Evidence map›Paper›PMID 30582281›Full record

Trial reportAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2019

Comparison of the effects of standard vs low-dose prolonged-release tacrolimus with or without ACEi/ARB on the histology and function of renal allografts.

Sandra M Cockfield, Sam Wilson, Patricia M Campbell, Marcelo Cantarovich, Azim Gangji, Isabelle Houde, Anthony M Jevnikar, Tammy M Keough-Ryan, Felix-Mauricio Monroy-Cuadros, Peter W Nickerson and 8 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, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00933231 (A Comparison of Effects of Standard Dose vs. Low Dose Advagraf® With IL-2 Receptor Antibody Induction, MMF and Steroids, With or Without ACEi/ARB - Based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune Response), which is not on this map. Cited by 20 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 4 pooled it
2.3field-weighted citation impact, top 11% 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.

NCT00933231 phase3completednot on this map

A Comparison of Effects of Standard Dose vs. Low Dose Advagraf® With IL-2 Receptor Antibody Induction, MMF and Steroids, With or Without ACEi/ARB - Based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune Response

TypeinterventionalSponsorAstellas Pharma IncRan2009 to 2018Enrolled281ConditionsKidney TransplantationArmstacrolimus, Simulect, Cellcept, Corticosteroids, Ramipril
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 4 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Antihypertensive treatment for kidney transplant recipients.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Comparison of the effects of standard vs low-dose prolonged-release tacrolimus with or without ACEi/ARB on the histology and function of renal allografts.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2019
    Trial
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. The negative impact of T cell-mediated rejection on renal allograft survival in the modern era.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2022
    Observational
  17. Article
  18. Proposed Definitions of T Cell-Mediated Rejection and Tubulointerstitial Inflammation as Clinical Trial Endpoints in Kidney Transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2022
    Article
  19. Article
  20. A noninferiority design for a delayed calcineurin inhibitor substitution trial in kidney transplantation.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2021
    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

18 authors at 15 institutions in 2 countries.

Sandra M CockfieldUniversity of Alberta Hospital, Edmonton, Alberta, Canada.
Sam WilsonAstellas Pharma Global Development, Northbrook, Illinois.
Patricia M CampbellUniversity of Alberta Hospital, Edmonton, Alberta, Canada.
Marcelo CantarovichMcGill University Health Centre, Montreal, Québec, Canada.
Azim GangjiSt. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.
Isabelle HoudeL'Hôtel-Dieu de Quebec, Quebec City, Québec, Canada.
Anthony M JevnikarLondon Health Sciences Centre, London, Ontario, Canada.
Tammy M Keough-RyanQueen Elizabeth II, HSC, Halifax, Nova Scotia, Canada.
Felix-Mauricio Monroy-CuadrosFoothills Medical Centre, Calgary, Alberta, Canada.
Peter W NickersonHealth Sciences Centre, Winnipeg, Manitoba, Canada.
Michel R PâquetHôpital Notre-Dame du CHUM, Montreal, Québec, Canada.
G V Ramesh PrasadSt. Michael's Hospital, Toronto, Ontario, Canada.
Lynne SenécalHôpital Maisonneuve-Rosemont, Montreal, Québec, Canada.
Ahmed ShokerSt. Paul's Hospital, Saskatoon, Saskatchewan, Canada.
Jean-Luc WolffCentre Hospitalier Universitaire, Sherbrooke, Québec, Canada.
John HowellAstellas Pharma Global Development, Inc., Markham, Ontario, Canada.
Jason J SchwartzAstellas Pharma Global Development, Northbrook, Illinois.
David N RushHealth Sciences Centre, Winnipeg, Manitoba, Canada.
Astellas Pharma (United States) · USHealth Sciences Centre · CAAlberta Hospital Edmonton · CACentre Hospitalier Universitaire de Sherbrooke · CAFoothills Medical Centre · CAHôpital Maisonneuve-Rosemont · CAHôpital Notre-Dame · CAHôtel-Dieu de Québec · CALondon Health Sciences Centre · CAMcGill University Health Centre · CAQueen Elizabeth II Health Sciences Centre · CASt. Joseph’s Healthcare Hamilton · CASt. Michael's Hospital · CASt. Paul's Hospital · CAUniversity of Alberta Hospital · CA

Funding

Astellas Pharma, Inc
6 · The paper itself

Abstract

Targeting the renin-angiotensin system and optimizing tacrolimus exposure are both postulated to improve outcomes in renal transplant recipients (RTRs) by preventing interstitial fibrosis/tubular atrophy (IF/TA). In this multicenter, prospective, open-label controlled trial, adult de novo RTRs were randomized in a 2 × 2 design to low- vs standard-dose (LOW vs STD) prolonged-release tacrolimus and to angiotensin-converting enzyme inhibitors/angiotensin II receptor 1 blockers (ACEi/ARBs) vs other antihypertensive therapy (OAHT). There were 2 coprimary endpoints: the prevalence of IF/TA at month 6 and at month 24. IF/TA prevalence was similar for LOW vs STD tacrolimus at month 6 (36.8% vs 39.5%; P = .80) and ACEi/ARBs vs OAHT at month 24 (54.8% vs 58.2%; P = .33). IF/TA progression decreased significantly with LOW vs STD tacrolimus at month 24 (mean [SD] change, +0.42 [1.477] vs +1.10 [1.577]; P = .0039). Across the 4 treatment groups, LOW + ACEi/ARB patients exhibited the lowest mean IF/TA change and, compared with LOW + OAHT patients, experienced significantly delayed time to first T cell-mediated rejection. Renal function was stable from month 1 to month 24 in all treatment groups. No unexpected safety findings were detected. Coupled with LOW tacrolimus dosing, ACEi/ARBs appear to reduce IF/TA progression and delay rejection relative to reduced tacrolimus exposure without renin-angiotensin system blockade. ClinicalTrials.gov identifier: NCT00933231.

Indexed as

AdultAllograftsAngiotensin-Converting Enzyme InhibitorsAngiotensin II Type 1 Receptor BlockersAtrophyDelayed-Action PreparationsDrug Therapy, CombinationFemaleFibrosisGraft RejectionHumansImmunosuppressive AgentsKidneyKidney TransplantationMaleMiddle AgedAngiotensin-Converting Enzyme InhibitorsAngiotensin II Type 1 Receptor BlockersDelayed-Action PreparationsImmunosuppressive AgentsTacrolimusclinical research/practiceclinical trialgraft survivalimmunosuppressant - calcineurin inhibitor: tacrolimusimmunosuppression/immune modulationkidney transplantation/nephrologyorgan transplantation in generalpatient survival

Identifiers

PMID30582281
PMCPMC6590452
OpenAlexW2906178356

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.