Date: Sunday, June 12, 2016
Session Name: Concurrent Session: Kidney Transplant: CNI Minimization
Session Time: 2:30pm-4:00pm
Presentation Time: 3:06pm-3:18pm
Location: Room 311
The US92 study determined whether, in de novo renal transplant patients (pts), concentration-controlled everolimus (EVR) with reduced dose tacrolimus (RTAC) is non-inferior compared to CellCept® (mycophenolate mofetil [MMF] with standard dose tacrolimus [STAC]) on measures of allograft function and safety in low and high risk pts.
In this non-inferiority (NI) study, the safety and efficacy of EVR (1.5mg/day) with RTAC was compared to MMF (2g/day) with STAC in 613 de novo renal transplant pts. The primary efficacy variable was composite efficacy failure rate (treated biopsy-proven acute rejection [tBPAR, based on local biopsy reading], graft loss, death, or loss to follow-up) at 12 months post-transplant. Three NI margins were used in the data analysis: an updated conservative NI margin (11.2%) incorporated publications through September 2014; a less conservative NI margin (12%) preserved control effect, incorporating information about standard error of historical estimatesof the control effect and information from the NI study; and an updated less conservative NI margin (15.0%) was used in the analysis.
Low-to-moderate risk pt results for the primary efficacy variables and composite endpoints (CE) are shown in the table. One additional pt in the MMF control group considered as lost to follow-up died 4 months after randomization.
Efficacy failure in low-to-moderate immunologic risk pts at 12 months
n (%) N=213
n (%) N=210
|Difference in %||95% CI|
|Efficacy Endpoints CE1||48 (22.5)||41 (19.5)||3.0||-4.7, 10.8|
|tBPAR||39 (18.3)||24 (11.4)||6.9||0.1, 13.6|
|Graft loss||1 (0.5)||8 (3.8)||-3.3||-6.1, -0.6|
|Death||3 (1.4)||3 (1.4)||0.0||-2.3, 2.2|
|Loss to follow-up||6 (2.8)||9 (4.3)||-1.5||-5.0, 2.1|
|Graft loss or death or loss to follow-up||10 (4.7)||20 (9.5)||-4.8||-9.7, 0.1|
|Graft loss or death||4 (1.9)||11 (5.2)||-3.4||-6.9, 0.2|
Based on the NI margins of 11.2%, 12.0% and 15%, NI of EVR with RTAC compared to MMF with STAC was observed in pts at low-to-moderate immunologic risk.
EVR with RTAC was efficacious for low-to-moderate risk pts. Graft rejections in the EVR group were higher yet graft loss was statistically significantly lower in this group. No unexpected safety events were found.
CITATION INFORMATION: Qazi Y, Shihab F, Mulgaonkar S, MaCague K, Patel D. Everolimus in Combination with Reduced Dose Tacrolimus Is Effective as a Prophylaxis of Acute Rejection in Low-to-Moderate Immunologic Risk De Novo Kidney Transplantation Patients. Am J Transplant. 2016;16 (suppl 3).
To cite this abstract in AMA style:Qazi Y, Shihab F, Mulgaonkar S, MaCague K, Patel D. Everolimus in Combination with Reduced Dose Tacrolimus Is Effective as a Prophylaxis of Acute Rejection in Low-to-Moderate Immunologic Risk De Novo Kidney Transplantation Patients. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/everolimus-in-combination-with-reduced-dose-tacrolimus-is-effective-as-a-prophylaxis-of-acute-rejection-in-low-to-moderate-immunologic-risk-de-novo-kidney-transplantation-patients/. Accessed February 25, 2021.
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