Evidence map›Paper›PMID 27286686›Full record

ArticlePediatric nephrology (Berlin, Germany)2016

Sirolimus and tacrolimus coefficient of variation is associated with rejection, donor-specific antibodies, and nonadherence.

Helen P Pizzo, Robert B Ettenger, David W Gjertson, Elaine F Reed, Jennifer Zhang, H Albin Gritsch, Eileen W Tsai

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Pediatric nephrology (Berlin, Germany), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05335538 (The Role of TruGraf® to Optimize Outcomes in Pediatric Renal Transplantation), which is not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
6.1field-weighted citation impact, top 3% of its field
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.

NCT05335538 unknown statusnot on this mapstarted 2021, after this paper: background citation

The Role of TruGraf® to Optimize Outcomes in Pediatric Renal Transplantation

TypeobservationalSponsorTransplant Genomics, Inc.Ran2021 to 2023Enrolled75ConditionsKidney Transplant RejectionArmsPatients monitored with TruGraf and TRAC testing
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 71 citations in OpenAlex.

  1. Pooled it
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  13. Patient Engagement and Medication Consistency with Adolescent Heart Transplant Recipients.Proceedings. IEEE International Conference on Healthcare Informatics · 2024
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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 at 3 institutions in 1 country.

Helen P PizzoDivision of Pediatric Nephrology, Cedars-Sinai Medical Center, Los Angeles, CA, USA. helen.pizzo@cshs.org.
Robert B EttengerDivision of Pediatric Nephrology, Mattel Children's Hospital UCLA, Los Angeles, CA, USA.
David W GjertsonUCLA Department of Pathology and Laboratory Medicine, Los Angeles, CA, USA.
Elaine F ReedUCLA Department of Pathology and Laboratory Medicine, Los Angeles, CA, USA.
Jennifer ZhangUCLA Department of Pathology and Laboratory Medicine, Los Angeles, CA, USA.
H Albin GritschUCLA Department of Urology, Los Angeles, CA, USA.
Eileen W TsaiDivision of Pediatric Nephrology, Mattel Children's Hospital UCLA, Los Angeles, CA, USA.
University of California, Los Angeles · USMattel Children's Hospital · USCedars-Sinai Medical Center · US

Funding

Anti-MHC Effects on EndotheliumR01AI042819 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI REED, ELAINE F · 1999 to 2014
$4.0M
NIAID NIH HHS R01 AI042819
6 · The paper itself

Abstract

backgroundImmunosuppression medication nonadherence has been associated with donor-specific antibodies and treatment-refractory rejection. Drug-level monitoring is a practical direct marker for nonadherence, as variations indicate erratic ingestion of medication. We previously reported that high variability in tacrolimus trough levels determined by the percent coefficient of variation (CV %) and standard deviation (SD) were associated with biopsy-proven rejection. We hypothesized that the CV % and SD in patients on a sirolimus/low-dose tacrolimus regimen may associate with self-reported medication nonadherence, rejection and donor-specific antibodies.

methodsIn this pilot feasibility study, we studied 37 biopsies in 23 pediatric renal transplant patients on both sirolimus and tacrolimus immunosuppression; CV %, SD, de novo donor-specific antibodies, rejection, and self-reported adherence were examined.

resultsA cut-off sirolimus CV % of 25 maximized the percentage of biopsies correctly classified as rejection (32 of 37, or 86 %, p = 0.001). A cut-off tacrolimus CV % of 31 maximized the percentage of correctly classified biopsies (25 of 37, or 68 %, p = 0.09). Among patients with both high sirolimus and tacrolimus CV %, 67 % developed de novo donor-specific antibodies (p = 0.002) with a DQ predominance and 71 % reported nonadherence (p = 0.05).

conclusionsIn pediatric renal transplantation, sirolimus and tacrolimus CV % is a potential tool for monitoring patients at risk for allograft rejection and donor-specific antibodies secondary to medication nonadherence.

Indexed as

Medication AdherenceTissue DonorsAntibodiesChildChild, PreschoolFeasibility StudiesFemaleGraft RejectionGraft SurvivalHumansImmunosuppressive AgentsInfantKidneyKidney TransplantationMalePilot ProjectsAntibodiesImmunosuppressive AgentsSirolimusTacrolimusCalcineurin inhibitorComplianceDrug levelsImmunosuppressionMammalian target of rapamycin inhibitor

Identifiers

PMID27286686
OpenAlexW2419008429

What OpenQuestion holds

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Registered trials

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.