Long-Term Efficacy and Safety of an EVR- Vs. an MMF-Based Regimen After Pediatric Kidney Transplantation (KTX): A Case-Control Study Within the CERTAIN Registry
1Pediatric Nephrology, Hannover Medical School, Hannover, NDS, Germany
2Pediatric Nephrology, University Children's Hospital, Heidelberg, BW, Germany
3Pediatric Nephrology, Olgahospital, Stuttgart, BW, Germany.
Meeting: 2015 American Transplant Congress
Abstract number: 130
Keywords: Kidney transplantation, Pediatric
Session Information
Session Name: Concurrent Session: Pediatric Kidney Transplantation
Session Type: Concurrent Session
Date: Sunday, May 3, 2015
Session Time: 4:00pm-5:30pm
Presentation Time: 5:00pm-5:12pm
Location: Room 119-A
Background: Only short-term trials using everolimus (EVR) in children after KTX have been published. Hereby we present 4 year data on low-dose ciclosporin A (CsA), EVR and steroid elimination 8-10 months post-KTX compared to matched pairs treated with a standard immunosuppressive regimen consisting of a calcineurin inhibitor (CNI), mycophenolate mofetil (MMF) and steroids.
Methods: 35 children (median age 10.7±5.6 yr.) received basiliximab induction, CsA and prednisolone after KTX. EVR (1.6 mg/m2 per day) was added 2 weeks posttransplant combined with CsA (target trough level 40-70 ¯o;g/L). These patients were 1:2 matched to 70 patients (median age 9.8±5.4 yr.) from the CERTAIN Registry, transplanted in the same period. 12 patients received CsA + MMF, 63 tacrolimus + MMF ± basiliximab (n=5). Matching criteria were age at Tx, living-related donation, preemptive Tx and gender.
Results: Patient and graft survival were 100% and 100% (EVR) vs. 98.5% and 98.5% (controls). The median eGFR at 1 to 4 years post-Tx was 62, 61, 58 and 65 ml/min/1.73 m2 (EVR) as compared to 70, 68, 63 and 63 (controls) (n.s.). Acute rejection (BANFF ≥ Ia) in the 1st year posttransplant was diagnosed in 6% (EVR) vs. 13% (controls) (P=0.23). Steroids were withdrawn in 83% and 38% of the children within the 1st year. EVR was not discontinued in any patient, while MMF was permanently stopped in 18% of the controls. Donor-specific antibodies were found in 11% vs. 33% (P=0.03) with the diagnosis of chronic antibody-mediated rejection in 3% and 2%. One child in both groups developed EBV-associated PTLD, successfully treated with rituximab. CMV infections were diagnosed in 3% vs. 5%, BKV infections in 0.3% vs. 20% (p=0.02). The rate of unscheduled hospitalizations during 4 years post-Tx was 3.4 per patient (EVR) and 2.7 (controls, n.s.). Growth and Albuminuria were comparable (height SDS -1.05/-0.94, U-Alb:U-Krea 8±5/12±31 mg/mmol, p=0.31, 0.23) 4 years after Tx (EVR/controls).
Conclusions: This case-control study suggests that a treatment regimen consisting of basiliximab, low-dose CsA, EVR, and withdrawal of steroids yields comparable mid-term results as a standard regimen with CNI and MMF associated with a lower number of DSA and BKV-infections.
To cite this abstract in AMA style:
Pape L, Ahlenstiel-Grunow T, Hoecker B, Bald M, Kruppka K, Toenshoff B, Brunkhorst L. Long-Term Efficacy and Safety of an EVR- Vs. an MMF-Based Regimen After Pediatric Kidney Transplantation (KTX): A Case-Control Study Within the CERTAIN Registry [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/long-term-efficacy-and-safety-of-an-evr-vs-an-mmf-based-regimen-after-pediatric-kidney-transplantation-ktx-a-case-control-study-within-the-certain-registry/. Accessed May 11, 2025.« Back to 2015 American Transplant Congress