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When serious complications have resulted in limited use of cytolytic induction therapies, in non-induction tacrolimus (FK 506) and micro-emulsion cyclosporine (Neoral) protocols, acute rejection remains in excess of 15% in kidney transplantation. This study sought to compare the efficacy of single dose OKT-3 induction and non-induction regimens in kidney transplant recipients treated with FK506/Neoral based immunosuppression.
From a pool of 158 patients transplanted consecutively between 1/96 and 12/97, 124 patients were prospectively followed for a minimum of 12 months. Patients were excluded if they were recipients of prior organ transplants (n=8), multi-organ transplants (n=6), and developed post-operative acute tubular necrosis (n=20) requiring cytolytic antibody therapy. All patients received either FK 506 or Neoral as the primary immuno-therapy. All patients received prophylactic oral ganciclovir (500 mg bid for 3 months). Group A (n=49) all cadaveric, received single dose (5 mg) of intra-operative intravenous OKT-3; Group B (n=29) all cadaveric, received no antibody induction; and Group C (n=46) all living related, received no antibody induction.
Patients were followed for episodes of biopsy proven acute rejection within 6 months post-transplant and patient - graft survival within 12 months post-transplant. As expected, compared to Groups A and B, Group C had the least HLA mismatches, cold ischemia times, and %PRA. Other demographic characteristics (Group A vs. B vs. C) including donor age (31.8 ± 2.2 vs.30.8±3.2 vs.38.4±1.6 yr.), patient age (45.4±2.3 vs.50.7±2.4 vs.36.9±2.5 yr.),% male (63 vs. 72 vs. 48), % Caucasian (84 vs. 90 vs. 91), CMV status, and causes of renal failure were comparable.
| Group A | Group B | Group C | |
| N | 49 | 29 | 46 |
| Acute rejection % | 4 (2/49)* | 24 (7/29) | 15.2 (7/46) |
| steroid resistant % | 0 (0/2) | 57 (4/7) | 71 (5/7) |
| Infection - bacterial/viral (%) | 14.3/6** | 24.1/13.8 | 26.1/19.6 |
| 1-yr S Cr. (mg/dl) | 1.47± 0.1 | 1.47±0.1 | 1.52±0.1 |
| 1-yr graft survival (%) | 93.9 | 93.1 | 96.6 |
| 1-yr patient survival (%) | 93.9 | 93.1 | 100 |
*p <0.02 ( A vs. B & C) **p<0.05 (A vs. B &C)
Our results show that, when compared with single-dose OKT-3 induced cadaveric transplant patients, episodes of acute rejection and infectious complications are significantly higher in non-induced cadaveric recipients and better HLA matched living related recipients. We conclude that single dose intra-operative OKT-3 administration is a novel approach, which allows significant reduction in early post-transplant acute rejection in recipients of kidney transplants and is well tolerated.