Clinical Study

A Prospective, Multinational Pharmacoepidemiological Study of Clinical Conversion to Sirolimus Immunosuppression after Renal Transplantation

Table 1

Demographics and baseline characteristics of subjects.

Time of conversion after transplantEarlyLateTotal

Number of subjects187297484
Number of subjects by region
 (i) North America5584139
 (ii) South America129207336
 (iii) Europe246
 (iv) Other123
Mean age (years)*45 ± 1435 ± 1539 ± 15
Gender (male)120 (64%)178 (60%)298 (62%)
Ethnicity*
 (i) Caucasian141 (75%)212 (71%)353 (73%)
 (ii) Black31 (17%)29 (10%)60 (12%)
 (iii) Hispanic12 (6%)46 (16%)58 (12%)
 (iv) Asian1 (1%)3 (1%)4 (1%)
 (v) Other2 (1%)7 (2%)9 (2%)
Primary kidney disease
 (i) Glomerulonephritis50 (27%)102 (34%)152 (31%)
 (ii) Diabetes mellitus17 (9%)17 (6%)34 (7%)
 (iii) Hypertension31 (17%)42 (14%)73 (15%)
 (iv) Polycystic kidney disease10 (5%)25 (8%)35 (7%)
Transplant number
 (i) First transplant167 (89%)273 (92%)440 (91%)
 (ii) Retransplant20 (11%)24 (8%)44 (9%)
Donor source*
 (i) Deceased donor135 (72%)132 (44%)267 (55%)
 (ii) Living donor48 (26%)162 (55%)210 (43%)
 (iii) Not reported4 (2%)3 (1%)7 (2%)
Panel reactive antibodies (%)8 ± 206 ± 167 ± 18
Time to start of sirolimus (months)3 ± 361 ± 3839 ± 41
Posttransplant followup (months)27 ± 1424 ± 1225 ± 13
Reason for commencing sirolimus
 (i) Deteriorating graft function38 (20.3%)108 (36.4%)146 (30.2%)
 (ii) Adverse effects of prior immunosuppressants55 (29.4%)89 (30.0%)144 (29.8%)
 (iii) Routine practice within centre26 (13.9%)14 (4.7%)40 (8.3%)
 (iv) Delayed graft function29 (15.5%)2 (0.7%)31 (6.4%)
 (v) Rejection on prior immunosuppression5 (2.7%)9 (3.0%)14 (2.9%)
 (vi) Contraindications to an other immunosuppression4 (2.1%)1 (0.3%)5 (1.0%)
 (vii) Other30 (16.0%)74 (24.9%)104 (21.5%)

𝑃 < 0 . 0 5 .