Evidence map›Paper›PMID 23279614›Full record

Trial reportAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2013

Conversion from twice-daily tacrolimus to once-daily extended release tacrolimus (LCPT): the phase III randomized MELT trial.

S Bunnapradist, K Ciechanowski, P West-Thielke, S Mulgaonkar, L Rostaing, B Vasudev, K Budde, MELT investigators

5 registry-linked trialsAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
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, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 38 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 2 pooled it
–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.

NCT03555448 phase4terminatednot on this mapstarted 2018, after this paper: background citation

Once a Day Immunosuppression Regimen: Outcomes and Compliance

TypeinterventionalSponsorWashington University School of MedicineRan2018 to 2023Enrolled51ConditionsKidney Transplant, ComplicationsArmsOnce daily immunosuppression regimen, Twice daily immunosuppression regimen
NCT04225988 phase4completednot on this mapstarted 2020, after this paper: background citation

A Prospective, Pilot Trial to Compare the Efficacy of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release on Suppression of Donor-Specific Antibodies in HLA Sensitized Kidney Transplant Recipients

TypeinterventionalSponsorCedars-Sinai Medical CenterRan2020 to 2023Enrolled20ConditionsKidney Transplant RejectionArmsExtended-release tacrolimus, Immediate-release tacrolimus
NCT04469842 early_phase1recruitingnot on this mapstarted 2023, after this paper: background citation

A Prospective, Randomized, Controlled Pilot Study of Early-Use Long Acting Tacrolimus (Envarsus XR) in Lung Transplant Recipients

TypeinterventionalSponsorVanderbilt University Medical CenterRan2023 to 2027Enrolled48ConditionsLung Transplant, ComplicationsArmsTacrolimus Extended Release Oral Tablet [Envarsus], Tacrolimus, Mycophenolate Mofetil Hydrochloride, Prednisone, Azathioprine
NCT04665310 phase4active not recruitingnot on this mapstarted 2018, after this paper: background citation

Evaluation of Early Dose Escalation Using Extended-Release Tacrolimus (Envarsus XR®) to Reduce Acute Rejection and Donor Specific Antibodies in African American Renal Transplant Recipients

TypeinterventionalSponsorThe Methodist Hospital Research InstituteRan2018 to 2025Enrolled46ConditionsKidney Disease, End-Stage, Donor Specific Antibodies, Acute Rejection of Renal TransplantArmsEnvarsus XR
NCT04917718 phase4unknown statusnot on this mapstarted 2021, after this paper: background citation

Assessment of Renal Tubular Injury and Transplant Outcomes in Cardiac Recipients Converting From Immediate Release Tacrolimus to Extended Release Tacrolimus.

TypeinterventionalSponsorLoyola UniversityRan2021 to 2024Enrolled42ConditionsChronic Kidney Diseases, Heart TransplantArmsConversion from IR Tacrolimus to XR Tacrolimus
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Prolonged-Release Once-Daily Formulation of Tacrolimus Versus Standard-of-Care Tacrolimus inTransplant international : official journal of the European Society for Organ Transplantation · 2022
    Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. A Steady-State Head-to-Head Pharmacokinetic Comparison of All FK-506 (Tacrolimus) Formulations (ASTCOFF): An Open-Label, Prospective, Randomized, Two-Arm, Three-Period Crossover Study.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2017
    Trial
  10. Trial
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Observational
  20. Impact of Converting from Immediate-Release Tacrolimus to Envarsus on BK Viremia Incidence in Kidney Transplant Patients with Rapid Metabolism.Medical science monitor : international medical journal of experimental and clinical research · 2023
    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

8 authors.

S BunnapradistDavid Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Bunnapradist@mednet.ucla.edu
K Ciechanowski
P West-Thielke
S Mulgaonkar
L Rostaing
B Vasudev
K Budde
MELT investigators

Funding

Clincal and Translational Science AwardUL1TR000055 · NCATS · MEDICAL COLLEGE OF WISCONSIN · PI SHAKER, REZA NONE · 2012 to 2015
$11.3M
NCATS NIH HHS UL1 TR000055
6 · The paper itself

Abstract

Phase III noninferiority trial examining efficacy and safety of converting stable renal transplant recipients from twice-daily tacrolimus to a novel extended-release once-daily tacrolimus formulation (LCPT) with a controlled agglomeration technology. Controls maintained tacrolimus twice daily. The primary efficacy endpoint was proportion of patients with efficacy failures (death, graft failure, locally read biopsy-proven acute rejection [BPAR], or loss to follow-up) within 12 months. Starting LCPT dose was 30% lower (15% for blacks) than preconversion tacrolimus dose; target trough levels were 4-15 ng/mL. A total of 326 patients were randomized; the mITT population (n = 162 each group) was similar demographically in the two groups. Mean daily dose of LCPT was significantly (p < 0.0001) lower than preconversion tacrolimus dose at each visit; mean trough levels between groups were similar. There were four efficacy failures in each group; safety outcomes were similar between groups. Frequency of premature study drug discontinuation was LCPT: 12% versus tacrolimus twice daily: 5% (p = 0.028). LCPT demonstrated noninferiority to tacrolimus twice daily in efficacy failure rates. LCPT may offer a safe and effective alternative for converting patients to a once-daily formulation. Compared to currently available tacrolimus formulation, LCPT requires lower doses to achieve target trough levels.

Indexed as

Drug Administration ScheduleFemaleFollow-Up StudiesGraft RejectionGraft SurvivalHumansImmunosuppressive AgentsKidney DiseasesKidney TransplantationMaleMiddle AgedPostoperative ComplicationsPrognosisProspective StudiesTacrolimusImmunosuppressive AgentsTacrolimus

Identifiers

PMID23279614
PMCPMC3613750

What OpenQuestion holds

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LicenceCC BY
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.