Evidence map›Paper›PMID 30506630›Full record

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

Outcomes of immunosuppression minimization and withdrawal early after liver transplantation.

Abraham Shaked, Michele R DesMarais, Heather Kopetskie, Sandy Feng, Jeffrey D Punch, Josh Levitsky, Jorge Reyes, Goran B Klintmalm, Anthony J Demetris, Bryna E Burrell and 3 more

Erratum issued 2 registry-linked trialsAbstract readRandomized 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. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 51 papers.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed
–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.

NCT00135694 phase2completednot on this map

A Phase II Trial to Assess the Safety of Immunosuppression Withdrawal in Liver Transplant Recipients

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2005 to 2015Enrolled275ConditionsHepatitis C, Hepatitis C, Chronic, Nonimmune Nonviral Causes of Liver FailureArmscalcineurin inhibitor-based immunosuppression, liver transplant, corticosteroids, immunosuppression withdrawal
NCT05335551 unknown statusnot on this mapstarted 2022, after this paper: background citation

A Clinical Pilot Study to Test the Acceptability and Feasibility of TruGraf Liver and TRAC Liver Testing as Part of Standard of Care: Optimizing Liver ImmunoSuppression (TRU-IMMUNO)

TypeobservationalSponsorTransplant Genomics, Inc.Ran2022 to 2023Enrolled130ConditionsLiver Transplant RejectionArmsPatients monitored with TruGraf and TRAC Liver testing
3 · Its place in the literature

Who cites it

51 citing papers in PubMed.

  1. Trial
  2. Selective decrease of donor-reactive TScience translational medicine · 2022
    Trial
  3. Article
  4. Article
  5. Induction of Clinical Operational Tolerance Through Immunosuppression Minimization: Less Is More?Liver international : official journal of the International Association for the Study of the Liver · 2026
    Review
  6. Review
  7. Article
  8. Side Effects of Immunosuppressant Drugs After Liver Transplant.Pharmaceuticals (Basel, Switzerland) · 2025
    Review
  9. Review
  10. Chimerism-Mediated Tolerance in Intestinal Transplantation.Gastroenterology clinics of North America · 2024
    Review
  11. Article
  12. Proceedings of the 28th Annual Congress of the International Liver Transplantation Society.Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society · 2024
    Article
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Abraham ShakedUniversity of Pennsylvania, Philadelphia, Pennsylvania.
Michele R DesMaraisImmune Tolerance Network, San Francisco, California.
Heather KopetskieRho Federal Systems Division, Chapel Hill, North Carolina.
Sandy FengUniversity of California San Francisco, San Francisco, California.
Jeffrey D PunchUniversity of Michigan, Ann Arbor, Michigan.
Josh LevitskyNorthwestern University, Chicago, Illinois.
Jorge ReyesUniversity of Washington, Seattle, Washington.
Goran B KlintmalmBaylor University Medical Center, Dallas, Texas.
Anthony J DemetrisUniversity of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Bryna E BurrellImmune Tolerance Network, Bethesda, Maryland.
Allison PrioreNational Institutes of Allergy and Infectious Diseases, Bethesda, Maryland.
Nancy D BridgesNational Institutes of Allergy and Infectious Diseases, Bethesda, Maryland.
Peter H SayreImmune Tolerance Network, San Francisco, California.

Funding

Immune Tolerance Network UM1 2023 SupplementUM1AI109565 · NIAID · BENAROYA RESEARCH INST AT VIRGINIA MASON · PI Mark S Anderson, Jane Hoyt Buckner · 2014 to 2026
$451.6M
Transplantation GroupUM2AI117870 · NIAID · RHO FEDERAL SYSTEMS DIVISION, INC. · PI DAVID, GLORIA · 2015 to 2023
$208.1M
NIAID NIH HHS UM1 AI109565NIAID NIH HHS UM2 AI117870
6 · The paper itself

Abstract

The Immune Tolerance Network ITN030ST A-WISH assessed immunosuppression withdrawal in liver transplant recipients with hepatitis C or nonimmune nonviral liver disease. Of 275 recipients enrolled before transplantation, 95 were randomly assigned 4:1 to withdrawal (n = 77) or maintenance (n = 18) 1- to 2-years posttransplant. Randomization eligibility criteria included stable immunosuppression monotherapy; adequate liver and kidney function; ≤Stage 2 Ishak fibrosis; and absence of rejection on biopsy. Immunosuppression withdrawal followed an 8-step reduction algorithm with ≥8 weeks per level. Fifty-two of 77 subjects (67.5%) reduced to ≤50% of baseline dose, and 10 of 77 (13.0%) discontinued all immunosuppression for ≥1 year. Acute rejection and/or abnormal liver tests were treated with increased immunosuppression; 5 of 32 rejection episodes required a methylprednisolone bolus. The composite end point (death or graft loss; grade 4 secondary malignancy or opportunistic infection; Ishak stage ≥3; or >25% decrease in glomerular filtration rate within 24 months of randomization) occurred in 12 of 66 (18%) and 4 of 13 (31%) subjects in the withdrawal and maintenance groups. Early immunosuppression minimization is feasible in selected liver recipients, while complete withdrawal is successful in only a small proportion. The composite end point comparison was inconclusive for noninferiority of the withdrawal to the maintenance group.

Indexed as

AdultFeasibility StudiesFemaleFollow-Up StudiesGraft RejectionGraft SurvivalHumansImmune ToleranceImmunosuppression TherapyImmunosuppressive AgentsLiver DiseasesLiver TransplantationMaleMiddle AgedProspective StudiesRisk FactorsImmunosuppressive Agentsclinical research/practiceclinical trialimmunosuppression/immune modulationimmunosuppressive regimens - minimization/withdrawalinfection and infectious agents - viral: hepatitis Cliver transplantation/hepatologytolerance

Identifiers

PMID30506630
PMCPMC6482056

What OpenQuestion holds

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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.