Trial reportAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2020
Challenges of calcineurin inhibitor withdrawal following combined pancreas and kidney transplantation: Results of a prospective, randomized clinical trial.
Trial report in American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01790594 (Optimization of NULOJIX®), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled 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.
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.
Optimization of NULOJIX® (Belatacept) Usage as a Means of Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation (CTOT-15)
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.
- Belatacept in Kidney Transplantation: What Are the True Benefits? A Systematic Review.Frontiers in medicine · 2022Pooled it
- A pilot randomized controlled trial of de novo belatacept-based immunosuppression following anti-thymocyte globulin induction in lung transplantation.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2022Trial
- Belatacept and the Risk of Cytomegalovirus, BK Polyomavirus, and Epstein-Barr Virus Post-transplant Lymphoproliferative Disease After Kidney Transplantation: A Meta-Analysis and Systematic Review.Journal of transplantation · 2026Review
- Belatacept Maintenance Immunosuppression for Calcineurin Inhibitor Sparing or Avoidance in Pancreas Transplant Recipients With Progressive Renal or Renal Allograft Dysfunction.Clinical transplantation · 2025Article
- Development of a Flexible Multiplex Urine RNA Assay for Detection and Differentiation of Kidney Allograft Injury.medRxiv : the preprint server for health sciences · 2025Article
- Real-world evidence regarding cancer, mortality, and graft failure risk with de novo belatacept use among kidney transplant recipients in the United States.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2025Article
- Thrombotic Microangiopathy After Kidney Pancreas Transplant Managed With Eculizumab and a Calcineurin Inhibitor-free Basiliximab/Belatacept Maintenance Regimen: Between a Rock and a Hard Place.Transplantation direct · 2025Article
- The Use of Long-Term Monthly Basiliximab Infusions as Rescue Maintenance Immunosuppression in Pancreas Transplant Recipients.Clinical transplantation · 2024Article
- Belatacept in Pancreas Transplantation: Promising Insights From a Cohort Series.Transplant international : official journal of the European Society for Organ Transplantation · 2024Article
- Belatacept Rescue Therapy in the Early Period After Simultaneous Kidney-Pancreas Transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2024Article
- Costimulatory Blockade and Solid Organ Transplantation: The Past, Present, and Future.Kidney international reports · 2023Review
- First World Consensus Conference on pancreas transplantation: Part II - recommendations.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 5 institutions in 1 country.
Funding
Abstract
In a phase 2 multicenter open-label randomized trial sponsored by the National Institutes of Health, simultaneous pancreas-kidney (SPK) recipients were randomized to a calcineurin inhibitor (CNI)-based immunosuppressive regimen (tacrolimus) (n = 21), or an investigational arm using low-dose CNI plus costimulation blockade (belatacept) with intended CNI withdrawal (n = 22). Both arms included induction therapy with rabbit ATG, mycophenolate sodium, or mycophenolate mofetil and rapid withdrawal of steroids. Enrollment and CNI withdrawal were stopped after 43/60 planned subjects had been enrolled. At that time, the rate of biopsy-proven acute rejection (BPAR) of the pancreas was low in both groups until CNI was withdrawn, with four of the five pancreas rejections occurring during or after CNI withdrawal. The rate of BPAR of kidney allografts was low in both control (9.5%) and investigational (9.1%) arms. Pancreas graft survival at 52 weeks, defined by insulin independence, was 21 (100%) in the control group and 19 (86%) in the investigational arm. One subject in the investigational arm died with functioning pancreas and kidney grafts. Renal function at week 52 was similar in both arms. Costimulation blockade with belatacept did not provide sufficient immunosuppression to reliably prevent pancreas rejection in SPK transplants undergoing CNI withdrawal.
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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.