Evidence map›Paper›PMID 18688657›Full record

Trial reportPediatric nephrology (Berlin, Germany)2009

Multicentre prospective randomised trial of tacrolimus, azathioprine and prednisolone with or without basiliximab: two-year follow-up data.

Nicholas J A Webb, Sylwester Prokurat, Karel Vondrak, Alan R Watson, David A Hughes, Stephen D Marks, Nadeem E Moghal, Maggie M Fitzpatrick, David V Milford, Moin A Saleem and 6 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Pediatric nephrology (Berlin, Germany), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Interleukin 2 receptor antagonists for kidney transplant recipients.The Cochrane database of systematic reviews · 2010
    Pooled it
  2. Article
  3. 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

16 authors.

Nicholas J A WebbDepartment of Paediatric Nephrology, Royal Manchester Children's Hospital, Manchester, M27 4HA, UK. nicholas.webb@cmmc.nhs.uk
Sylwester Prokurat
Karel Vondrak
Alan R Watson
David A Hughes
Stephen D Marks
Nadeem E Moghal
Maggie M Fitzpatrick
David V Milford
Moin A Saleem
Caroline A Jones
Styrbjorn Friman
Rita Van Damme-Lombaerts
Francoise Janssen
Clare Hamer
Sarah Rhodes

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A total of 192 children and adolescents undergoing renal transplantation were randomly chosen to receive tacrolimus, azathioprine and corticosteroids (TAS, n = 93) or tacrolimus, azathioprine, corticosteroids and two doses of basiliximab (TAS + B, n = 99). Six-month outcome data have previously been reported; this manuscript reports the 2-year data. Complete 2-year data were available on 164 (85.4%) of the original 192 patients. There was a single death in the TAS arm. Kaplan-Meier estimates of survival free of graft loss at 2 years were 94.9% in the TAS + B arm and 89.6% in the TAS arm [hazard ratio (HR) 0.52; 95% confidence interval (CI) 0.17 to 1.54, P = 0.23]. Estimates of survival free from rejection at 2 years were 75.2% in the TAS + B arm and 68.7% in the TAS arm (HR 0.81; 95% CI 0.46 to 1.40, P = 0.44). The mean estimated glomerular filtration rate (GFR) at 2 years, was 65.8 ml/min per 1.73 m(2) body surface area in the TAS arm and 66.7 ml/min per 1.73 m(2) in the TAS + B arm (P = 0.78). Blood pressure and cholesterol levels were similar in the two arms, and there was no evidence of a difference in the incidence of infection or malignancy. These data provide further evidence of a lack of benefit associated with the addition of basiliximab to a TAS regimen for European paediatric renal transplant recipients at low immunological risk.

Indexed as

AdolescentAntibodies, MonoclonalAzathioprineBasiliximabChildDrug Therapy, CombinationFemaleGlomerular Filtration RateGraft RejectionHumansImmunosuppression TherapyImmunosuppressive AgentsKidney TransplantationMalePrednisoloneProspective StudiesAntibodies, MonoclonalAzathioprineBasiliximabImmunosuppressive AgentsPrednisoloneRecombinant Fusion ProteinsTacrolimus

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.