Trial reportJournal of the American Society of Nephrology : JASN2026
Immunosuppression in Older Kidney Transplant Recipients: A Randomized Controlled Trial.
Trial report in Journal of the American Society of Nephrology : JASN, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03797196 (Open Label Multicenter Randomized Trial Comparing Standard Immunosuppression With Tacrolimus and Mycophenolate Mofetil With a Low Exposure Tacrolimus Regimen in Combination With Everolimus in de Novo Renal Transplantation in Elderly Patient), which is not on this map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Open Label Multicenter Randomized Trial Comparing Standard Immunosuppression With Tacrolimus and Mycophenolate Mofetil With a Low Exposure Tacrolimus Regimen in Combination With Everolimus in de Novo Renal Transplantation in Elderly Patient
Who cites it
4 citing papers in PubMed.
- Everolimus-based immunosuppression induces alloreactive regulatory T cell expansion combined with loss of alloreactive effector T cells.Frontiers in immunology · 2026Trial
- Neutral impact of mTOR inhibitors on cardiovascular outcomes after kidney transplantation.Clinical kidney journal · 2026Article
- Redefining Immunosuppression in Older Kidney Transplant Recipients: Reflections on the OPTIMIZE Study.Journal of the American Society of Nephrology : JASN · 2026Article
- Age-specific impact of different immunosuppressive regimens on kidney transplant outcomes: clinical evidence from the scientific registry of transplant recipients.Frontiers in nephrology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
key pointsLow-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.
backgroundWe 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).
methodsThe 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 µ g/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).
resultsA 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 not differ significantly. Within strata A and B, there were no significant differences in the end points.
conclusionsImmunosuppression with low-dose tacrolimus, everolimus, and prednisolone did not result in a higher rate of successful transplantation in de novo older kidney transplant recipients compared with immunosuppression with standard-dose TMP. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: ClinicalTrials.gov, NCT03797196 .
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