Table 3:
Relationship between mechanistic endpoints and composite endpoint
Mechanistic Assays | All Subjects (N=61) n (%) |
Composite Endpoint Yes (N=28) n (%) |
Composite Endpoint No (N=33) n (%) |
P-value |
---|---|---|---|---|
Pre to Post-Transplant Antibody Status | ||||
Collagen V | ||||
Neg to Neg | 10(16.4) | 7(25.0) | 3( 9.1) | 0.135 |
Neg to Pos | 21(34.4) | 8(28.6) | 13(39.4) | |
Ka1Tubulin | ||||
Neg to Neg | 3( 4.9) | 2( 7.1) | 1( 3.0) | 0.553 |
Neg to Pos | 26(42.6) | 10(35.7) | 16(48.5) | |
Donor Specific Antibody | ||||
Neg to Neg | 28(45.9) | 11(39.3) | 17(51.5) | 0.420 |
Neg to Pos | 28(45.9) | 14(50.0) | 14(42.4) | |
Post-Transplant Antibody Status | ||||
ELISA: Auto Antibodies | ||||
Collagen V | ||||
Positive | 46(75.4) | 17(60.7) | 29(87.9) | 0.038 |
Negative | 13(21.3) | 9(32.1) | 4(12.1) | |
Missing | 2( 3.3) | 2( 7.1) | 0 | NA |
Ka1Tubulin | ||||
Positive | 56(91.8) | 24(85.7) | 32(97.0) | 0.578 |
Negative | 3( 4.9) | 2( 7.1) | 1( 3.0) | |
Missing | 2( 3.3) | 2( 7.1) | 0 | NA |
Anti-HLA Antibodies | ||||
Class I | ||||
Positive | 33(54.1) | 12(42.9) | 21(63.6) | 0.179 |
Negative | 26(42.6) | 14(50.0) | 12(36.4) | |
Missing | 2( 3.3) | 2( 7.1) | 0 | NA |
Class II | ||||
Positive | 31(50.8) | 13(46.4) | 18(54.5) | 0.728 |
Negative | 28(45.9) | 13(46.4) | 15(45.5) | |
Missing | 2( 3.3) | 2( 7.1) | 0 | NA |
Donor Specific Antibody | ||||
Yes | 30(49.2) | 14(50.0) | 16(48.5) | 0.795 |
No | 30(49.2) | 13(46.4) | 17(51.5) | |
ELISPOT | ||||
Pre to Post-Transplant ELISPOT Status | ||||
Donor Specific ELISPOT (>=25) | ||||
Neg to Neg | 19(31.1) | 10(35.7) | 9(27.3) | 0.433 |
Neg to Pos | 10(16.4) | 3(10.7) | 7(21.2) | |
Kα1T Specific ELISPOT (>=5) | ||||
Neg to Neg | 3( 4.9) | 1( 3.6) | 2( 6.1) | >0.999 |
Neg to Pos | 20(32.8) | 9(32.1) | 11(33.3) | |
Post-transplant Donor Specific ELISPOT (>=25) | ||||
Positive | 16(26.2) | 6(21.4) | 10(30.3) | 0.368 |
Negative | 21(34.4) | 11(39.3) | 10(30.3) | |
Post-transplant Kα1T Specific ELISPOT (>=5) | ||||
Positive | 52(85.2) | 22(78.6) | 30(90.9) | >0.999 |
Negative | 6( 9.8) | 3(10.7) | 3( 9.1) |