Table 2.
Clinical outcomes after 60 week study period and three year follow-up. Data are numbers unless indicated otherwise
| Clinical outcome | 60 weeks | 3 years | |||||
|---|---|---|---|---|---|---|---|
| nTreg (n=11) | Reference (n=9) | P value | nTreg (n=11) | Reference (n=9) | P value | ||
| Immunosuppression | |||||||
| Monotherapy (tacrolimus only) | 8 | 0 | 0.002 | 8 | — | 0.001 | |
| Dual therapy (tacrolimus, MMF) | — | 5 | — | 4 | |||
| Triple therapy (tacrolimus, MMF, steroid) | 3 | 4 | 3 | 5 | |||
| Alloreactivity | |||||||
| T cell mediated acute rejection | 0.56 | 1.00 | |||||
| Borderline | — | 1 | — | — | |||
| Ia/Ib | 1 | 1 | — | — | |||
| IIa/IIb/III | 1 | — | — | — | |||
| Mixed T cell and antibody mediated acute rejection | 1 | — | — | — | |||
| De novo donor specific antibodies | 2 | — | 0.18 | 2 | 1 | 0.66 | |
| Infections and malignancies | |||||||
| Cytomegalovirus viraemia | 1 | 1 | 0.51 | — | — | 1.00 | |
| Cytomegalovirus disease | — | — | 1.00 | — | 1 | 0.26 | |
| Polyomavirus viraemia | — | 1 | 0.26 | — | — | 1.00 | |
| Other infections* | 1 | 1 | 0.88 | — | — | 1.00 | |
| Cancer | — | — | 1.00 | — | 1 | 0.26 | |
| Graft function | |||||||
| Delayed graft function | — | 2 | 0.10 | — | — | 1.00 | |
| Median (range) creatinine (mg/dL) | 1.6 (1.3-1.8) | 1.1 (1.0-2.0) | 0.65 | 1.5 (1.2-1.6) | 1.2 (0.9-2.0) | 0.80 | |
| Median (range) estimated glomerular filtration rate (mL/min) | 51 (46-58) | 60 (37-64) | 0.45 | 53 (47-49) | 59 (38-66) | 0.79 | |
| Median (range) proteinuria (mg/g Krea) | 192 (92-336) | 130 (93-430) | 0.89 | 120 (89-221) | 151 (62-278) | 0.89 | |
MMF=mycophenolate mofetil; nTreg=natural regulatory T cell.
nTreg and reference groups were compared after 60 weeks (study endpoint) and at three year follow-up.
*
Urinary tract infection and pneumonia.