Renal Function and Patient-Reported Outcomes in Stable Kidney Transplant Patients Following Conversion From Twice-Daily Immediate-Release Tacrolimus to Once-Daily Prolonged-Release Tacrolimus: A 12-Month Observational Study in Routine Clinical Practice in Germany (ADAGIO)

Hugo C, Weihprecht H, Banas B, Schröppel B, Jank S, Arns W, Schenker P, Rath T, Hergesell O, Feldkamp T, Hermann B, Schiffer M (2021)

Publication Type: Journal article

Publication year: 2021

Journal

Transplantation Proceedings Elsevier

DOI: 10.1016/j.transproceed.2021.01.034

Abstract

Introduction: This 12-month, noninterventional study on routine clinical practice in Germany evaluated renal function in stable kidney transplant recipients converted from immediate-release tacrolimus (IR-T) to prolonged-release tacrolimus (PR-T). Methods: Renal function was assessed in 183 patients by estimated glomerular filtration rate using the modification of diet in renal disease-4 formula. Self-reported gastrointestinal health-related quality of life, adherence, satisfaction with PR-T, suspected rejection episodes, and safety were also assessed at conversion and at 3, 6, and 12 months. Results: Conversion from IR-T to PR-T resulted in stable kidney function over 12 months, with a difference in estimated glomerular filtration rate between the first and final visits of 0.1 mL/min/1.73 m2 (95% confidence interval, −1.6, 1.8). Eight patients experienced an acute rejection episode (4.4%). At each assessment, gastrointestinal health-related quality of life was low and adherence was high. Most patients reported that they were very satisfied (69.8%) or satisfied (28.1%) with PR-T at the final visit. Among patients reporting a preference, 78.4% preferred PR-T, 2.2% preferred IR-T, and 19.4% reported no preference. The safety profile of PR-T was consistent with that previously described. Conclusion: Conversion of stable kidney transplant recipients from IR-T to PR-T provided stable kidney and graft function over 12 months (Verband Forschender Arzneimittelhersteller--registered study: NIS ADV-02).

Authors with CRIS profile

Mario Schiffer Lehrstuhl für Innere Medizin IV

Involved external institutions

Universitätsklinikum Augsburg DE Germany (DE) Universitätsklinikum Regensburg DE Germany (DE) Universitätsklinikum Ulm DE Germany (DE) KfH Kuratorium für Dialyse und Nierentransplantation e.V. DE Germany (DE) Krankenhaus Köln-Merheim - Klinikum der Universität Witten/Herdecke DE Germany (DE) Universitätsklinikum Knappschaftskrankenhaus Bochum DE Germany (DE) Westpfalz-Klinikum DE Germany (DE) Nephrologisches Zentrum Villingen-Schwenningen DE Germany (DE) Technische Universität Dresden DE Germany (DE) Universitätsklinikum Schleswig-Holstein (UKSH) DE Germany (DE) Astellas Pharma GmbH DE Germany (DE)

How to cite

APA:

Hugo, C., Weihprecht, H., Banas, B., Schröppel, B., Jank, S., Arns, W.,... Schiffer, M. (2021). Renal Function and Patient-Reported Outcomes in Stable Kidney Transplant Patients Following Conversion From Twice-Daily Immediate-Release Tacrolimus to Once-Daily Prolonged-Release Tacrolimus: A 12-Month Observational Study in Routine Clinical Practice in Germany (ADAGIO). Transplantation Proceedings. https://doi.org/10.1016/j.transproceed.2021.01.034

MLA:

Hugo, Christian, et al. "Renal Function and Patient-Reported Outcomes in Stable Kidney Transplant Patients Following Conversion From Twice-Daily Immediate-Release Tacrolimus to Once-Daily Prolonged-Release Tacrolimus: A 12-Month Observational Study in Routine Clinical Practice in Germany (ADAGIO)." Transplantation Proceedings (2021).

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