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Calcineurin Inhibitor

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1. Calcineurin inhibitor withdrawal or tapering for kidney transplant recipients. Full Text available with Trip Pro

Calcineurin inhibitor withdrawal or tapering for kidney transplant recipients. Calcineurin inhibitors (CNI) can reduce acute transplant rejection and immediate graft loss but are associated with significant adverse effects such as hypertension and nephrotoxicity which may contribute to chronic rejection. CNI toxicity has led to numerous studies investigating CNI withdrawal and tapering strategies. Despite this, uncertainty remains about minimisation or withdrawal of CNI.This review aimed (...) inconsistently. We also noted that 50% (47 studies) of studies were funded by the pharmaceutical industry.We classified studies into four groups: CNI withdrawal or avoidance with or without substitution with mammalian target of rapamycin inhibitors (mTOR-I); and low dose CNI with or without mTOR-I. The withdrawal groups were further stratified as avoidance and withdrawal subgroups for major outcomes.CNI withdrawal may lead to rejection (RR 2.54, 95% CI 1.56 to 4.12; moderate certainty evidence), may make

2017 Cochrane

2. Calcineurin inhibitor minimisation versus continuation of calcineurin inhibitor treatment for liver transplant recipients. (Abstract)

Calcineurin inhibitor minimisation versus continuation of calcineurin inhibitor treatment for liver transplant recipients. The therapeutic success of liver transplantation has been largely attributable to the development of effective immunosuppressive treatment regimens. In particular, calcineurin inhibitors were essential in reducing acute rejection and improving early survival. Currently, more than 90% of all liver transplant recipients are treated with the calcineurin inhibitor cyclosporine (...) or tacrolimus. Unfortunately, calcineurin inhibitors cause adverse events, such as nephrotoxicity, and because of this, minimisation (reduction and withdrawal) regimens of calcineurin inhibitor have been developed and studied. However, the benefits and harms of these minimisation regimens are unclear.To assess the benefits and harms of calcineurin inhibitor minimisation for liver transplant recipients without substitution by another immunosuppressive agent.We searched The Cochrane Hepato-Biliary Group

2012 Cochrane

3. Efficacy and safety of everolimus plus low-dose calcineurin inhibitor vs. mycophenolate mofetil plus standard-dose calcineurin inhibitor in renal transplant recipients: A systematic review and meta-analysis
. (Abstract)

Efficacy and safety of everolimus plus low-dose calcineurin inhibitor vs. mycophenolate mofetil plus standard-dose calcineurin inhibitor in renal transplant recipients: A systematic review and meta-analysis
. To seek an optimized immunotherapy which can preserve renal function while maintaining low acute rejection rates, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of everolimus (EVR) plus low-dose calcineurin (...) inhibitor (CNI) vs. mycophenolate mofetil (MMF) plus standard-dose CNI regimen after kidney transplantation (KT).We searched for RCTs comparing the outcomes of EVR plus low-dose CNI and MMF plus standard-dose CNI regimen after KT and identified eligible RCTs according to strict inclusion and exclusion criteria. Two authors independently assessed the quality of included studies and performed a meta-analysis using RevMan5.3.Eleven RCTs with 850 renal transplant recipients were included. This meta-analysis

2018 Clinical nephrology

4. Effect of conversion from calcineurin inhibitors to everolimus on hepatitis C viremia in adult kidney transplant recipients. Full Text available with Trip Pro

Effect of conversion from calcineurin inhibitors to everolimus on hepatitis C viremia in adult kidney transplant recipients. Currently, there is no specific immunosuppressive protocol for hepatitis C (HCV)-positive renal transplants recipients. Thus, the aim of this study was to evaluate the conversion effect to everolimus (EVR) on HCV in adult kidney recipients.This is an exploratory single-center, prospective, randomized, open label controlled trial with renal allograft recipients with HCV (...) -positive serology. Participants were randomized for conversion to EVR or maintenance of calcineurin inhibitors.Thirty patients were randomized and 28 were followed-up for 12 months (conversion group, Group 1 =15 and control group, Group 2 =13). RT-PCR HCV levels reported in log values were comparable in both groups and among patients in the same group. The statistical analysis showed no interaction effect between time and group (p value G*M= 0.852), overtime intra-groups (p-value M=0.889) and between

