Clinical impact using low dose mycophenolate mofetil with tacrolimus on acute rejection, infectious diseases and non-infectious complications in renal transplant: A Single Hospital Experience in Mexico.

Abstract

Background The evidence supporting a starting dose of 2 g/day of mycophenolate mofetil (MMF) in combination with tacrolimus (TAC) in renal transplant (RT) is still limited but maintaining the dose of less than 2g could result in worse clinical outcomes in terms of acute rejection (AR).

Research Question This study’s aim was to determine the association between AR, infectious and non-infectious complications after RT with the dose of 1.5g vs. 2g of MMF.

Design A prospective cohort was performed with a 12-month follow-up in recipients of RT from living donors with low doses of MMF (1.5 g/day) or use of standard dosage (2 g/day). The association between adverse effects and complications and doses of MMF were examined in Cox proportional hazard models and survival free of AR, infectious diseases, and non-infectious complications was evaluated by the Kaplan-Meier test.

Results At the end of the follow-up, the incidence of infectious diseases was 52% vs. 50% (p=0.71) and AR was 5% vs. 5% (p=0.86), respectively. Survival free of GI complications requiring medical attention was higher in the low dose group compared to the standard dose (88% vs. 45%, respectively; p<0.001).

Discussion The use of 1.5 g/day of MMF is safe in Mexican population with RT from living donors without increasing the risk of AR, and it confers a reduction of adverse events.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

The study did not receive any private or governmental funding.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was approved by the Ethics and Research Committee of the Specialties Hospital, National Western Medical Centre, Mexican Institute of Social Security (IMMS) in Mexico with registration number: R-2017-1301-108.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

Data availability Most clinical data are restricted to protect information against misuse. The data may be shared by the Mexican Social Security Institute (IMSS) after approval from the Ethics Committee of the institution. The data that support the findings of this study are available from the corresponding author upon reasonable request.

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