Schnitzbauer, Andreas A. and Sothmann, Johannes and Baier, Lucia and Bein, Thomas and Geissler, Edward K. and Scherer, Marcus N. and Schlitt, Hans J. (2015) Calcineurin Inhibitor Free De Novo Immunosuppression in Liver Transplant Recipients With Pretransplant Renal Impairment: Results of a Pilot Study (PATRON07). TRANSPLANTATION, 99 (12). pp. 2565-2575. ISSN 0041-1337, 1534-6080
Full text not available from this repository. (Request a copy)Abstract
Background. Renal impairment and high model of end-stage liver disease scores before liver transplantation (LT) are increasingly common. Patients and Methods. This was a single-arm, 2-step prospective trial of bottom-up calcineurin inhibitor (CNI)-free de novo immunosuppressive treatment (mycofenolate mofetil, steroids, basiliximab) with delayed introduction of sirolimus in patients with renal impairment. Primary endpoint was immunologic safety assessed by the incidence of steroid-resistant rejection within the first 30 days after liver transplantation. Results. Twenty-seven patients were included with a median age of 56 years and labMELD of 28. Baseline glomerular filtration rate was 38 (Cockroft-Gault) and 24mL/min (modification of diet in renal disease). No steroid-resistant rejections occurred within 30 days. Incidence of biopsy proven acute rejection was 18.5%. Sirolimus was started on day 10 (range, day 1 to day 48). The rate switched to CNI treatment by 1 year was 44%; 1-year overall survival was 93%. Renal function improved significantly, reflected by a Delta glomerular filtration rate of 31 mL/min from baseline to 1 year (P = 0.006). Per protocol analysis revealed freedom from CNI, but not presence of sirolimus within the first 30 days, as critical for renal recovery. Conclusions. Initial de novo CNI-free immunosuppressive bottom-up treatment is safe in selected patient groups. The critical period for relevant recovery of renal function seems to be the early period (first 30 days), independent from presence of sirolimus.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | DISEASE; MODEL; EVEROLIMUS; CONVERSION; TRIAL; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Chirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 02 May 2019 08:32 |
| Last Modified: | 02 May 2019 08:32 |
| URI: | https://pred.uni-regensburg.de/id/eprint/4332 |
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