Preliminary assessment of safety and adherence to a once-daily immunosuppression regimen in kidney transplantation: Results of a randomized controlled pilot study
Medication non-adherence is common after transplant and a major contributor to graft loss. The objective of this pilot study was to obtain preliminary safety and adherence data of a complete once-daily immunosuppression regimen of Extended-release-tacrolimus (LCP-tac), everolimus, and prednisone vs LCP-tac, mycophenolate Twice daily (BID), and prednisone through a randomized controlled pilot study of 40 patients (20 in each arm). At 3 ± 2 months post-transplant, patients were randomized to receive LCP-tac and everolimus once daily or LCP-tac and mycophenolate BID (control arm) for 6 months; 80 met eligibility, and 40 were randomized. Mean age was 51 ± 14 years, 33% were female, 45% African American, and 55% had a Calculated panel reactive antibody (cPRA) >20%. Both regimens were well-tolerated, and medication side effect burden tended to be less severe in the intervention group. Self-reported high medication adherence decreased in the control arm from baseline to 6 months (80%-59%), while remaining the same in the intervention arm throughout the study (45%-47%). For safety assessment, there was no rejection, graft loss, or death in either arm. These results provide preliminary evidence of the safety of a novel once-daily immunosuppression regimen. The impact of this once-daily regimen on medication adherence requires a larger long-term study.
Reviewer: | Dr Liset Pengel, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford |
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Conclusion: | The pilot, single-centre, open-label randomised controlled trial aimed to provide preliminary safety, tolerability and adherence data for a once-daily regimen of LCP-tacrolimus and everolimus compared with standard regimen of LCP-tacrolimus and twice-daily mycophenolate in adult kidney transplant recipients. Forty patients were randomised at 3 months posttransplant and all completed the 6-month follow up. Groups were similar at baseline. These preliminary and short-term data showed that there were no differences in adverse events or clinical outcomes (acute rejection, graft loss or death) between the groups at 6 months. Tolerability was measured using side-effect burden and quality of life and both measures did not show any differences between groups at 6 months. Adherence was also not significantly different at 6 months. |
Jadad score | 2 |
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Allocation concealment | NO |
Data analysis | PER PROTOCOL |
Aims: | The aim of this randomized pilot study was to evaluate the safety and adherence to a novel immunosuppression regimen of extended release-tacrolimus (LCP-tac), everolimus and prednisone, administered once-daily, in kidney transplant recipients. |
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Interventions: | Patients were randomized 1:1 to receive LCP-tac, everolimus, and prednisone or LCP-tac, mycophenolate Twice daily (BID), and prednisone. |
Participants: | 40 adult kidney transplant recipients. |
Outcomes: | The adherence outcome was measured as the estimated change in self-reported medication adherence from baseline to 6 months. The safety outcome was the analysis of treatment failure. The tolerability outcomes were the change in self-reported side effect burden, change in quality of life (QOL) and severe adverse events. |
Follow Up: | 6 months |
Funding: | Industry funding |
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Publication type: | Randomized Controlled Trial, Randomised Controlled Trial |
Trial registration: | ClinicalTrials.gov - NCT02954198 |
Organ: | Kidney |
Language: | English |
Author email: | taberd@musc.edu |
MeSH terms: | Adult; Aged; Drug Administration Schedule; Female; Graft Rejection; Humans; Immunosuppression Therapy; Immunosuppressive Agents; Kidney Transplantation; Male; Middle Aged; Pilot Projects; Tacrolimus; 0 (Immunosuppressive Agents); WM0HAQ4WNM (Tacrolimus) |