Evidence map›Paper›PMID 36875940›Full record

ArticleTransplantation direct2023

Long-term Prolonged-release Tacrolimus-based Immunosuppression in De Novo Kidney Transplant Recipients: 5-Y Prospective Follow-up of Patients in the ADVANCE Study.

Vincent Pernin, Maciej Glyda, Ondrej Viklický, Aleksander Lõhmus, Lars Wennberg, Oliver Witzke, Bengt von Zur-Mühlen, Swapneel Anaokar, Martin Hurst, Gbenga Kazeem and 2 more

Open access · goldAbstract read
In one paragraph

Article in Transplantation direct, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 29% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
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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

12 authors at 4 institutions in 3 countries.

Vincent PerninDepartment of Nephrology, Dialysis and Transplantation, Hôpital Lapeyronie, University of Montpellier, Montpellier, France.
Maciej GlydaDepartment of Transplantology and Surgery, District Public Hospital Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Bydgoszcz, Poland.
Ondrej ViklickýDepartment of Nephrology, Transplant Center, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
Aleksander LõhmusDepartment of Urology and Kidney Transplantation, Clinic of Surgery, Tartu University Hospital, Tartu, Estonia.
Lars WennbergDepartment of Transplantation Surgery, Karolinska University Hospital, Stockholm, Sweden.
Oliver WitzkeDepartment of Infectious Diseases, West German Centre of Infectious Diseases, University Hospital Essen, University Duisberg-Essen, Germany.
Bengt von Zur-MühlenDepartment of Surgical Sciences, Division of Transplantation Surgery, Uppsala University Hospital, Uppsala, Sweden.
Swapneel AnaokarMedical Affairs, Astellas Pharma Europe, Chertsey, United Kingdom.
Martin HurstMedical Affairs, Astellas Pharma Europe, Chertsey, United Kingdom.
Gbenga KazeemMedical Affairs, Astellas Pharma Europe, Chertsey, United Kingdom.
Nasrullah UndreMedical Affairs, Astellas Pharma Europe, Chertsey, United Kingdom.
Dirk R J KuypersDepartment of Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium.
Institute of Clinical and Experimental Medicine · CZKarolinska University Hospital · SEKU Leuven · BEUppsala University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Although prolonged-release tacrolimus (PR-T) is widely approved for posttransplantation immunosuppression in kidney recipients, large-scale studies are required to assess long-term outcomes. We present follow-up data from the Advagraf-based Immunosuppression Regimen Examining New Onset Diabetes Mellitus in Kidney Transplant Recipients (ADVANCE) trial, in which kidney transplant patients (KTPs) received corticosteroid minimization with PR-T. Methods: ADVANCE was a 24-wk, randomized, open-label, phase-4 study. De novo KTPs received PR-T with basiliximab and mycophenolate mofetil and were randomized to receive an intraoperative corticosteroid bolus plus tapered corticosteroids until day 10 (arm 1) or an intraoperative corticosteroid bolus (arm 2). In this 5-y, noninterventional follow-up, patients received maintenance immunosuppression according to standard practice. The primary endpoint was graft survival (Kaplan-Meier). Secondary endpoints included patient survival, biopsy-confirmed acute rejection-free survival, and estimated glomerular filtration rate (4-variable modification of diet in renal disease). Results: Follow-up study included 1125 patients. Overall graft survival at 1 and 5 y posttransplantation was 93.8% and 88.1%, respectively, and was similar between treatment arms. At 1 and 5 y, patient survival was 97.8% and 94.4%, respectively. Five-year graft and patient survival rates in KTPs who remained on PR-T were 91.5% and 98.2%, respectively. Cox proportional hazards analysis demonstrated similar risk of graft loss and death between treatment arms. Five-year biopsy-confirmed acute rejection-free survival was 84.1%. Mean ± standard deviation values of estimated glomerular filtration rate were 52.7 ± 19.5 and 51.1 ± 22.4 mL/min/1.73 m Conclusions: Graft survival and patient survival (overall and for KTPs who remained on PR-T) were numerically high and similar between treatment arms at 5 y posttransplantation.

Identifiers

PMID36875940
PMCPMC9977488
OpenAlexW4319661315

What OpenQuestion holds

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Registered trials

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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.