TRANSFORM: A Modern Approach to Evaluate Long-Term Outcomes of Everolimus with Reduced-Calcineurin Inhibitors in De Novo Kidney Transplant Recipients[mdash]Baseline Characteristics.
On behalf of the TRANSFORM Investigators, Division of Transplantation Surgery, Wexner Medical Center, The Ohio State University, Columbus, OH.
Meeting: 2016 American Transplant Congress
Abstract number: B129
Keywords: Efficacy, Immunosuppression, Kidney transplantation, Renal function
Session Information
Session Name: Poster Session B: Drug Minimization
Session Type: Poster Session
Date: Sunday, June 12, 2016
Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-7:00pm
Location: Halls C&D
Purpose: Acute rejection and poor graft function are two major risk factors for allograft failure in kidney transplant (KTx) recipients (KTxR). Although, graft survival and rejection rates have markedly improved during the first year post transplantation, maximizing long-term outcomes still remains a challenge. TRANSFORM is the first and largest prospective study recruiting >2,000 KTxR. The baseline data of KTxR randomized until June, 2015 are presented here.
Methods: TRANSFORM (NCT01950819) is an ongoing 24-month (M) randomized, multicenter, open-label, two-arm study in which adult de novo KTxR are randomized (1:1) to receive everolimus (EVR)+reduced calcineurin inhibitor (rCNI) or mycophenolic acid (MPA)+standard CNI (sCNI) along with induction and steroids. The primary objective is to evaluate the effect of EVR+rCNI versus MPA+sCNI on the binary composite endpoint of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate <50 mL/min/1.73 m2 at M12 post-KTx. The key secondary objective is to evaluate the composite efficacy failure (tBPAR, graft loss or death) at M12 and M24 post-KTx.
Results: Currently, TRANSFORM has randomized more than 1900 patients and aims to have last patient first visit by the end of December 2015. The baseline data of 1191 patients, as of June 2015 are: The recipients' mean age (SD) is 50.6 (14.4) years, mean BMI (SD) is 25.6 (4.4) kg/m2 and are majorly Caucasian (76.2%). Majority of KTxR received basiliximab (80.7%) as induction therapy. The leading causes for KTx were glomerular disease (16.0%) and polycystic disease (14.7%).
Conclusion: TRANSFORM is the first and largest trial that includes a clinically relevant primary endpoint that is a composite measurement of anti-rejection efficacy and preservation of renal function. The study will provide substantial evidence on the optimal immunosuppression that can facilitate reduction in the chronic nephrotoxic effects of the CNIs by assessing the short-term and long-term outcomes with EVR+rCNI compared with MPA+sCNI in KTxR.
CITATION INFORMATION: Henry M. TRANSFORM: A Modern Approach to Evaluate Long-Term Outcomes of Everolimus with Reduced-Calcineurin Inhibitors in De Novo Kidney Transplant Recipients[mdash]Baseline Characteristics. Am J Transplant. 2016;16 (suppl 3).
To cite this abstract in AMA style:
Henry M. TRANSFORM: A Modern Approach to Evaluate Long-Term Outcomes of Everolimus with Reduced-Calcineurin Inhibitors in De Novo Kidney Transplant Recipients[mdash]Baseline Characteristics. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/transform-a-modern-approach-to-evaluate-long-term-outcomes-of-everolimus-with-reduced-calcineurin-inhibitors-in-de-novo-kidney-transplant-recipientsmdashbaseline-characteristics/. Accessed May 9, 2025.« Back to 2016 American Transplant Congress