Less renal allograft fibrosis with valganciclovir prophylaxis for cytomegalovirus compared to high-dose valacyclovir: a parallel group, open-label, randomized controlled trial

Table 2 Histological findings in protocol biopsy at 36 months after transplantation

Characteristic	Valganciclovir (n = 51)^a	Valacyclovir (n = 50)^a	aOR (95% CI)^b	P Value^c
Glomeruli per biopsy	10.5 ± 7.6	13.0 ± 6.0		0.004
Arteries per biopsy	1.7 ± 0.9	1.7 ± 1.1		0.903
Moderate-to-severe IFTA^d	11 (22)	17 (34)	0.31 (0.11–0.90)	0.032
IF/TA (all grades)	21 (41)	24 (48)		0.624
Chronic “ci + ct” score	1.64 ± 1.64	1.82 ± 1.59		0.529
Subclinical rejection	2 (4)	2 (4)		0.624
Borderline changes	7 (14)	3 (6)		0.334
Chronic antibody-mediated rejection	6 (12)	6 (12)		0.786
Chronic T-cell-mediated rejection	2 (4)	1 (2)		0.986
Calcineurin inhibitor toxicity	1 (2)	2 (4)		0.986
Vascular nephrosclerosis	13 (25)	14 (28)		0.952
Glomerulonephritis recurrence	2 (4)	0 (0)		0.484

Data are number of patients (percentage) or mean ± standard deviation. aOR, adjusted odds ratio; CI, confidence interval; IFTA, interstitial fibrosis and tubular atrophy; ci, interstitial fibrosis score; ct, tubular atrophy score
^aBiopsy not available in valganciclovir: 6 death or graft loss, 1 refused, 2 insufficient material; in valacyclovir: 4 death or graft loss, 1 lost to follow up, 1 technical reason, 3 insufficient material
^bAdjusted for calcineurin inhibitor, induction therapy, and advanced chronic histologic damage in donor biopsy
^cMultivariate logistic regression for moderate-to-severe IFTA comparison; chi-squared or Fisher exact test for categorical variables; Mann-Whitney U-test for continuous variables
^dGrade 2 or more according to the Banff 2013 classification

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