Evidence map›Paper›PMID 22694733›Full record

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

Subclinical inflammation and chronic renal allograft injury in a randomized trial on steroid avoidance in pediatric kidney transplantation.

M Naesens, O Salvatierra, M Benfield, R B Ettenger, V Dharnidharka, W Harmon, R Mathias, M M Sarwal, SNS01-NIH-CCTPT Multicenter Trial

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 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
4.1field-weighted citation impact, top 6% 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

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.

  1. Steroid avoidance or withdrawal for kidney transplant recipients.The Cochrane database of systematic reviews · 2016
    Pooled it
  2. Subclinical inflammation phenotypes and long-term outcomes after pediatric kidney transplantation.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2018
    Trial
  3. The clinical impact of humoral immunity in pediatric renal transplantation.Journal of the American Society of Nephrology : JASN · 2013
    Trial
  4. Complete steroid avoidance is effective and safe in children with renal transplants: a multicenter randomized trial with three-year follow-up.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2012
    Trial
  5. Article
  6. Article
  7. A Peripheral Blood Gene Expression Signature to Diagnose Subclinical Acute Rejection.Journal of the American Society of Nephrology : JASN · 2019
    Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Polyclonal Regulatory T Cell Therapy for Control of Inflammation in Kidney Transplants.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2017
    Article
  13. Biomarkers in renal transplantation: An updated review.World journal of transplantation · 2017
    Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Challenges in pediatric renal transplantation.World journal of transplantation · 2014
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 8 institutions in 2 countries.

M NaesensDepartment of Nephrology and Renal Transplantation, University Hospitals Leuven, Belgium.
O Salvatierra
M Benfield
R B Ettenger
V Dharnidharka
W Harmon
R Mathias
M M Sarwal
SNS01-NIH-CCTPT Multicenter Trial
California Pacific Medical Center · USHarvard University · USMattel Children's Hospital · USStanford University · USSutter Health · USUniversity of Alabama at Birmingham · USUniversity of California San Francisco Medical Center · USUniversity of Florida · US

Funding

UF Clinical and Translational Science AwardUL1TR000064 · NCATS · UNIVERSITY OF FLORIDA · PI NELSON, DAVID R · 2012 to 2014
$12.2M
New NAPRTCS Trials in Steroid-Free ImmunosuppressionU01AI055795 · NIAID · STANFORD UNIVERSITY · PI SALVATIERRA, OSCAR · 2003 to 2007
$7.8M
NCATS NIH HHS UL1 TR000064NIAID NIH HHS AI-055795NIAID NIH HHS U01 AI055795
6 · The paper itself

Abstract

Steroid avoidance is safe and effective in children receiving kidney transplants in terms of graft function and survival, but the effects on allograft histology are unknown. In this multicenter trial, 130 pediatric renal transplant recipients were randomized to steroid-free (SF; n = 60) or steroid-based (SB; n = 70) immunosuppression, and underwent renal allograft biopsies at the time of graft dysfunction and per protocol at implantation and 6, 12 and 24 months after transplantation. Clinical follow-up was 3 years posttransplant. Subclinical acute rejection was present in 10.6% SF versus 11.3% SB biopsies at 6 months (p = 0.91), 0% SF versus 4.3% SB biopsies at 1 year (p = 0.21) and 0% versus 4.8% at 2 years (p = 0.20). Clinical acute rejection was present in 13.3% SF and 11.4% SB patients by 1 year (p = 0.74) and in 16.7% SF and 17.1% SB patients by 3 years (p = 0.94) after transplantation. The cumulative incidence of antibody-mediated rejection was 6.7% in SF and 2.9% in SB by 3 years after transplantation (p = 0.30). There was a significant increase in chronic histological damage over time (p < 0.001), without difference between SF and SB patients. Smaller recipient size and higher donor age were the main risk factors for chronic histological injury in posttransplant biopsies.

Indexed as

AdolescentChildFemaleGraft RejectionHumansImmunosuppressive AgentsKidney TransplantationMaleSteroidsImmunosuppressive AgentsSteroids

Identifiers

PMID22694733
PMCPMC3459071
OpenAlexW1542847513

What OpenQuestion holds

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LicenceTDM
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.