Everolimus Does Not Increase Risk of Delayed Graft Function or Prolong Duration of Dialysis in Renal Transplantation.
1Univ of Utah, Salt Lake City
2Univ of Southern California, Los Angeles
3Barnabas Health, West Orange
4Novartis, East Hanover
5California Pacific Medical Center, San Francisco
6Vanderbilt Univ Medical Center, Nashville
Meeting: 2017 American Transplant Congress
Abstract number: D64
Keywords: Graft function, Kidney transplantation
Session Information
Session Name: Poster Session D: Kidney Immunosuppression: Novel Regimens and Drug Minimization
Session Type: Poster Session
Date: Tuesday, May 2, 2017
Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-7:00pm
Location: Hall D1
US92 (NCT01025817) is a phase III, 12 month, open-label, randomized study comparing everolimus (EVR) plus low-dose tacrolimus (LTac) vs. mycophenolate mofetil (MMF) with standard-dose tacrolimus (STac) in renal transplant recipients (RTxR). A post-hoc analysis investigated the influence of delayed graft function (DGF) on renal function and duration of dialysis (DoD) defined as dialysis need in the first week post-transplant in both treatment arms.
Adult (18-70 years) de novo RTxR (n=613) were randomized 1:1 to receive EVR (0.75 mg BID, adjusted to maintain trough blood level (C0h) 3–8 ng/mL) with LTac (C0h 0–2 Months [M]: 4–7 ng/mL, 2–6M: 3–6 ng/mL, 6–12M: 2–5 ng/mL) ± corticosteroids (CS) or MMF (1 g BID) with STac (C0h 0–2M: 8–12 ng/mL, 2–6M: 7–10 ng/mL, 6–12M: 5–8 ng/mL) ± corticosteroids (CS).
The incidence of DGF was similar in both treatment arms, with 13.9% of EVR- and 13.8% of MMF-treated patients experiencing DGF. Mean DoD was also similar for both treatment arms with DGF and was 6.0 ± 7.3 days for the EVR-treated patients (n = 39) versus 5.1 ± 9.1 days for MMF-treated patients (n = 36), (p= 0.63). At 12 months post-transplantation, renal function was comparable for both treatments arms, independent of DGF status (Table 1). eGFR at 12 months for patients with DGF was higher for EVR+LTac (61.4 ± 23.7mL/min/1.73m2) compared to MMF+STac (56.0 ± 20.0mL/min/1.73m2), but did not reach statistical significance. In patients who experienced DGF, the incidence of biopsy-proven acute rejection (BPAR) was similar with 6/43 (14.0%) for EVR+LTac and 5/42 (11.9%) for MMF+STac (p=0.78).
Table 1
| EVR+LTac | MMF+STac | |||||
| DGF, N | n | eGFR* | DGF, N | n | eGFR* | P value |
| Yes, 43 | 34 | 61.4 ± 23.7 | Yes, 42 | 29 | 56.0 ± 20.0 | 0.43 |
| No, 266 | 219 | 63.4 ± 21.8 | No, 262 | 219 | 64.0 ± 19.3 | 0.65 |
*(mL/min/1.73m2) at 12 months (mean ± standard deviation)
EVR did not increase the risk of DGF. In those patients with DGF, DoD and BPAR were similar in both treatment arms. In addition, renal function was comparable 12 months post-transplantation, irrespective of DGF.
CITATION INFORMATION: Shihab F, Qazi Y, Mulgaonkar S, McCague K, Patel D, Peddi V, Shaffer D. Everolimus Does Not Increase Risk of Delayed Graft Function or Prolong Duration of Dialysis in Renal Transplantation. Am J Transplant. 2017;17 (suppl 3).
To cite this abstract in AMA style:
Shihab F, Qazi Y, Mulgaonkar S, McCague K, Patel D, Peddi V, Shaffer D. Everolimus Does Not Increase Risk of Delayed Graft Function or Prolong Duration of Dialysis in Renal Transplantation. [abstract]. Am J Transplant. 2017; 17 (suppl 3). https://atcmeetingabstracts.com/abstract/everolimus-does-not-increase-risk-of-delayed-graft-function-or-prolong-duration-of-dialysis-in-renal-transplantation/. Accessed November 22, 2024.« Back to 2017 American Transplant Congress