Evidence map›Paper›PMID 22694755›Full record

Trial reportAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2012

Complete steroid avoidance is effective and safe in children with renal transplants: a multicenter randomized trial with three-year follow-up.

M M Sarwal, R B Ettenger, V Dharnidharka, M Benfield, R Mathias, A Portale, R McDonald, W Harmon, D Kershaw, V M Vehaskari and 10 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00141037 (Randomized, Multi-Center Comparative Trial of Tacrolimus w/Steroids and Standard Daclizumab Induction vs a Novel Steroid-Free Tacrolimus Based Immunosuppression Protocol w/ Extended Daclizumab Induction in Pediatric Renal Transplantation), which is not on this map. Cited by 45 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 3 pooled it
11.2field-weighted citation impact, top 1% 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.

NCT00141037 phase1 / phase2completednot on this map

Randomized, Multi-Center Comparative Trial of Tacrolimus w/Steroids and Standard Daclizumab Induction vs a Novel Steroid-Free Tacrolimus Based Immunosuppression Protocol w/ Extended Daclizumab Induction in Pediatric Renal Transplantation

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2004 to 2010Enrolled130ConditionsKidney Diseases, Kidney Transplantation, Kidney Transplant, Renal TransplantationArmsDaclizumab, Mycophenolate mofetil (MMF), Prednisone, Tacrolimus, Ganciclovir
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 3 syntheses or guidelines pooled it, 152 citations in OpenAlex.

  1. Pooled it
  2. Steroid avoidance or withdrawal for kidney transplant recipients.The Cochrane database of systematic reviews · 2016
    Pooled it
  3. Pooled it
  4. Trial
  5. The clinical impact of humoral immunity in pediatric renal transplantation.Journal of the American Society of Nephrology : JASN · 2013
    Trial
  6. Subclinical inflammation and chronic renal allograft injury in a randomized trial on steroid avoidance in pediatric kidney transplantation.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2012
    Trial
  7. Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Article
  17. Management of dyslipidemia in pediatric renal transplant recipients.Pediatric nephrology (Berlin, Germany) · 2021
    Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 14 institutions in 3 countries.

M M SarwalCalifornia Pacific Medical Center, Sutter Health Care, San Francisco, CA, USA. sarwalm@cpmcri.org
R B Ettenger
V Dharnidharka
M Benfield
R Mathias
A Portale
R McDonald
W Harmon
D Kershaw
V M Vehaskari
E Kamil
H J Baluarte
B Warady
L Tang
J Liu
L Li
M Naesens
T Sigdel
Janie Waskerwitz
O Salvatierra
California Pacific Medical Center · USStanford University · USPharmaceutical Product Development (India) · INUniversity of California, San Francisco · USCedars-Sinai Medical Center · USChildren's Hospital of New Orleans · USChildren's Hospital of Philadelphia · USChildren's Mercy Hospital · USC. S. Mott Children's Hospital · USHarvard University Press · USMattel Children's Hospital · USSeattle Children's Hospital · USUniversity of Alabama · USUniversity of Florida · US

Funding

New NAPRTCS Trials in Steroid-Free ImmunosuppressionU01AI055795 · NIAID · STANFORD UNIVERSITY · PI SALVATIERRA, OSCAR · 2003 to 2007
$7.8M
NIAID NIH HHS AI-055795NIAID NIH HHS U01 AI055795
6 · The paper itself

Abstract

To determine whether steroid avoidance in pediatric kidney transplantation is safe and efficacious, a randomized, multicenter trial was performed in 12 pediatric kidney transplant centers. One hundred thirty children receiving primary kidney transplants were randomized to steroid-free (SF) or steroid-based (SB) immunosuppression, with concomitant tacrolimus, mycophenolate and standard dose daclizumab (SB group) or extended dose daclizumab (SF group). Follow-up was 3 years posttransplant. Standardized height Z-score change after 3 years follow-up was -0.99 ± 2.20 in SF versus -0.93 ± 1.11 in SB; p = 0.825. In subgroup analysis, recipients under 5 years of age showed improved linear growth with SF compared to SB treatment (change in standardized height Z-score at 3 years -0.43 ± 1.15 vs. -1.07 ± 1.14; p = 0.019). There were no differences in the rates of biopsy-proven acute rejection at 3 years after transplantation (16.7% in SF vs. 17.1% in SB; p = 0.94). Patient survival was 100% in both arms; graft survival was 95% in the SF and 90% in the SB arms (p = 0.30) at 3 years follow-up. Over the 3 year follow-up period, the SF group showed lower systolic BP (p = 0.017) and lower cholesterol levels (p = 0.034). In conclusion, complete steroid avoidance is safe and effective in unsensitized children receiving primary kidney transplants.

Indexed as

Kidney TransplantationAdolescentAdultChildChild, PreschoolFemaleFollow-Up StudiesHumansImmunosuppressive AgentsInfantInfant, NewbornMaleSteroidsYoung AdultImmunosuppressive AgentsSteroids

Identifiers

PMID22694755
PMCPMC3681527
OpenAlexW1946067182

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.