Evidence map›Paper›PMID 32756556›Full record

Observational studyPloS one2020

Early conversion to a CNI-free immunosuppression with SRL after renal transplantation-Long-term follow-up of a multicenter trial.

Joachim Andrassy, Markus Guba, Antje Habicht, Michael Fischereder, Johann Pratschke, Andreas Pascher, Katharina M Heller, Bernhard Banas, Oliver Hakenberg, Thomas Vogel and 5 more

Abstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in PloS one, 2020. 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. Article
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

15 authors.

Joachim AndrassyDepartment of General, Visceral, and Transplant Surgery, Ludwig-Maximilian's University, Campus Grosshadern, Munich, Germany.ORCID 0000-0001-8303-3913
Markus GubaDepartment of General, Visceral, and Transplant Surgery, Ludwig-Maximilian's University, Campus Grosshadern, Munich, Germany.
Antje HabichtTransplant Department, Ludwig-Maximilian's University, Campus Grosshadern, Munich, Germany.
Michael FischerederDepartment of Medicine, MED IV, Nephrology, Ludwig-Maximilian's University, Campus Grosshadern, Munich, Germany.
Johann PratschkeDepartment of General, Visceral, and Transplant Surgery, Charité, Campus Virchow-Clinic, Berlin, Germany.
Andreas PascherDepartment of General, Visceral, and Transplant Surgery, Charité, Campus Virchow-Clinic, Berlin, Germany.
Katharina M HellerDepartment of Medicine, Division of Nephrology, University of Erlangen, Germany.
Bernhard BanasDepartment of Internal Medicine II, Nephrology and Transplantation, University Medical Center, Regensburg, Germany.
Oliver HakenbergDepartment of Urology, University of Rostock, Germany.
Thomas VogelDepartment of General, Visceral, and Transplant Surgery, University of Münster, Münster, Germany.ORCID 0000-0002-3275-7329
Bruno MeiserTransplant Department, Ludwig-Maximilian's University, Campus Grosshadern, Munich, Germany.
Andrea DickLaboratory for Immunogenetics, Division of Transfusion Medicine, Cell Therapeutics and Hemostaseology, Ludwig-Maximilian's University, Munich, Germany.
Jens WernerDepartment of General, Visceral, and Transplant Surgery, Ludwig-Maximilian's University, Campus Grosshadern, Munich, Germany.
Teresa KaukeDepartment of General, Visceral, and Transplant Surgery, Ludwig-Maximilian's University, Campus Grosshadern, Munich, Germany.
SMART-Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEarly conversion to a CNI-free immunosuppression with SRL was associated with an improved 1- and 3- yr renal function as compared with a CsA-based regimen in the SMART-Trial. Mixed results were reported on the occurrence of donor specific antibodies under mTOR-Is. Here, we present long-term results of the SMART-Trial. METHODS AND MATERIALS: N = 71 from 6 centers (n = 38 SRL and n = 33 CsA) of the original SMART-Trial (ITT n = 140) were enrolled in this observational, non-interventional extension study to collect retrospectively and prospectively follow-up data for the interval since baseline. Primary objective was the development of dnDSA. Blood samples were collected on average 8.7 years after transplantation.

resultsDevelopment of dnDSA was not different (SRL 5/38, 13.2% vs. CsA 9/33, 27.3%; P = 0.097). GFR remained improved under SRL with 64.37 ml/min/1.73m2 vs. 53.19 ml/min/1.73m2 (p = 0.044). Patient survival did not differ between groups at 10 years. There was a trend towards a reduced graft failure rate (11.6% SRL vs. 23.9% CsA, p = 0.064) and less tumors under SRL (2.6% SRL vs. 15.2% CsA, p = 0.09).

conclusionsAn early conversion to SRL did not result in an increased incidence of dnDSA nor increased long-term risk for the recipient. Transplant function remains improved with benefits for the graft survival.

Indexed as

Calcineurin InhibitorsImmunosuppression TherapyImmunosuppressive AgentsKidney TransplantationSirolimusAdultAntibody SpecificityDrug Administration ScheduleFemaleFollow-Up StudiesGlomerular Filtration RateGraft RejectionGraft SurvivalHumansKaplan-Meier EstimateMaleCalcineurin InhibitorsImmunosuppressive AgentsMTOR protein, humanSirolimusTOR Serine-Threonine Kinases

Identifiers

PMID32756556
PMCPMC7406080

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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 OpenQuestion graph.