2019 Jornal brasileiro de nefrologia : 'orgao oficial de Sociedades Brasileira e Latino-Americana de Nefrologia Controlled trial quality: uncertain

5. Mammalian Target of Rapamycin Inhibitors Combined With Calcineurin Inhibitors as Initial Immunosuppression in Renal Transplantation: A Meta-analysis. (Abstract)

Mammalian Target of Rapamycin Inhibitors Combined With Calcineurin Inhibitors as Initial Immunosuppression in Renal Transplantation: A Meta-analysis. The current standard of care immunosuppressive regimen in kidney transplantation (KT) includes a combination of mycophenolates (MMF/MPA) with a calcineurin inhibitor (CNI).We designed a systematic review including all randomized clinical trials (RCTs) assessing the outcomes in KT recipients receiving mTORi + CNI compared with regimens containing

2019 Transplantation

6. Improved pulse wave velocity and renal function in individualized calcineurin-inhibitor treatment by immunomonitoring: the randomized controlled Calcineurin Inhibitor-Sparing (CIS) Trial. (Abstract)

Improved pulse wave velocity and renal function in individualized calcineurin-inhibitor treatment by immunomonitoring: the randomized controlled Calcineurin Inhibitor-Sparing (CIS) Trial. A new immune monitoring tool which assesses the expression of nuclear factor of activated T cells (NFAT)-regulated genes measures the functional effects of cyclosporine A. This is the first prospective randomized controlled study to compare standard pharmacokinetic monitoring by cyclosporine trough levels

2017 Transplantation Controlled trial quality: uncertain

7. Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation Full Text available with Trip Pro

Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation Background Everolimus permits reduced calcineurin inhibitor (CNI) exposure, but the efficacy and safety outcomes of this treatment after kidney transplant require confirmation.Methods In a multicenter noninferiority trial, we randomized 2037 de novo kidney transplant recipients to receive, in combination with induction therapy and corticosteroids, everolimus with reduced-exposure CNI (everolimus arm) or mycophenolic

2018 EvidenceUpdates

8. Calcineurin inhibitors for renal transplant

Calcineurin inhibitors for renal transplant Calcineurin inhibitors for renal transplant Calcineurin inhibitors for renal transplant Leas BF, Uhl S, Sawinski DL, Trofe-Clark J, Tuteja S, Kaczmarek JL, Umscheid CA Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Leas BF, Uhl S, Sawinski DL, Trofe-Clark J, Tuteja S, Kaczmarek JL, Umscheid CA (...) . Calcineurin inhibitors for renal transplant. Rockville: Agency for Healthcare Research and Quality (AHRQ). Comparative Effectiveness Review No. 166. 2016 Authors' objectives The calcineurin inhibitors (CNIs) tacrolimus and cyclosporine A (CsA) are effective immunosuppressive agents for renal transplantation, but they must be managed carefully to avoid toxicity. Routine therapeutic monitoring guides dosing, but uncertainty surrounds different monitoring methods and timepoints. Additionally

2016 Health Technology Assessment (HTA) Database.

9. Pathology of Calcineurin and Mammalian Target of Rapamycin Inhibitors in Kidney Transplantation Full Text available with Trip Pro

Pathology of Calcineurin and Mammalian Target of Rapamycin Inhibitors in Kidney Transplantation The recent evolution in immunosuppression therapy has led to significant improvement in short-term kidney allograft outcomes; however, this progress did not translate into similar improvement in long-term graft survival. The latter, at least in part, is likely to be attributed to immunosuppressant side effects. In this review, we focus on the histologic manifestations of calcineurin inhibitor (...) and mammalian target of rapamycin inhibitor toxicity. We discuss the pathologic features attributed to such toxicity and allude to the lack of highly specific pathognomonic lesions. Finally, we highlight the importance of clinicopathologic correlation to achieve a meaningful pathologic interpretation.

