Evidence map›Paper›PMID 16550361›Full record

ArticlePediatric nephrology (Berlin, Germany)2006

The pharmacokinetics and immunosuppressive response of tacrolimus in paediatric renal transplant recipients.

Giovanni Montini, Francesca Ujka, Cristina Varagnolo, Luciana Ghio, Fabrizio Ginevri, Luisa Murer, Basile S Thafam, Carla Carasi, Graziella Zacchello, Mario Plebani

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Pediatric nephrology (Berlin, Germany), 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01767350 (Study Aimed at Determining the Relation Between the Administered Dose and Exposure to Immunosuppressive Medication in Children After Solid Organ Transplantation), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing 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.

NCT01767350 completednot on this mapstarted 2013, after this paper: background citation

Study Aimed at Determining the Relation Between the Administered Dose and Exposure to Immunosuppressive Medication in Children After Solid Organ Transplantation

TypeobservationalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2013 to 2015Enrolled60ConditionsTransplantation InfectionArmsBlood withdrawal for DNA
3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

  1. Observational
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Therapeutic drug monitoring in pediatric renal transplantation.Pediatric nephrology (Berlin, Germany) · 2015
    Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
  16. Review
  17. Review
  18. 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

10 authors.

Giovanni MontiniNephrology, Dialysis and Transplant Unit, Pediatric Department, University Hospital, Via Giustiniani 3, 35128, Padua, Italy. montini@pediatria.unipd.it
Francesca Ujka
Cristina Varagnolo
Luciana Ghio
Fabrizio Ginevri
Luisa Murer
Basile S Thafam
Carla Carasi
Graziella Zacchello
Mario Plebani

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aims of our trial were to study the pharmacokinetics of tacrolimus in paediatric kidney transplant recipients. The study comprised 25 patients (median age 13 years, range 2-20 years) followed for 12 months; five pharmacokinetics profiles (within the first and second week and after 1 month, 6 months and 12 months) were obtained. Patients were divided into two groups: six children<6 years old and 19 older children. Tacrolimus was given at an initial dose of 0.15 mg/kg twice a day. Blood samples were drawn before and 1 h, 2 h, 3 h, 4 h, 6 h, 9 h and 12 h after drug administration. Patient and kidney survival rates were 100% at 1 year. At 6 months and 12 months creatinine clearance was 68.5+/-16.3 ml/min per 1.73 m2 and 64.0+/-15.2 ml/min per 1.73 m2 body surface area, respectively. Tacrolimus trough levels were 7.8+/-1.9 ng/ml and 7.3+/-2.5 ng/ml. The area under the concentration-time curve for 0 h to 12 h (AUC0-12) normalised to a dose of 0.15 mg/kg, increased with time from the kidney transplantation and stabilised after the 6th month post-transplantation. During the first month after transplantation the normalised tacrolimus concentration-time profiles were significantly greater in the older children (P<0.05); the actual doses were significantly greater in the younger children (P<0.05). In conclusion, initial doses of 0.15 mg/kg twice a day orally are safe and guarantee a satisfactory degree of immunosuppression, with our therapeutic regimen. Children<6 years old need to start with a 50% higher tacrolimus dose to achieve the same pharmacokinetic and immunosuppressive results.

Indexed as

Kidney TransplantationAdolescentAdultAge FactorsArea Under CurveChildChild, PreschoolDrug MonitoringFemaleFollow-Up StudiesGraft SurvivalHumansImmunosuppressive AgentsKidney Failure, ChronicMaleProspective StudiesImmunosuppressive AgentsTacrolimus

Identifiers

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.