Background
Methods
Patients
Immunosuppression protocol
Diagnosis of rejection
Definition of infection
Statistical analysis
Results
Baseline clinical characteristics
Low dose MMF | Conventional dose MMF | p1a
| p2b
| ||
---|---|---|---|---|---|
Rituximab(+) | Rituximab(+) | Rituximab(−) | |||
Group 1 (n = 72) | Group 2 (n = 67) | Group 3 (n = 87) | |||
Sex (male/female) | 34/38 | 42/25 | 46/41 | 0.088 | 0.526 |
Age (years) | 40.92 ± 10.20 | 44.88 ± 11.65 | 42.72 ± 10.39 | 0.034 | 0.273 |
Dialysis (hemo/peritoneal) | 50/13 | 57/6 | 54/13 | 0.134 | 1.000 |
Dialysis duration (months) | 24.95 ± 30.20 | 32.11 ± 33.47 | 31.04 ± 39.09 | 0.210 | 0.324 |
Etiology of ESRD | 0.043 | 0.006 | |||
Diabetes mellitus | 13 | 14 | 21 | ||
Hypertension | 11 | 12 | 23 | ||
Glomerulonephritis | 33 | 16 | 14 | ||
Vesicoureteral reflux | 0 | 4 | 1 | ||
Polycystic kidney disease | 3 | 5 | 5 | ||
Unknown etiology | 11 | 11 | 15 | ||
Other causes | 1 | 5 | 7 | ||
Past medical history | |||||
Diabetes mellitus | 14 | 15 | 23 | 0.682 | 0.348 |
Hypertension | 59 | 57 | 73 | 0.655 | 0.833 |
Hepatitis | 4 | 6 | 2 | 0.522 | 0.411 |
Autoimmune disease | 3 | 0 | 1 | 0.246 | 0.329 |
Malignancy history | 1 | 3 | 0 | 0.352 | 0.453 |
Mean follow up time (months) | 14.89 ± 6.01 | 12.63 ± 7.59 | 14.05 ± 8.17 | 0.053 | 0.455 |
ABO compatibility/T-flow | 0.255 | ||||
ABO incompatible | 47 | 36 | - | ||
/T-flow(−) | |||||
ABO compatible | 14 | 21 | - | ||
/T-flow(+) | |||||
ABO incompatible | 11 | 10 | - | ||
/T-flow(+) | |||||
Donor to recipient | 0.159 | ||||
Compatible | 14 | 21 | 87 | ||
A → B | 6 | 11 | - | ||
B → A | 9 | 8 | - | ||
A/B → O | 24 | 18 | - | ||
AB → A/B/O | 19 | 9 | - | ||
HLA mismatch | 3/7/13/14/10/19/6 | 4/0/7/20/7/18/11 | 4/2/12/25/14/19/11 | 0.065 | 0.335 |
(0/1/2/3/4/5/6) | |||||
HLA class I mismatch | 5/14/25/16/12 | 4/5/27/14/17 | 5/8/34/23/17 | 0.260 | 0.441 |
(0/1/2/3/4/) | |||||
HLA class II mismatch | 13/32/27 | 6/33/28 | 10/49/28 | 0.296 | 0.275 |
(0/1/2/) | |||||
Donor sex (male/female) | 39/33 | 34/33 | 46/41 | 0.735 | 0.875 |
Donor age (years) | 39.63 ± 10.95 | 41.88 ± 11.65 | 43.00 ± 9.90 | 0.241 | 0.043 |
Donor’s relation with recipient | 0.822 | 0.011 | |||
Parents | 8 | 7 | 8 | ||
Siblings | 17 | 20 | 36 | ||
Children | 14 | 11 | 6 | ||
Spouse | 27 | 21 | 22 | ||
Others | 6 | 8 | 15 | ||