2017 Kidney international reports

10. Calcineurin-inhibitor minimization in liver transplant patients with calcineurin-inhibitor-related renal dysfunction: a meta-analysis

Calcineurin-inhibitor minimization in liver transplant patients with calcineurin-inhibitor-related renal dysfunction: a meta-analysis Untitled Document The CRD Databases will not be available from 08:00 BST on Friday 4th October until 08:00 BST on Monday 7th October for essential maintenance. We apologise for any inconvenience.

2011 DARE.

11. Outcomes of Conversion from Calcineurin Inhibitor to Belatacept-Based Immunosuppression in HLA Sensitized Kidney Transplant Recipients. (Abstract)

Outcomes of Conversion from Calcineurin Inhibitor to Belatacept-Based Immunosuppression in HLA Sensitized Kidney Transplant Recipients. The efficacy and safety of belatacept when converted from calcineurin inhibitors (CNI) in HLA-sensitized kidney transplant recipients has not been established.The study included 108 kidney transplant recipients converted from CNI to belatacept between 7/1/12 to 9/30/17. Rejection-free, patient, and graft survival over 5 years follow-up were compared between HLA

2019 Transplantation

12. Randomized Sirolimus-based early calcineurin inhibitor reduction in liver transplantation: impact on renal function. (Abstract)

Randomized Sirolimus-based early calcineurin inhibitor reduction in liver transplantation: impact on renal function. The long-term use of calcineurin inhibitors (CNI) after liver transplantation (LT) is associated with nephrotoxicity.5-year follow-up data was retrieved from the randomized controlled multicenter SiLVER trial. Standard CNI-based mTOR-free immunosuppression (group A, n=264) was compared to a 50 % reduction of CNI and introduction of the mTOR inhibitor Sirolimus within 4 to 6 weeks

2019 Transplantation

13. Belatacept-based immunosuppression: A calcineurin inhibitor-sparing regimen in heart transplant recipients. (Abstract)

Belatacept-based immunosuppression: A calcineurin inhibitor-sparing regimen in heart transplant recipients. Belatacept (BTC) is indicated for prophylaxis of graft rejection in adults receiving a renal transplant (Tx). This retrospective observational study (three centers) included all heart transplant recipients receiving BTC between January 2014 and October 2018. Forty EBV+ patients mean GFR 35 ± 20 mL/min/m2 were identified, among whom belatacept was initiated during the first 3 months after

2019 American Journal of Transplantation

14. Comparison of the immunogenicity of Dukoral® oral cholera vaccine between renal transplant recipients on either a calcineurin inhibitor or mycophenolate - A controlled trial. (Abstract)

Comparison of the immunogenicity of Dukoral® oral cholera vaccine between renal transplant recipients on either a calcineurin inhibitor or mycophenolate - A controlled trial. The evidence for recommendations regarding vaccination in solid organ transplant recipients is sparse. There is little data comparing vaccine responses between groups on different immunosuppressive drugs. This study was conducted to evaluate the antibody response to Dukoral® oral cholera vaccine in renal transplant (...) recipients (RTR).In a single-center non-randomized controlled clinical trial, healthy volunteers (n = 21) and renal transplant recipients (n = 30) were vaccinated with the oral whole cell/recombinant B subunit cholera vaccine Dukoral® (Valneva Inc., Vienna, Austria). The RTR were stratified according to their maintenance immunosuppressive therapy: either prednisone and a calcineurin inhibitor (cyclosporine A or tacrolimus; P/CNI group; n = 15) or prednisone and mycophenolate (P/MMF group; n = 15). All

2019 Vaccine Controlled trial quality: predicted high

15. Correlation between gene polymorphism and blood concentration of calcineurin inhibitors in renal transplant recipients: An overview of systematic reviews. Full Text available with Trip Pro

Correlation between gene polymorphism and blood concentration of calcineurin inhibitors in renal transplant recipients: An overview of systematic reviews. To provide an overview of systematic reviews and meta-analyses (SRs/MAs) of the correlation between genetic polymorphisms and blood concentrations of calcineurin inhibitors (CNIs) in recipients of renal transplant.Databases including Medline, EMBase, The Cochrane Library (Issue 7, 2016), the Chinese Biomedical Literature Database, the China

