Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2020 Apr;34(4):e13844.
doi: 10.1111/ctr.13844. Epub 2020 Mar 16.

Preliminary assessment of safety and adherence to a once-daily immunosuppression regimen in kidney transplantation: Results of a randomized controlled pilot study

David J Taber  1 , Aurora Posadas-Salas  2 , Zemin Su  3 , Vinaya Rao  2 , Vinayak Rohan  1 , Satish Nadig  1 , John W McGillicuddy  1 , Derek Dubay  1 , James N Fleming  4
Affiliations
Randomized Controlled Trial

Preliminary assessment of safety and adherence to a once-daily immunosuppression regimen in kidney transplantation: Results of a randomized controlled pilot study

David J Taber et al. Clin Transplant. 2020 Apr.

Abstract

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.

Keywords: graft survival; immunosuppressant; rejection.

PubMed Disclaimer

References

REFERENCES

    1. Denhaerynck K, Dobbels F, Cleemput I, et al. Prevalence, consequences, and determinants of nonadherence in adult renal transplant patients: a literature review. Trans Int. 2005;18:1121-1133.
    1. Chisholm MA, Vollenweider LJ, Mulloy LL, et al. Renal transplant patient compliance with free immunosuppressive medications. Transplantation. 2000;70:1240.
    1. Sellares J, De Freitas DG, Mengel M, et al. Understanding the causes of kidney transplant failure: the dominant role of antibody-mediated rejection and nonadherence. Am J Transplant. 2012;12:388-399.
    1. Fine RN, Becker Y, De Geest S, et al. Nonadherence consensus conference summary report. Am J Transplant. 2009;9:35-41.
    1. Muduma G, Shupo FC, Dam S, et al. Patient survey to identify reasons for non-adherence and elicitation of quality of life concepts associated with immunosuppressant therapy in kidney transplant recipients. Patient Prefer Adherence. 2016;10:27-36.

Publication types

LinkOut - more resources