A Naturalistic Study of De Novo Extended-Release Tacrolimus Tablets vs. Tacrolimus Immediate-Release Capsules in Kidney Transplant Recipients

T. A. Horwedel¹, C. E. Carthon¹, S. E. January¹, A. Gharabagi¹, R. Delos Santos², J. C. Hagopian¹

¹Pharmacy, Barnes-Jewish Hospital, Saint Louis, MO, ²Nephrology, Washington University School of Medicine, Saint Louis, MO

Meeting: 2019 American Transplant Congress

Abstract number: A259

Keywords: Immunosuppression, Kidney transplantation

Session Information

Session Name: Poster Session A: Kidney Immunosuppression: Novel Regimens and Drug Minimization

Session Type: Poster Session

Date: Saturday, June 1, 2019

Session Time: 5:30pm-7:30pm

Presentation Time: 5:30pm-7:30pm

Location: Hall C & D

*Purpose: Beginning in December 2015, our center instituted a protocol change moving to de novo use of LCPT. The objective of this study is to compare the efficacy and safety of de novo LCPT use compared to historical Tac-IR use in kidney transplant recipients.

*Methods: Eligible patients received a kidney transplant alone at Barnes-Jewish Hospital between January 1, 2015 and June 30, 2017 and were maintained on tacrolimus therapy. Patients who experienced graft loss prior to 1-month or changed formulations of tacrolimus after post-operative day (POD) three were excluded. Patients were divided into two groups based on the formulation selected on post op day three. The determination of which agent to use was made at physician discretion, but following market availability on December 6, 2015, insurance coverage dictated selection of tacrolimus formulation. The primary endpoint was defined as a composite of death, graft loss, or biopsy-proven acute rejection within the first post-transplant year. Acute rejection was defined as either antibody-mediated rejection (AMR) or acute cellular rejection (ACR) graded as 1B or greater according to the contemporary Banff criteria at the time of the biopsy. The composite endpoint was assessed in a Cox proportional hazards model with a multivariable analysis including induction therapy and high risk characteristics (defined as peak PRA > 20%, African American race, prior transplant, or positive crossmatch) in the final model.

*Results: A total of 579 kidney transplants were performed between January 2015 and June 2017 and 440 were included in this study. Average tacrolimus doses at each timepoint are shown below.

Tacrolimus Doses (mg/day) at each timepoint
	Tac-IR	LCPT	p value
1 month	7.6	6.4	0.001
3 months	6.4	4.9	<0.001
6 months	5.9	4.2	<0.001
9 months	5.4	3.9	<0.001
12 months	5.2	3.6	<0.001

In total 21 patients (4.8%) experienced the primary endpoint which occurred in 11 (5.2%) of patients in the Tac-IR arm and 10 (4.4%) patients in the LCPT arm (p = 0.824) . There were no differences in any of the components of the composite primary endpoint. Renal function was similar amongst the groups at all time points.

*Conclusions: In de novo kidney transplant recipients, LCPT appears to be both safe and efficacious

To cite this abstract in AMA style:

Horwedel TA, Carthon CE, January SE, Gharabagi A, Santos RDelos, Hagopian JC. A Naturalistic Study of De Novo Extended-Release Tacrolimus Tablets vs. Tacrolimus Immediate-Release Capsules in Kidney Transplant Recipients [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/a-naturalistic-study-of-de-novo-extended-release-tacrolimus-tablets-vs-tacrolimus-immediate-release-capsules-in-kidney-transplant-recipients/. Accessed November 21, 2024.

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