Table 1

Patient demographics and clinical outcome. Age, race, gender, nephrectomy of the native kidneys, time to end-stage renal disease (ESRD), and donor characteristics (living versus deceased) are shown for the 14 historical control patients who did not receive rituximab, but did receive the standard induction treatment, and 27 patients who received one dose of rituximab (375 mg/m2) within 24 hours of kidney transplant. CD19+ cells decreased significantly in rituximab-treated patients 3 days after infusion and were almost undetectable 10 days after treatment. The incidence of recurrent nephrotic-range proteinuria and the need for plasmapheresis between days 3 and 30 after transplantation were significantly lower in the rituximab group than in the control group. The changes in estimated glomerular filtration rate (ΔeGFR) at 3 and 6 months after transplant (from baseline at 1 month) were significantly higher in the control group than in the rituximab group. There was no statistically significant difference in graft survival between groups at 6 and 12 months. Fisher’s exact test was used for categorical variables race, gender, donor (LD/DD), nephrectomy (Y/N), nephrotic proteinuria, and plasmapheresis. Log-rank test was used for survival analysis (6 and 12 months). All other variables were compared with the Wilcoxon rank-sum test, and all P values result from the comparison of historical control and rituximab-treated patients. B, black; DD, deceased donor; F, female; LD, living donor; M, male; W, white.

Controls (no rituximab), n = 14Treated (rituximab), n = 27P
Age (years) (mean ± SD)12.3 ± 5.215.0 ± 5.50.17
Race (W/B)9/5 (64%/36%)14/13 (52%/48%)0.52
Gender (M/F)6/8 (43%/57%)9/18 (33%/67%)0.74
Time to ESRD (mean year ± SD)3.3 ± 2.13.4 ± 2.00.79
Donor (LD/DD)9/5 (64% LD)4/23 (15% LD)0.0033
Donor age (mean ± SD)31.3 ± 9.424.7 ± 14.60.13
Nephrectomy (Y/N)7/7 (50% Y)16/11 (59% Y)0.74
Nephrotic proteinuria within 1 month9 (64%)7 (26%)0.023
Plasmapheresis within 1 month10 (71%)8 (30%)0.019
CD19 count (mean ± SD)
  Week 0412 ± 223360 ± 2230.43
  Week 0.5327 ± 290107 ± 1150.015
  Week 1472 ± 43745 ± 31<0.00010
  Week 2559 ± 52616 ± 23<0.00010
  Week 3729 ± 6705 ± 6<0.00010
  Week 4630 ± 3846 ± 70.00020
ΔeGFR (mean versus 1-month baseline ± SD)
  3 months−18.0 ± 16.9−1.3 ± 14.60.0012
  6 months−19.0 ± 19.8−5.3 ± 18.40.0075
  12 months−26.9 ± 26.7−20.3 ± 27.30.37
Percent graft survival
  6 months92.9%100%0.17
  12 months85.7%95.8%0.26