2019 Medicine

16. S1Everolimus Initiation With Early Calcineurin Inhibitor Withdrawal in De Novo Heart Transplant Recipients: Long-term Follow-up From the Randomized SCHEDULE Study. (Abstract)

S1Everolimus Initiation With Early Calcineurin Inhibitor Withdrawal in De Novo Heart Transplant Recipients: Long-term Follow-up From the Randomized SCHEDULE Study. A calcineurin inhibitor free immunosuppressive regimen has been demonstrated to improve renal function early after heart transplantation, but long-term outcome of such a strategy has not been well described.In the randomized SCHEDULE trial, de novo heart transplant recipients received (1) everolimus with reduced-exposure calcineurin (...) inhibitor (CNI, cyclosporine) followed by CNI withdrawal at weeks 7-11 post-transplant or (2) standard-exposure cyclosporine, both with mycophenolate mofetil and corticosteroids; 95/115 randomized patients were followed up at 5-7 years post-transplant.Mean measured GFR was 74.7mL/min and 62.4mL/min with everolimus and CNI, respectively. The mean difference was in favor of everolimus by 11.8 mL/min in the intent-to-treat population (P = 0.004) and 17.2 mL/min in the per protocol population (n = 75; P

2019 Transplantation Controlled trial quality: uncertain

17. Comparing everolimus-based immunosuppression with reduction or withdrawal of calcineurin inhibitor reduction from six months after heart transplantation: the randomized MANDELA study. (Abstract)

Comparing everolimus-based immunosuppression with reduction or withdrawal of calcineurin inhibitor reduction from six months after heart transplantation: the randomized MANDELA study. In the 12-month, open-label MANDELA study, patients were randomized at month 6 after heart transplantation to (i) convert to calcineurin inhibitor (CNI)-free immunosuppression with everolimus (EVR), mycophenolic acid and steroids (CNI-free, n=71), or to (ii) continue reduced-exposure CNI, with EVR and steroids

2019 American Journal of Transplantation Controlled trial quality: uncertain

18. Topical calcineurin inhibitors in the treatment of oral lichen planus: a systematic review and meta-analysis. (Abstract)

Topical calcineurin inhibitors in the treatment of oral lichen planus: a systematic review and meta-analysis. TCS (topical corticosteroids) is the first-line drug in the treatment of oral lichen planus (OLP). However, the value of topical calcineurin inhibitors (TCI) including tacrolimus, pimecrolimus and cyclosporine for OLP is still controversial.The article was carried out to compare the efficacy and safety of TCI with TCS for OLP.We searched PubMed/EMBASE/the Cochrane Central Register

2019 British Journal of Dermatology

19. Safety of Everolimus With Reduced Calcineurin Inhibitor Exposure in De Novo Kidney Transplants: An Analysis From the Randomized TRANSFORM Study. (Abstract)

Safety of Everolimus With Reduced Calcineurin Inhibitor Exposure in De Novo Kidney Transplants: An Analysis From the Randomized TRANSFORM Study. The safety profiles of standard therapy versus everolimus with reduced-exposure calcineurin inhibitor (CNI) therapy using contemporary protocols in de novo kidney transplant recipients have not been compared in detail.TRANSFORM was a randomized, international trial in which de novo kidney transplant patients were randomized to everolimus with reduced

2019 Transplantation Controlled trial quality: uncertain

20. Donor age predicts calcineurin inhibitor induced neurotoxicity after liver transplantation. (Abstract)

Donor age predicts calcineurin inhibitor induced neurotoxicity after liver transplantation. Calcineurin inhibitor-induced neurotoxicity (CIIN) is a common and debilitating side effect after liver transplantation (LT). Risk factors and impact on patient outcomes are not well defined. Our aim was to assess the incidence, risk factors and clinical outcomes of CIIN.We retrospectively analysed 175 LT performed at our centre between January 2010 and September 2016. Donor and recipient demographics

2019 Transplantation

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