| Title: |
Immunosuppression in Older Kidney Transplant Recipients:A Randomized Controlled Trial |
| Authors: |
Sanders,Jan-Stephan F; de Boer,Silke E; Jonker,Jip; Bemelman,Frederike J; Betjes,Michiel G H; de Vries,Aiko P J; Hilbrands,Luuk; Hilhorst,Marc; Kuypers,Dirk R J; Vart,Priya; van Zuilen, Arjan D; Hesselink,Dennis A; Berger,Stefan P; MS Nefrologie; Circulatory Health |
| Publication Year: |
2026 |
| Subject Terms: |
clinical trial; immunosuppression; kidney transplantation; survival analysis; tacrolimus; Epidemiology; Critical Care and Intensive Care Medicine; Nephrology; Transplantation; Journal Article |
| Description: |
Low-dose tacrolimus, everolimus, and prednisolone did not result in a higher rate of successful transplantation in older kidney transplant recipients. Low-dose tacrolimus, everolimus, and prednisolone did not result in better kidney function or fewer infections in older kidney transplant recipients. Background – We hypothesized that older kidney transplant recipients receiving low-dose tacrolimus, everolimus, and prednisolone (TEP) have better outcomes than patients receiving standard-dose tacrolimus, mycophenolate mofetil, and prednisolone (TMP).Methods – The OPTIMIZE study was a randomized clinical trial in kidney transplant recipients age ≥65 years. Patients receiving a kidney from a deceased donor older than 65 years (stratum A), or a kidney from a deceased donor younger than 65 years or a living donor (stratum B) were included. Patients were randomized to TEP or TMP groups. Tacrolimus target trough levels in the TEP group were 5–7 ng/ml until 3 months, 2–4 ng/ml from 3 to 6 months, and 1.5–4 ng/ml from 6 months onwards. Tacrolimus target trough levels in the TMP group were 8–12, 6–10, and 5–8 ng/ml. Everolimus target trough levels were 3–6 µg/L. The primary end point of successful transplantation was defined as being alive with a functioning graft with an eGFR above a predefined threshold at 2 years after transplantation. Predefined eGFR thresholds were 30 (stratum A) or 45 ml/min per 1.73 m 2 (stratum B).Results – A total of 379 patients were randomized, of whom 198 were in stratum A (TEP 97, TMP 101) and 181 in stratum B (TEP 90, TMP 91). The median trough levels for everolimus and tacrolimus were within the target range throughout the study. There was no statistically significant difference in successful transplantation at 2 years between the groups (TEP 94 [50%], TMP 110 [57%]; difference 7% [95% confidence interval, −17 to 3] P = 0.91). Regarding the predefined secondary outcomes, patient survival (TEP 167 [89%], TMP 171 [89%]; P = 0.95) and graft survival (TEP 155 [83%], TMP 162 [84%]; P = 0.65) did ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| ISSN: |
1046-6673 |
| Relation: |
https://dspace.library.uu.nl/handle/1874/483783 |
| Availability: |
https://dspace.library.uu.nl/handle/1874/483783 |
| Rights: |
info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.4F13457A |
| Database: |
BASE |