Evidence map›Paper›PMID 33681893›Full record

Trial reportBrazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica2021

An open-label randomized clinical trial to evaluate the efficacy of everolimus versus tacrolimus in triple maintenance immunosuppressive therapy for kidney transplant patients.

B P S Assis, M F Lasmar, R A Fabreti-Oliveira, S A Araujo, J Oliveira, D C Wanderley, E Nascimento

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

B P S AssisHospital Universitário da Faculdade de Ciências Médicas, Belo Horizonte, MG, Brasil.ORCID http://orcid.org/0000-0002-2215-1366
M F LasmarHospital Universitário da Faculdade de Ciências Médicas, Belo Horizonte, MG, Brasil.ORCID http://orcid.org/0000-0001-7912-5268
R A Fabreti-OliveiraFaculdade de Ciências Médicas, Belo Horizonte, MG, Brasil.ORCID http://orcid.org/0000-0001-9128-0666
S A AraujoInstituto de Nefropatologia, Belo Horizonte, MG, Brasil.ORCID http://orcid.org/0000-0001-9996-4405
J OliveiraFaculdade de Ciências Médicas, Belo Horizonte, MG, Brasil.ORCID http://orcid.org/0000-0003-3538-8191
D C WanderleyInstituto de Nefropatologia, Belo Horizonte, MG, Brasil.ORCID http://orcid.org/0000-0003-1201-9449
E NascimentoFaculdade de Ciências Médicas, Belo Horizonte, MG, Brasil.ORCID http://orcid.org/0000-0002-7008-4022

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tacrolimus (TAC), a calcineurin inhibitor, and everolimus (EVL), an mTOR inhibitor, have been used as immunosuppressive (ISS) drugs in post-kidney transplantation therapy. The objective of this study was to compare the efficacy of EVL vs TAC in the ISS maintenance triple therapy. Ninety-seven kidney transplant patients, who received triple maintenance therapy with TAC, mycophenolate mofetil (MMF), and methyl prednisone (PRED), were evaluated. After four months of post-kidney transplant therapy, 30 patients enrolled in a randomized controlled clinical trial, in which 16 patients received TAC+MMF+PRED (cohort 1), and 14 patients switched to EVL+MMF+PRED (cohort 2). The patients were followed-up for 36 months. Two patients from cohort 1 lost their grafts after one year due to non-adherence. Two patients from cohort 2 had intolerance to mTOR inhibitors and were switched back to TAC from EVL. One case (6.25%) in cohort 1 and three cases (21.43%) in cohort 2 of acute T-cell-mediated rejection was observed. Antibody-mediated acute rejection (ABMAR) was observed in four patients (25.0%) in cohort 1, and antibody-mediated chronic rejection (ABMCR) was observed in two patients (12.50%). One patient from cohort 2 lost the graft after 15 months due to polyomavirus infection. The graft survival rate was 87.50% in cohort 1 and 92.86% in cohort 2. This clinical trial showed that the EVL+MMF+PRED triple maintenance therapy was efficacious compared with TAC during 32 months of follow-up. However, further studies are needed to confirm the efficacy of this regimen for long-term graft survival.

Indexed as

Kidney TransplantationTacrolimusDrug Therapy, CombinationEverolimusGraft RejectionGraft SurvivalHumansImmunosuppressive AgentsEverolimusImmunosuppressive AgentsTacrolimus

Identifiers

PMID33681893
PMCPMC7931813

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.