Related Experiment Video
Updated: Dec 18, 2025
TBase - an Integrated Electronic Health Record and Research Database for Kidney Transplant Recipients
Published on: April 13, 2021
Everolimus for BKV nephropathy in kidney transplant recipients: a prospective, controlled study
Elisabetta Bussalino1, Luigina Marsano1, Angelica Parodi1
1Nephrology, Dialysis, and Transplantation, University of Genova, and Policlinico San Martino, Largo R. Benzi 10, 16132, Genoa, Italy.
Abstract:
There is no specific therapy for polyoma BK virus nephropathy (BKVN) in kidney transplant recipients, a condition associated with poor outcomes. Everolimus showed promising antiviral effects, but data from prospective studies are limited. Therefore, we converted ten consecutive kidney transplant recipients with biopsy-proven BKVN from standard exposure Calcineurin inhibitors and Mycophenolate to Everolimus and reduced exposure Calcineurin inhibitors. Ten patients not administered Everolimus, on reduced exposure Calcineurin inhibitor and halved MPA doses served as controls. All kidney transplant recipients continued steroid therapy. Each patient underwent kidney graft biopsy, BKV replication by PCR, and de novo DSA determination. During a 3-year follow-up no graft loss occurred in kidney transplant recipients on Everolimus but it was observed in 5/10 controls (P = 0.032). eGFR improved on Everolimus and worsened in controls (between group difference + 25.6 ml/min/1.73 m2, 95% CI 10.5-40.7, P = 0.002). BKV replication declined in the Everolimus group alone (from 6.4 ± 0.8 to 3.6 ± 1.6 Log 10 genomic copies, P = 0.0001), and we found a significant inverse relationship between eGFR and BKV genomic copy changes (P = 0.022). Average Calcineurin inhibitors trough levels did not differ between the two study groups during follow-up. By multivariable Cox regression analysis, Everolimus treatment resulted the only significant predictor of survival free of a combined endpoint of graft loss and 57% eGFR reduction (P = 0.02). Kidney transplant recipients on Everolimus had a higher survival free of adverse graft outcome (log-rank test, P = 0.009). In conclusion an Everolimus-based immunosuppressive protocol with minimization of Calcineurin inhibitors and antimetabolite discontinuation effectively treated BKVN in kidney transplant recipients.
Insights
Everolimus-based immunosuppression effectively treats polyoma BK virus nephropathy (BKVN) in kidney transplant recipients, preventing graft loss and improving kidney function. This approach offers a new therapeutic strategy for BKVN, a condition with previously poor outcomes.
Area of Science:
- Nephrology
- Immunology
- Virology
Background:
- Polyoma BK virus nephropathy (BKVN) is a significant complication in kidney transplant recipients, lacking specific therapies and associated with poor graft survival.
- Everolimus has demonstrated potential antiviral properties, but robust clinical data from prospective studies are limited.
Purpose of the Study:
- To evaluate the efficacy of an Everolimus-based immunosuppressive protocol in treating biopsy-proven BKVN in kidney transplant recipients.
- To compare graft outcomes, kidney function, and BKV replication between patients treated with Everolimus and a control group.
Main Methods:
- A prospective study converted ten kidney transplant recipients with BKVN from standard immunosuppression (Calcineurin inhibitors and Mycophenolate) to Everolimus with reduced Calcineurin inhibitor exposure.
- Ten patients not receiving Everolimus, with reduced Calcineurin inhibitor and halved Mycophenolate doses, served as controls. All patients continued steroid therapy.
- Graft biopsies, BKV DNA quantification by PCR, and de novo donor-specific antibody (DSA) determination were performed. Outcomes were assessed over a 3-year follow-up.
Main Results:
- No graft loss occurred in the Everolimus group, compared to 50% graft loss in the control group (P=0.032).
- Estimated glomerular filtration rate (eGFR) improved significantly in the Everolimus group (+25.6 ml/min/1.73 m² difference, P=0.002) and BKV replication declined (P=0.0001).
- Everolimus treatment was the sole significant predictor of survival free of graft loss or a 57% eGFR reduction (P=0.02), with higher survival free of adverse graft outcomes (P=0.009).
Conclusions:
- An Everolimus-based immunosuppressive regimen, involving minimization of Calcineurin inhibitors and discontinuation of antimetabolites, effectively treats BKVN in kidney transplant recipients.
- This protocol leads to improved graft survival, enhanced kidney function, and reduced BKV viral load.
- Everolimus represents a promising therapeutic option for managing BKVN, addressing a critical unmet need in kidney transplantation.
Related Concept Videos
01:28Kidney Transplant I: Introduction
01:16Kidney Transplant III: Nursing Management
01:26Extracorporeal Removal of Drugs: Continuous Renal Replacement Therapy
01:26Kidney Transplant II: Surgical Procedure
01:30Acute Kidney Injury IV: Diagnostic Studies and Prevention
01:15Renal Drug Excretion: Overview
A nephron consists of two primary structures: the renal corpuscle and the renal tubule. The renal corpuscle contains the glomerulus, a network of capillaries where the first step of renal excretion, glomerular filtration, occurs. Blood pressure forces water, ions, and small molecules...