketoconazole and tacrolimus co-administration in kidney transplant patients. World J Nephrol 2014; 3(3): 107-113 [PMID: 25332902 DOI: 10.5527/wjn.v3.i3.107]
Corresponding Author of This Article
Rubin Zhang, MD, FASN, Professor of Clinical Medicine, Section of Nephrology, Department of Medicine, 1430 Tulane Ave, Box SL-45, New Orleans, LA 70112, United States. rzhang@tulane.edu
Research Domain of This Article
Clinical Neurology
Article-Type of This Article
Randomized Controlled Trial
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Nephrol. Aug 6, 2014; 3(3): 107-113 Published online Aug 6, 2014. doi: 10.5527/wjn.v3.i3.107
Table 1 Demographic characteristics of transplant patients between Group 1 (with ketoconazole) and Group 2 (without ketoconazole)
Group 1(n = 199)
Group 2(n = 149)
P value
Age, mean ± SD (yr)
47.2 ± 13.2
48.8 ± 14.4
0.21
Gender (%)
Male
56
61
0.47
Female
44
39
Race (%)
Black
64
55
0.19
Non-black
36
45
BMI (kg/m2)
28.3 ± 5.4
27.4 ± 5.7
0.34
Peak PRA (%)
15.5 ± 25.3
13.8 ± 27.0
0.27
HLA mismatch
4.1 ± 1.4
3.9 ± 1.6
0.52
Causes of ESRD (%)
0.75
Diabetes
25
31
Hypertension
38
35
Nephritis
19
15
PCKD
8
6
Others
10
13
Induction (%)
55
51
0.51
Donors (%)
0.63
Living
26
29
Deceased
74
71
CIT (h)
17.8 ± 7.2
18.5 ± 6.4
0.24
Table 2 Tacrolimus dose, trough level and kidney function in the two groups
1 wk
1 mo
2 mo
1 yr
3 yr
5 yr
Tacrolimus dose (mg/d)
Group 1
10.9 ± 5.6
7.5 ± 4.8
6.0 ± 3.6
5.6 ± 3.8
5.3 ± 3.1
4.9 ± 2.8
Group 2
8.6 ± 4.1
8.3 ± 3.7
8.1 ± 3.2
7.8 ± 3.0
7.0 ± 2.2
6.2 ± 2.5
P value
0.004
0.03
< 0.001
< 0.001
< 0.001
< 0.001
Tacrolimus trough level (× 10 mg/L)
Group 1
11.3 ± 2.1
9.7 ± 1.9
9.3 ± 1.7
8.6 ± 2.1
6.4 ± 1.9
5.3 ± 1.4
Group 2
10.7 ± 1.8
10.2 ± 2.0
9.5 ± 1.6
9.0 ± 1.8
5.8 ± 1.7
4.8 ± 1.5
Serum Cr (× 10 mg/L)
Group 1
2.2 ± 1.3
1.7 ± 1.1
1.5 ± 0.9
1.6 ± 1.2
1.6 ± 0.8
1.7 ± 0.9
Group 2
1.9 ± 1.1
1.7 ± 0.9
1.6 ± 0.7
1.5 ± 0.8
1.5 ± 0.7
1.6 ± 0.8
Table 3 Post transplant events and causes of graft loss and patient death
Group 1(n = 199)
Group 2(n = 149)
P value
Posttransplant events, n (%)
Delayed graft function
56 (28)
39 (26)
0.77
Acute rejection
68 (34)
27 (18)
0.01
Type of rejection
0.49
Cellular rejection
49
17
Antibody rejection
14
6
Both rejections
5
4
CNI toxicity
8 (4)
15 (10)
0.09
Infectious diseases
63 (32)
54 (36)
0.37
Type of infection
0.67
CMV
32
22
BKV
14
13
HSV
5
6
Bacteria
7
10
Fungus
5
3
Total graft loss, n (%)
52 (26)
35 (23)
0.57
Causes of graft loss
0.88
DWFG
22
16
CAN
17
10
Rejection
9
5
Infection
2
3
Others
2
1
Total patient death, n (%)
27 (14)
18 (12)
0.68
Causes of death
0.88
CVD
14
10
Infections
6
5
Malignancy
2
2
Others
3
1
Table 4 Multivariable analysis of risk factors for acute rejection
Hazard ratio
95%CI
P value
Race (black vs non-black )
2.68
1.67-6.73
0.032
Donor (living vs deceased)
0.32
0.11-0.94
0.038
Ketoconazole (yes vs no)
2.33
1.33-4.07
0.003
Delayed graft function (yes vs no)
2.14
1.22-3.73
0.008
Infection (yes vs no)
1.89
1.04-3.48
0.038
Tacrolimus dose (mg/d) in 2nd month
0.89
0.75-0.96
0.041
Citation: Khan E, Killackey M, Kumbala D, LaGuardia H, Liu YJ, Qin HZ, Alper B, Paramesh A, Buell J, Zhang R. Long-term outcome of ketoconazole and tacrolimus co-administration in kidney transplant patients. World J Nephrol 2014; 3(3): 107-113