CMV IgG serostatus | 0.178 | 0.590 | |||
Donor+/Recipient+ | 70 (97.2 %) | 65 (97.0 %) | 86 (98.9 %) | ||
Donor+/Recipient- | 0 (0.0 %) | 2 (3.0 %) | 0 (0 %) | ||
Donor-/Recipient+ | 2 (2.8 %) | 0 (0.0 %) | 1 (1.1 %) |
Levels and doses of immunosuppressant
Low dose MMF | Conventional dose MMF | p1a
| p2b
| ||
---|---|---|---|---|---|
Rituximab(+) | Rituximab(+) | Rituximab(−) | |||
Group 1 | Group 2 | Group 3 | |||
(n = 72) | (n = 67) | (n = 87) | |||
Tacrolimus drug levels (ng/ml) | |||||
Pre KT (72/67/87) | 6.99 ± 2.57 | 9.56 ± 4.75 | 11.11 ± 6.58 | <0.001 | <0.001 |
After 1 month (72/65/87) | 7.74 ± 3.53 | 9.17 ± 3.22 | 7.65 ± 2.89 | 0.015 | 0.847 |
After 3 months (71/55/86) | 7.19 ± 2.79 | 7.64 ± 2.54 | 7.58 ± 2.76 | 0.349 | 0.380 |
After 6 months (71/48/71) | 6.66 ± 2.50 | 7.11 ± 2.11 | 6.83 ± 2.19 | 0.304 | 0.664 |
After 1 year (49/39/48) | 5.77 ± 1.81 | 6.57 ± 2.13 | 5.77 ± 2.16 | 0.060 | 0.987 |
After 2 years (6/4/15) | 7.18 ± 1.28 | 5.48 ± 1.81 | 5.51 ± 3.16 | 0.116 | 0.228 |
Mycophenolate mofetil doses (g/day) | |||||
Pre KT (72/67/87) | 1.44 ± 0.15 | 1.51 ± 0.29 | 1.55 ± 0.17 | 0.071 | <0.001 |
After 1 week (72/66/87) | 1.03 ± 0.19 | 1.48 ± 0.34 | 1.48 ± 0.32 | <0.001 | <0.001 |
After 2 weeks (72/66/87) | 1.00 ± 0.15 | 1.42 ± 0.39 | 1.48 ± 0.31 | <0.001 | <0.001 |
After 3 weeks (72/66/87) | 1.00 ± 0.17 | 1.39 ± 0.41 | 1.46 ± 0.32 | <0.001 | <0.001 |
After 1 month (72/65/87) | 0.95 ± 0.24 | 1.26 ± 0.42 | 1.40 ± 0.39 | <0.001 | <0.001 |
After 3 months (71/55/86) | 0.93 ± 0.30 | 1.14 ± 0.51 | 1.35 ± 0.38 | 0.007 | <0.001 |
After 6 months (71/48/71) | 0.94 ± 0.26 | 1.07 ± 0.50 | 1.24 ± 0.47 | 0.095 | <0.001 |
After 1 year (49/39/47) | 0.93 ± 0.28 | 0.88 ± 0.52 | 1.23 ± 0.41 | 0.637 | <0.001 |
After 2 years (6/4/16) | 1.08 ± 0.20 | 0.69 ± 0.55 | 1.28 ± 0.45 | 0.252 | 0.313 |
Methyl-prednisolone doses (mg/day) | |||||
Pre KT (72/67/87) | 16.00 ± 0.00 | 16.84 ± 6.01 | 15.91 ± 0.86 | 0.259 | 0.365 |
After 1 month (72/65/87) | 11.11 ± 1.68 | 11.97 ± 2.31 | 11.59 ± 2.70 | 0.015 | 0.195 |
After 3 months (71/55/86) | 8.03 ± 1.49 | 9.09 ± 1.48 | 8.16 ± 2.06 | <0.001 | 0.637 |
After 6 months (71/48/71) | 6.25 ± 1.82 | 7.33 ± 1.39 | 6.87 ± 3.59 | 0.001 | 0.197 |
After 1 year (49/39/48) | 4.61 ± 1.48 | 5.33 ± 1.80 | 5.96 ± 8.71 | 0.042 | 0.289 |
