Trial reportJournal of the American Society of Nephrology : JASN2015
Adverse Outcomes of Tacrolimus Withdrawal in Immune-Quiescent Kidney Transplant Recipients.
Trial report in Journal of the American Society of Nephrology : JASN, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01517984 (Immune Monitoring and Calcineurin Inhibitor), which is not on this map. Cited by 83 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Immune Monitoring and Calcineurin Inhibitor (CNI) Withdrawal in Low Risk Recipients of Kidney Transplantation
Who cites it
83 citing papers in PubMed, 1 synthesis or guideline pooled it, 187 citations in OpenAlex.
- Calcineurin inhibitor withdrawal or tapering for kidney transplant recipients.The Cochrane database of systematic reviews · 2017Pooled it
- Peripheral Blood Immune Cell Composition After Autologous MSC Infusion in Kidney Transplantation Recipients.Transplant international : official journal of the European Society for Organ Transplantation · 2023Trial
- The effect of the very low dosage diltiazem on tacrolimus exposure very early after kidney transplantation: a randomized controlled trial.Scientific reports · 2022Trial
- Case Report: Long-term observations from the tacrolimus weaning randomized clinical trial depicts the challenging aspects for determination of low-immunological risk patients.Frontiers in immunology · 2022Trial
- Avoidance of CNI and steroids using belatacept-Results of the Clinical Trials in Organ Transplantation 16 trial.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2020Trial
- Distinct peripheral blood molecular signature emerges with successful tacrolimus withdrawal in kidney transplant recipients.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2020Trial
- Holding On or Letting Go: Immunosuppression After Pediatric Kidney Allograft Failure.Pediatric transplantation · 2026Review
- Conference Report-The Past, Current, and Future Challenges in Transplantation: A Festschrift in Honor of Professor Paul Anthony Keown.Canadian journal of kidney health and disease · 2026Article
- Tertiary lymphoid organ-associated transcriptomic features predict rejection and outcome in kidney transplantation: integrative analysis and experimental validation.Clinical and experimental medicine · 2025Article
- Noninvasive Diagnosis of Kidney Allograft Rejection.Journal of the American Society of Nephrology : JASN · 2025Review
- Non-Induction Basiliximab to Facilitate Renal Recovery via Temporary Tacrolimus Cessation in Cardiothoracic Transplant Patients.Medicines (Basel, Switzerland) · 2025Article
- Combination Automated Microfluidics Measurement of Urine C-C Motif Ligand 2, CXC-Motif Chemokine 9, CXC-Motif Chemokine 10, and Vascular Endothelial Growth Factor A for Monitoring Patients with a Kidney Transplant.Clinical journal of the American Society of Nephrology : CJASN · 2025Article
- The Progress and Challenges of Implementing HLA Molecular Matching in Clinical Practice.Transplant international : official journal of the European Society for Organ Transplantation · 2025Review
- The Role of Topical Tacrolimus in the Management of Inflammatory Bowel Disease: A Comprehensive Review.Journal of clinical medicine · 2024Review
- Long-Term Outcome after Early Mammalian Target of Rapamycin Inhibitor-Based Immunosuppression in Kidney Transplant Recipients.Journal of clinical medicine · 2024Article
- Impact of Immunosenescence in Older Kidney Transplant Recipients: Associated Clinical Outcomes and Possible Risk Stratification for Immunosuppression Reduction.Drugs & aging · 2024Review
- Editorial: Management of patients with a failed kidney transplant: perspectives from transplant nephrologist, infectious disease, immunogenetics, oncology and transplant surgeons.Frontiers in nephrology · 2024Article
- HLA class, calcineurin inhibitor levels, and the risk of graft failure in kidney recipients withFrontiers in immunology · 2024Article
- The aging of the immune system and its implications for transplantation.GeroScience · 2023Review
- Molecular immune monitoring in kidney transplant rejection: a state-of-the-art review.Frontiers in immunology · 2023Review
23 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
20 authors at 12 institutions in 2 countries.
Funding
Abstract
Concerns about adverse effects of calcineurin inhibitors (CNIs) have prompted development of protocols that minimize their use. Whereas previous CNI withdrawal trials in heterogeneous cohorts showed unacceptable rates of acute rejection (AR), we hypothesized that we could identify individuals capable of tolerating CNI withdrawal by targeting immunologically quiescent kidney transplant recipients. The Clinical Trials in Organ Transplantation-09 Trial was a randomized, prospective study of nonsensitized primary recipients of living donor kidney transplants. Subjects received rabbit antithymocyte globulin, tacrolimus, mycophenolate mofetil, and prednisone. Six months post-transplantation, subjects without de novo donor-specific antibodies (DSAs), AR, or inflammation at protocol biopsy were randomized to wean off or remain on tacrolimus. The intended primary end point was the change in interstitial fibrosis/tubular atrophy score between implantation and 24-month protocol biopsies. Serially collected urine CXCL9 ELISA results were correlated with outcomes. The study was terminated prematurely because of unacceptable rates of AR (4 of 14) and/or de novo DSAs (5 of 14) in the tacrolimus withdrawal arm. Positive urinary CXCL9 predated clinical detection of AR by a median of 15 days. Analyses showed that >16 HLA-DQ epitope mismatches and pretransplant, peripheral blood, donor-reactive IFN-γ ELISPOT assay results correlated with development of DSAs and/or AR on tacrolimus withdrawal. Although data indicate that urinary CXCL9 monitoring, epitope mismatches, and ELISPOT assays are potentially informative, complete CNI withdrawal must be strongly discouraged in kidney transplant recipients who are receiving standard-of-care immunosuppression, including those who are deemed to be immunologically quiescent on the basis of current clinical and laboratory criteria.
Indexed as
Identifiers
What OpenQuestion holds
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.