Table 1.
Participant characteristicsa
| Development dataset |
Validation dataset |
Overall | |
|---|---|---|---|
| Number of participants | 34 | 22 | 56 |
| Sex (female/male, % male) | 14/20 (59%) | 7/15 (68%) | 21/35 (63%) |
| Recipients’ age (year) | 63 (28 – 72) | 58 (26 – 73) | 62 (26 – 73) |
| Adjusted ideal body weight (kg) | 70.6 (44.3 – 88.8) | 71.2 (44.4 – 93.4) | 70.7 (44.3 – 93.4) |
| Height (cm) | 172 (149 – 184) | 173 (147 – 194) | 172 (147 – 194) |
| Body surface area (m2) | 1.96 (1.40 – 2.60) | 1.95 (1.50 – 2.47) | 1.95 (1.40 – 2.60) |
| Donor type (related/unrelated, % related) | 6/28 (18%) | 5/17 (23%)b | 11/45 (20%) |
| Female donor to male recipient | 7 (21%) | 8 (36%) | 15 (27%) |
| Kahl relapse risk | |||
| Low | 13 (38%) | 6 (27%) | 19 (34%) |
| Standard | 13 (38%) | 13 (59%) | 26 (46%) |
| High | 8 (24%) | 3 (14%) | 11 (20%) |
| Covariates associated with MPA clearance | |||
| Concomitant calcineurin inhibitorc | |||
| Cyclosporine | 25 (74%) | 18 (82%) | 43 (77%) |
| Tacrolimus | 9 (26%) | 4 (18%) | 13 (23%) |
| Serum creatinine (mg/dL) | 1.1 (0.6 – 2.0) | 1.2 (0.7 – 2.2) | 1.1 (0.6 – 2.2) |
| Serum albumin (g/dL) | 3.4 (2.1 – 4.2) | 3.5 (2.4 – 4.1) | 3.4 (2.1 – 4.2) |
| Pharmacokinetic sampling around morning MMF dose on day +21d | |||
| Before and 1, 2, 2.5, 6 he | 29 (85%) | 0 | 29 (52%) |
| Before and 1.25, 2, 3, 4 hf | 5 (15%) | 22 (100%) | 27 (48%) |
| Day +28 donor T-cell chimerism | 85% (35–100) | 95% (61–100) | 89% (35–100) |
a
Categorical data presented as number (percentage) of participants meeting stated criteria; continuous data presented as median (min–max);
b
three patients (one related, two unrelated donor) had antigen-level mismatch;
c
concomitant sirolimus in eight cyclosporine and three tacrolimus patients (see Patient Characteristics in Methods);
d
modified to improve patient adherence (see Sample Collection in Methods),
e
November 2008 – March 2011
f
April 2011 – February 2012.