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Effect of FTY720 (fingolimod) on graft survival in renal transplant recipients: a systematic review protocol
Reza Gholamnezhadjafari1, Reza Falak2, Nader Tajik2
1Department of Immunology, Isfahan University of Medical Sciences, Isfahan, Iran.
Introduction:
Studies have shown that FTY720 has inconsistent effects in kidney transplant recipients. Several review articles on FTY720 have been published, but most have focused on the mechanism of action of FTY720. Therefore, this review aims to evaluate and determine the beneficial and harmful effects of FTY720 therapy in kidney transplant recipients.
Methods And Analysis:
We electronically searched the following databases: PubMed, Scopus, the Web of Sciences, EMBASE, Cochrane databases and the Cochrane Central Registry of Controlled Trials. Any clinical, randomised controlled trials relating to FTY720 for treating kidney transplant recipients were included without publication status or language restriction. Study selection, data extraction and assessment of study quality were performed independently by two researchers. Data were synthesised by either the fixed effects or the random effects model according to a heterogeneity test. If the extracted data were suitable for meta-analysis, STATA software was used to combine the relative risks for dichotomous outcomes, and the mean differences for continuous outcomes with 95% CIs were measured. Death, loss of function and incidence of acute kidney rejection were assessed as the primary outcomes. Renal graft function, malignancy, delayed graft function and infection were evaluated as secondary outcomes.
Ethics/Dissemination:
This review does not require formal ethics approval because the data are not individualised. The resulting review article will be submitted for publication in a peer-reviewed journal.
Trial Registration Number:
CRD42015024648.
Insights
This review evaluates FTY720 therapy in kidney transplant recipients to determine its benefits and harms. The analysis synthesizes data from randomized controlled trials to assess FTY720
Area of Science:
- Nephrology
- Immunology
- Pharmacology
Background:
- FTY720 (fingolimod) exhibits variable efficacy in kidney transplant recipients.
- Existing reviews primarily focus on FTY720's mechanism of action, not clinical outcomes.
- A comprehensive evaluation of FTY720's therapeutic impact in this population is warranted.
Purpose of the Study:
- To systematically review and synthesize evidence on the beneficial and harmful effects of FTY720 therapy in kidney transplant recipients.
- To assess FTY720's impact on primary outcomes including death, graft loss, and acute rejection.
- To evaluate secondary outcomes such as renal graft function, malignancy, delayed graft function, and infection.
Main Methods:
- A comprehensive electronic search of multiple databases (PubMed, Scopus, Web of Science, EMBASE, Cochrane) was conducted.
- Inclusion criteria encompassed randomized controlled trials of FTY720 in kidney transplant recipients, irrespective of language or publication status.
- Data synthesis involved fixed or random effects models, with meta-analysis performed using STATA for relative risks and mean differences.
Main Results:
- Data synthesis is ongoing, with primary outcomes including mortality, graft loss, and acute kidney rejection.
- Secondary outcomes under evaluation comprise renal graft function, malignancy incidence, delayed graft function, and infection rates.
- The review aims to provide a quantitative assessment of FTY720's efficacy and safety profile.
Conclusions:
- This systematic review will provide critical insights into the net clinical benefit of FTY720 in kidney transplantation.
- Findings will inform clinical decision-making regarding the use of FTY720 in this patient cohort.
- The study contributes to optimizing immunosuppressive strategies post-kidney transplantation.
