Kidney Week

Abstract: TH-PO1155

Effect of Everolimus with Reduced-Exposure Calcineurin Inhibitor in De Novo Kidney Transplant Recipients: 24-Month Results from the US Cohort of the TRANSFORM Study

Session Information

• Late-Breaking Clinical Trials Posters
  October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Transplantation

• No subcategory defined

Authors

• Qazi, Yasir A., University of Southern California, Los Angeles, California, United States

Yasir A. Qazi,

• Kim, Dean Y., Henry Ford Hospital, Detroit, Michigan, United States

Dean Y. Kim,

• Wiseman, Alexander C., University of Colorado at Denver and Health Sciences Center, Denver, Colorado, United States

Alexander C. Wiseman,

• Peddi, V. Ram, California Pacific Medical Center, San Francisco, California, United States

V. Ram Peddi,

• Steinberg, Steven M., Balboa Nephrology Medical Group, San Diego, California, United States

Steven M. Steinberg,

• Shihab, Fuad S., University of Utah Health Science Center, Salt Lake City, Utah, United States

Fuad S. Shihab,

• Henry, Mitchell L., Ohio State University, Columbus, Ohio, United States

Mitchell L. Henry,

• Mccague, Kevin M., Novartis Pharmaceuticals Corp., E. Hanover, New Jersey, United States

Kevin M. Mccague,

• Bernhardt, Peter, Novartis Pharma AG, Basel, Switzerland

Peter Bernhardt,

• Mulgaonkar, Shamkant P., St. Barnabas Medical Center, Livingston, New Jersey, United States

Shamkant P. Mulgaonkar,

Background

To present 24-month (M) efficacy and safety data from the US cohort of the TRANSFORM study (NCT01950819).

Methods

In this 24M, multicenter, open-label study, de novo kidney transplant recipients (KTxRs) were randomized to receive either everolimus + reduced-exposure calcineurin inhibitor (EVR+rCNI: 1022) or mycophenolic acid + standard-exposure CNI (MPA+sCNI: 1015) with induction and steroids. The binary composite of tBPAR or eGFR <50 mL/min/1.73 m², composite efficacy failure (CEF: tBPAR/graft loss/death) and individual components, eGFR (MDRD4), and safety were assessed at M24.

Results

Of 2037 KTxRs in overall study, 352 (EVR+rCNI: 173; MPA+sCNI: 179) were included in the US cohort. Except for younger donors and lower proportion of extended criteria donors (ECD) in the US cohort, other characteristics were similar for both populations. Similar to the overall population, CNI trough levels (C0) were towards the upper limit/above the target C0 throughout the study. In contrast to overall population, the incidence of binary composite efficacy was significantly higher in the EVR+rCNI vs MPA+sCNI arm in the US cohort at M24. The CEF and individual components were comparable between arms in both populations (Table). Mean eGFR was higher in the US cohort vs overall population for both arms. Incidence of viral infections were lower in EVR+rCNI vs MPA+sCNI.

Conclusion

Similar to 24M data from the TRANSFORM study, US cohort showed comparable efficacy and safety with lower viral infection rates in the EVR+rCNI vs MPA+sCNI arm; higher mean eGFRs in the US cohort may be attributed to differences in donor type and age in the population.

Funding

• Commercial Support – Novartis