Evidence map›Paper›PMID 14577021›Full record

Trial reportPediatric nephrology (Berlin, Germany)2003

Cyclosporine absorption profiles in pediatric kidney and liver transplant patients.

J M Kovarik, Peter F Hoyer, Robert Ettenger, Jeffrey Punch, Marianne Soergel

Open access · greenAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Pediatric nephrology (Berlin, Germany), 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.4field-weighted citation impact, top 21% 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.

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

2 citing papers in PubMed, 21 citations in OpenAlex.

  1. Trial
  2. 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

5 authors at 4 institutions in 3 countries.

J M KovarikNovartis Pharma AG, Building WSJ 27.4093, 4002 Basel, Switzerland. john.kovarik@pharma.novartis.com
Peter F Hoyer
Robert Ettenger
Jeffrey Punch
Marianne Soergel
Novartis (Switzerland) · CHEssen University Hospital · DEMattel Children's Hospital · USUniversity of Michigan–Ann Arbor · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cyclosporine absorption profiling uses either the area under the concentration curve in the first 4 h post dose, AUC(0-4), or the concentration 2 h post dose (C2) to optimize immunosuppression in adult kidney and liver transplantation. We characterized C2 versus AUC(0-4) relationships over time after transplant and across transplant indications in 56 pediatric transplant patients. There were 36 kidney transplant patients aged 9.7+/-3.9 years. Nineteen of these patients were studied in the de novo period on day 7 post transplant and 17 in the maintenance phase more than 1 year post transplant. In addition, 20 liver transplant patients aged 8.9+/-4.2 years were studied in the maintenance phase. All patients had five blood samples collected over the 12-h dose interval that were analyzed by validated assay methods at a central laboratory. Pediatric C2 values were 1,463+/-658 ng/ml for de novo kidney, 954+/-322 ng/ml for maintenance kidney, and 619+/-339 ng/ml for maintenance liver transplant patients. C2 was a strong predictor of AUC(0-4) in all three pediatric groups, with coefficients of determination ( r(2)) ranging from 0.861 to 0.936. Although data were limited from the de novo period, the C2 versus AUC(0-4) regression was consistent over time after transplant and between transplant indications, with a regression slope of 2.50 in de novo kidney, 2.54 in maintenance kidney, and 2.76 in maintenance liver transplant recipients. These slopes were also comparable to that in adult maintenance kidney transplant patients (2.60). In conclusion, C2 versus AUC(0-4) relationships demonstrated consistency over time (de novo vs. maintenance phase), between transplant indications (kidney vs. liver), and across age groups (pediatric vs. adult patients). Average C2 values achieved with current pediatric cyclosporine dosing practices cluster around the target C2 ranges recommended for adults.

Indexed as

AdolescentArea Under CurveChildChild, PreschoolCyclosporineDose-Response Relationship, DrugFemaleHumansImmunosuppressive AgentsIntestinal AbsorptionKidney TransplantationLiver TransplantationMaleCyclosporineImmunosuppressive Agents

Identifiers

PMID14577021
OpenAlexW2024438194

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

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.