After 2 years (6/4/16) | 3.00 ± 2.45 | 4.00 ± 0.00 | 3.75 ± 1.44 | 0.447 | 0.505 |
Incidence of infection
Low dose MMF | Conventional dose MMF | p1a
| p2b
| ||
---|---|---|---|---|---|
Rituximab(+) | Rituximab(+) | Rituximab(−) | |||
Group 1 (n = 72) | Group 2 (n = 67) | Group 3 (n = 87) | |||
Incidence of infection | 12 (16.7 %) | 25 (37.3 %) | 30 (34.5 %) | 0.007 | 0.012 |
Cytomegalovirus | 2 (2.8 %) | 11 (16.4 %) | 5 (5.7 %) | 0.007 | 0.458 |
BK virus | 6 (8.3 %) | 9 (13.4 %) | 11 (12.6 %) | 0.416 | 0.447 |
Urinary tract infection | 5 (6.9 %) | 6 (9.0 %) | 14 (16.1 %) | 0.758 | 0.090 |
Pneumonia | 1 (1.4 %) | 6 (9.0 %) | 4 (4.6 %) | 0.056 | 0.378 |
Sepsis | 0 (0.0 %) | 4 (6.0 %) | 2 (2.3 %) | 0.051 | 0.501 |
Graft rejection and serum creatinine levels
Low dose MMF | Conventional dose MMF | p1a
| p2b
| ||
---|---|---|---|---|---|
Rituximab(+) | Rituximab(+) | Rituximab(−) | |||
Group 1 (n = 72) | Group 2 (n = 67) | Group 3 (n = 87) | |||
Hyperacute rejection | 0 (0 %) | 0 (0 %) | 0 (0 %) | - | - |
Acute cellular rejection | 1 (1.4 %) | 3 (4.5 %) | 9 (10.3 %) | 0.352 | 0.023 |
Antibody-mediated rejection | 2 (2.8 %) | 0 (0 %) | 0 (0 %) | 0.497 | 0.203 |
Chronic rejection | 0 (0 %) | 0 (0 %) | 1 (0.6 %) | - | 1.000 |
Low dose MMF | Conventional dose MMF | p1a
| p2b
| ||
---|---|---|---|---|---|
Rituximab(+) | Rituximab(+) | Rituximab(−) | |||
Group 1 (n = 72) | Group 2 (n = 67) | Group 3 (n = 87) | |||
Pre transplantation (72/67/87) | 8.07 ± 2.82 | 8.51 ± 2.91 | 8.72 ± 3.58 | 0.371 | 0.213 |
After 1 month (72/66/87) | 1.03 ± 0.60 | 1.21 ± 1.34 | 1.03 ± 0.33 | 0.313 | 0.930 |
After 3 months (71/55/86) | 1.04 ± 0.26 | 1.17 ± 0.29 | 1.11 ± 0.30 | 0.012 | 0.153 |
After 6 months (71/48/71) | 1.08 ± 0.27 | 1.21 ± 0.31 | 1.14 ± 0.31 | 0.012 | 0.181 |
After 1 year (49/39/48) | 1.02 ± 0.26 | 1.16 ± 0.32 | 1.07 ± 0.29 | 0.033 | 0.388 |
After 2 years (6/4/15) | 1.11 ± 0.20 | 0.98 ± 0.21 | 1.35 ± 0.67 | 0.338 | 0.397 |
Incidence of malignancy and mortality
Low dose MMF | Conventional dose MMF | p1a
| p2b
| ||
---|---|---|---|---|---|
Rituximab(+) | Rituximab(+) | Rituximab(−) | |||
Group 1(n = 72) | Group 2 (n = 67) | Group 3 (n = 87) | |||
Mortality | 1 (1.4 %) | 3 (4.5 %) | 1 (1.1 %) | 0.237 | 0.961 |
Graft failure | 0 (0 %) | 1 (1.5 %) | 0 (0 %) | 0.482 | - |
Malignancy | 0 (0 %) | 2 (3.0 %) | 1 (1.1 %) | 0.231 | 1.000 |