The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study

Summary

EFFEKTOR is a vanguard, multicenter, phase 2 randomized, double blinded, placebo controlled clinical trial to determine the feasibility, tolerability, safety, and efficacy of finerenone in kidney transplant recipients (KTRs). One hundred fifty (150) KTRs will be randomized in a 2:1 ratio of finerenone to placebo, with two embedded substudies: (i) a kidney biopsy substudy in 50 participants who undergo a research kidney biopsy prior to randomization and at the end of active treatment; and (ii) a functional MRI (fMRI) substudy in 50 participants who undergo fMRI prior to randomization and at the end of active treatment.

Timeline

Start

2024-04-23

Primary completion

2027-03-31

Completion

2027-12-31

Publications

• Background Wolfe RA, Ashby VB, Milford EL, Ojo AO, Ettenger RE, Agodoa LY, Held PJ, Port FK. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. 1999 Dec 2;341(23):1725-30. doi: 10.1056/NEJM199912023412303.
• Background Hart A, Lentine KL, Smith JM, Miller JM, Skeans MA, Prentice M, Robinson A, Foutz J, Booker SE, Israni AK, Hirose R, Snyder JJ. OPTN/SRTR 2019 Annual Data Report: Kidney. Am J Transplant. 2021 Feb;21 Suppl 2:21-137. doi: 10.1111/ajt.16502.
• Background Rangaswami J, Mathew RO, Parasuraman R, Tantisattamo E, Lubetzky M, Rao S, Yaqub MS, Birdwell KA, Bennett W, Dalal P, Kapoor R, Lerma EV, Lerman M, McCormick N, Bangalore S, McCullough PA, Dadhania DM. Cardiovascular disease in the kidney transplant recipient: epidemiology, diagnosis and management strategies. Nephrol Dial Transplant. 2019 May 1;34(5):760-773. doi: 10.1093/ndt/gfz053.
• Background Matas AJ, Humar A, Gillingham KJ, Payne WD, Gruessner RW, Kandaswamy R, Dunn DL, Najarian JS, Sutherland DE. Five preventable causes of kidney graft loss in the 1990s: a single-center analysis. Kidney Int. 2002 Aug;62(2):704-14. doi: 10.1046/j.1523-1755.2002.00491.x.
• Background Paraskevas S, Kandaswamy R, Humar A, Gillingham KJ, Gruessner RW, Payne WD, Najarian JS, Sutherland DE, Matas AJ. Risk factors for rising creatinine in renal allografts with 1 and 3 yr survival. Clin Transplant. 2006 Nov-Dec;20(6):667-72. doi: 10.1111/j.1399-0012.2006.00566.x.
• Background Morales JM, Marcen R, del Castillo D, Andres A, Gonzalez-Molina M, Oppenheimer F, Seron D, Gil-Vernet S, Lampreave I, Gainza FJ, Valdes F, Cabello M, Anaya F, Escuin F, Arias M, Pallardo L, Bustamante J. Risk factors for graft loss and mortality after renal transplantation according to recipient age: a prospective multicentre study. Nephrol Dial Transplant. 2012 Dec;27 Suppl 4(Suppl 4):iv39-46. doi: 10.1093/ndt/gfs544.
• Background Karthikeyan V, Karpinski J, Nair RC, Knoll G. The burden of chronic kidney disease in renal transplant recipients. Am J Transplant. 2004 Feb;4(2):262-9. doi: 10.1046/j.1600-6143.2003.00315.x.
• Background Knoll GA. Proteinuria in kidney transplant recipients: prevalence, prognosis, and evidence-based management. Am J Kidney Dis. 2009 Dec;54(6):1131-44. doi: 10.1053/j.ajkd.2009.06.031. Epub 2009 Sep 2.
• Background Lam NN, Tonelli M, Lentine KL, Hemmelgarn B, Ye F, Wen K, Klarenbach S. Albuminuria and posttransplant chronic kidney disease stage predict transplant outcomes. Kidney Int. 2017 Aug;92(2):470-478. doi: 10.1016/j.kint.2017.01.028. Epub 2017 Mar 31.
• Background Gaston RS, Fieberg A, Hunsicker L, Kasiske BL, Leduc R, Cosio FG, Gourishankar S, Grande J, Mannon RB, Rush D, Cecka JM, Connett J, Matas AJ. Late graft failure after kidney transplantation as the consequence of late versus early events. Am J Transplant. 2018 May;18(5):1158-1167. doi: 10.1111/ajt.14590. Epub 2017 Dec 5.
• Background Meier-Kriesche HU, Baliga R, Kaplan B. Decreased renal function is a strong risk factor for cardiovascular death after renal transplantation. Transplantation. 2003 Apr 27;75(8):1291-5. doi: 10.1097/01.TP.0000061602.03327.E2.
• Background Lenihan CR, Liu S, Deswal A, Montez-Rath ME, Winkelmayer WC. De Novo Heart Failure After Kidney Transplantation: Trends in Incidence and Outcomes. Am J Kidney Dis. 2018 Aug;72(2):223-233. doi: 10.1053/j.ajkd.2018.01.041. Epub 2018 Mar 29.
• Background Awan AA, Niu J, Pan JS, Erickson KF, Mandayam S, Winkelmayer WC, Navaneethan SD, Ramanathan V. Trends in the Causes of Death among Kidney Transplant Recipients in the United States (1996-2014). Am J Nephrol. 2018;48(6):472-481. doi: 10.1159/000495081. Epub 2018 Nov 23.
• Background Gaston RS, Fieberg A, Helgeson ES, Eversull J, Hunsicker L, Kasiske BL, Leduc R, Rush D, Matas AJ; DeKAF Investigators*. Late Graft Loss After Kidney Transplantation: Is "Death With Function" Really Death With a Functioning Allograft? Transplantation. 2020 Jul;104(7):1483-1490. doi: 10.1097/TP.0000000000002961.
• Background Ying T, Shi B, Kelly PJ, Pilmore H, Clayton PA, Chadban SJ. Death after Kidney Transplantation: An Analysis by Era and Time Post-Transplant. J Am Soc Nephrol. 2020 Dec;31(12):2887-2899. doi: 10.1681/ASN.2020050566. Epub 2020 Sep 9.
• Vinson AJ, Matas A. Late Allograft Loss and Contemporary Cardiorenal Metabolic Therapies. J Am Soc Nephrol. 2025 Apr 7;36(8):1659-1667. doi: 10.1681/ASN.0000000726.
• Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.

Drugs

Indications

No indication recorded.