2-Year Results of a Naturalistic Study of De Novo Extended-Release Tacrolimus Tablets vs. Tacrolimus Immediate-Release Capsules in Kidney Transplant Recipients
1Barnes-Jewish Hospital, Saint Louis, MO, 2Veloxis Pharmaceuticals, Cary, NC, 3Washington University, Saint Louis, MO
Meeting: 2020 American Transplant Congress
Abstract number: C-120
Keywords: Immunosuppression, Kidney transplantation
Session Information
Session Name: Poster Session C: Kidney Immunosuppression: Novel Regimens and Drug Minimization
Session Type: Poster Session
Date: Saturday, May 30, 2020
Session Time: 3:15pm-4:00pm
Presentation Time: 3:30pm-4:00pm
Location: Virtual
*Purpose: In December 2015, our center instituted a protocol change moving to de novo use of tacrolimus-XR (LCPT). The objective of this extension study is to compare 2-year efficacy outcomes of de novo LCPT compared to tacrolimus-IR (Tac-IR) in kidney transplant (KT) recipients.
*Methods: Patients received a solitary KT between 1/1/15 and 6/30/17 and were maintained on tacrolimus (tac) therapy. Patients who experienced graft loss before 1 month or changed tac formulations after post-operative day (POD) 3 were excluded. Patients were divided into two groups based upon tac formulation on POD3. Choice of agent was dictated by insurance coverage between the tac formulations. The primary endpoint was defined as composite of death, graft loss, or biopsy-proven acute rejection within two years post-KT. Acute rejection was defined as either AMR or ACR Banff grades borderline through 3. Differences in the composite endpoint or their components were evaluated via chi-square analysis. Associations with the composite endpoint were assessed using a multivariable logistic regression model.
*Results: A total of 579 KTs were performed during the study period, 440 patients were included in the analysis. Groups were well matched with differences only noted in age and peak PRA (Table 1). There were no differences in type of transplant, incidence of DGF, positive crossmatch (XM), or use of antithymocyte globulin induction between groups.
| LCPT, n=228 | Tac-IR, n=212 | p-value | |
| Age (median, IQR) | 54.4 (42.7, 63.1) | 51.1 (36.9, 62.8) | 0.02 |
| Male (n, %) | 132 (57.9) | 141 (66.5) | 0.06 |
| African American (AA) (n, %) | 70 (30.7) | 71 (33.5) | 0.53 |
| CMV D+/R- (n, %) | 42 (18.4) | 43 (20.3) | 0.60 |
| Dialysis duration before KT, months (median, IQR) | 46.2 (23.4, 72.8) | 40.9 (17.2, 67.9) | 0.57 |
| Prior KT (n, %) | 41 (18.0) | 31 (14.6) | 0.34 |
| Peak PRA >20% (n, %) | 76 (33.3) | 41 (19.3) | <0.01 |
At two years post-transplant, there were no differences in the composite endpoint in the LCPT arm compared to the Tac-IR arm (28 vs.17, p<0.01). There were no differences in any of the components of the composite endpoint. Renal function (mL/min) at 2 years post-KT was similar between the LCPT and Tac-IR arms, 61.4 ± 18.1 vs. 62.1 ± 19.2, respectively. Prior KT and peak PRA >20% were associated with the composite endpoint (Table 2).
| Risk Factor | HR (95% CI) | p-value |
| LCPT | 0.85 (0.46-1.56) | 0.60 |
| AA | 1.11 (0.59-2.09) | 0.75 |
| Prior KT | 2.63 (1.27-5.44) | 0.01 |
| Positive XM | 0.89 (0.34-2.36) | 0.82 |
| Peak PRA >20% | 2.30 (1.15-4.61) | 0.02 |
*Conclusions: At 2 years post-KT, de novo use of LCPT is an efficacious alternative to Tac-IR.
To cite this abstract in AMA style:
Hagopian J, January S, Nesselhauf N, Progar K, Horwedel T, Santos RDelos. 2-Year Results of a Naturalistic Study of De Novo Extended-Release Tacrolimus Tablets vs. Tacrolimus Immediate-Release Capsules in Kidney Transplant Recipients [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/2-year-results-of-a-naturalistic-study-of-de-novo-extended-release-tacrolimus-tablets-vs-tacrolimus-immediate-release-capsules-in-kidney-transplant-recipients/. Accessed May 10, 2025.« Back to 2020 American Transplant Congress