Abstract: FR-PO1046
EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study
Session Information
- Transplantation: Clinical - Pharmacology and Nonkidney Solid Organ Transplants
November 07, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Transplantation
- 2102 Transplantation: Clinical
Authors
- Mottl, Amy K., The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
- Kelley, Sara, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
- Kotzen, Elizabeth, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
- Srivastava, Anand, University of Illinois Chicago, Chicago, Illinois, United States
- Detwiler, Randal K., The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
- Roy-Chaudhury, Prabir, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Background
Despite excellent 1-year graft survival for kidney transplant recipients (KTRs) there is an important unmet clinical need for new therapies to reduce long term graft loss. Several new therapies have been shown to reduce CKD progression in non-transplant settings. In this regard, finerenone is an oral nonsteroidal mineralocorticoid receptor antagonist (ns-MRA) currently approved by the FDA for patients with CKD and T2D. We report herein on the clinical trial design of EFFEKTOR, a phase 2, double-blind clinical trial to evaluate the feasibility, safety and efficacy of finerenone in KTRs.
Methods
150 KTRs will be enrolled with a 2:1 randomization to finerenone or placebo over 12 months with an off-treatment study visit one month after stopping treatment. Inclusion criteria include age ≥18yrs, ≥6m post kidney transplant, eGFR≥25ml/min per1.7m2 and UACR≥30mg/g. Exclusion criteria include a non-renal solid organ transplant, potassium >5.0mg/dl, UACR>3500mg/g at screening, or an indication for steroidal MRA. The visit scheme is summarized in the figure. The primary outcome is feasibility, defined as the time to enroll 20% of the cohort. Secondary endpoints include safety and efficacy (relative mean change in UACR and incidence of heart failure (HF)). Biopsy and functional MRI (fMRI) sub-studies will assess impacts on pathology, tissue biomarkers, renal blood flow, fibrosis, and oxygenation.
Results
25 participants have been randomized to date with participants also enrolled in the biopsy and fMRI sub-studies. While the enrollment rate has been steady, it has also been slower than expected and additional sites were included. The major barrier to enrollment is the UACR criterion. There have been no hospitalizations due to hyperkalemia.
Conclusion
EFFEKTOR aims to bring the potential benefits of finerenone to KTRs. By determining the safety and efficacy of finerenone to improve UACR and reduce HF in KTRs, this study will inform the design of larger trial powered to address clinical endpoints and long term kidney survival.
Funding
- Commercial Support – Bayer Healthcare