Evidence map›Paper›PMID 29637588›Full record

Trial reportBritish journal of clinical pharmacology2018

Population pharmacokinetics of tacrolimus in children with nephrotic syndrome.

Guo-Xiang Hao, Xin Huang, Dong-Feng Zhang, Yi Zheng, Hai-Yan Shi, Yan Li, Evelyne Jacqz-Aigrain, Wei Zhao

Registry-linked trialOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04045171 (Population Pharmacokinetics of Tacrolimus for Optimal Dose in Patients With Nephrotic Syndrome), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 10% 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.

NCT04045171 unknown statusnot on this mapstarted 2019, after this paper: background citation

Population Pharmacokinetics of Tacrolimus for Optimal Dose in Patients With Nephrotic Syndrome

TypeobservationalSponsorThe Third Xiangya Hospital of Central South UniversityRan2019 to 2020Enrolled200ConditionsNephrotic Syndrome, Tacrolimus, PharmacokineticsArmsTacrolimus
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

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  17. Paediatric drugs trials in China.BMJ paediatrics open · 2020
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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

8 authors at 2 institutions in 2 countries.

Guo-Xiang HaoDepartment of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China.
Xin HuangDepartment of Pharmacy, Shandong Provincial Qianfoshan Hospital, Shandong University, Jinan, China.
Dong-Feng ZhangDepartment of Pediatric Nephrology, Children's Hospital of Hebei Province, Shijiazhuang, China.
Yi ZhengDepartment of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China.
Hai-Yan ShiDepartment of Pharmacy, Shandong Provincial Qianfoshan Hospital, Shandong University, Jinan, China.
Yan LiDepartment of Pharmacy, Shandong Provincial Qianfoshan Hospital, Shandong University, Jinan, China.
Evelyne Jacqz-AigrainDepartment of Pediatric Nephrology, Children's Hospital of Hebei Province, Shijiazhuang, China.ORCID 0000-0002-4285-7067
Wei ZhaoDepartment of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China.ORCID 0000-0002-1830-338X
Shandong University · CNHospital of Hebei Province · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsNephrotic syndrome (NS) is the most common clinical manifestation of glomerular disease in children. Currently, tacrolimus (TAC) is widely used in children with NS. However, pharmacokinetic data in children with nephrotic syndrome is limited. This study was intended to evaluate the population pharmacokinetics (PPK) of TAC in paediatric NS and to optimize dosing regimen.

methodsBlood samples from NS children treated with TAC were collected and the blood concentrations of TAC were detected using HPLC-MS/MS. A PPK model was developed using NONMEM software. Pharmacogenetic analysis was carried out in the CYP3A5 gene.

resultsThe data from 28 children were used for PPK analysis. A one-compartment model and first-order elimination were accorded with the TAC data in paediatric NS. A covariate analysis showed that body weight and CYP3A5 genotype significantly affected TAC pharmacokinetics. Monte Carlo simulation indicated that NS children with CYP3A5*3/*3 receiving 0.10 mg kg

conclusionThe PPK of TAC was estimated in children with NS and a CYP3A5 genotype-based dosing regimen was set up based on simulations.

Indexed as

AdolescentCalcineurin InhibitorsChildChild, PreschoolCytochrome P-450 CYP3ADose-Response Relationship, DrugDrug Administration ScheduleFemaleGlomerulosclerosis, Focal SegmentalHumansImmunosuppressive AgentsMaleModels, BiologicalNephrotic SyndromeProspective StudiesTacrolimusCalcineurin InhibitorsCYP3A5 protein, humanCytochrome P-450 CYP3AImmunosuppressive AgentsTacrolimuschildrennephrotic syndromepharmacokineticstacrolimus

Identifiers

PMID29637588
PMCPMC6046506
OpenAlexW2796842808

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.