Evidence map›Paper›PMID 34216395›Full record

Trial reportClinical transplantation2021

Everolimus-facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2-year results from the subgroup analysis of the TRANSFORM study.

Yoshihiko Watarai, Romina Danguilan, Concesa Casasola, Shen-Shin Chang, Prajej Ruangkanchanasetr, Terence Kee, Hin Seng Wong, Takashi Kenmochi, Angel Joaquin Amante, Kuo-Hsiung Shu and 5 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical transplantation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01950819 (A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.9field-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.

NCT01950819 phase4completednot on this map

A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation

TypeinterventionalSponsorNovartis PharmaceuticalsRan2013 to 2018Enrolled2,037ConditionsEnd Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement TherapyArmsInduction therapy, Corticosteroids, EVR+rCNI, MPA+sCNI
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. 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

15 authors at 12 institutions in 8 countries.

Yoshihiko WataraiDepartment of Transplant Surgery, Kidney Disease Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan.
Romina DanguilanDepartment of Adult Nephrology, National Kidney and Transplant Institute, Quezon City, Philippines.
Concesa CasasolaDepartment of Adult Nephrology, National Kidney and Transplant Institute, Quezon City, Philippines.
Shen-Shin ChangDepartment of Surgery, National Cheng Kung University College of Medicine and Hospital, Tainan, Taiwan.
Prajej RuangkanchanasetrDepartment of Medicine, Phramongkutklao Hospital, Bangkok, Thailand.ORCID 0000-0002-5123-5964
Terence KeeDepartment of Renal Medicine, Singapore General Hospital, Singapore, Singapore.ORCID 0000-0001-5250-855X
Hin Seng WongDepartment of Nephrology & Clinical Research Centre Hospital Selayang, Selangor Darul Ehsan, Batu Caves, Malaysia.
Takashi KenmochiDepartment of Transplant Surgery, Fujita Health University Hospital, Toyoake, Japan.
Angel Joaquin AmanteDepartment of Adult Nephrology, National Kidney and Transplant Institute, Quezon City, Philippines.
Kuo-Hsiung ShuDepartment of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.
Atiporn IngsathitDepartment of Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Peter BernhardtDepartment of Research and Development, Novartis Pharma AG, Basel, Switzerland.
Maria Pilar Hernandez-GutierrezDepartment of Research and Development, Novartis Pharma AG, Basel, Switzerland.
Duck Jong HanDepartment of General Surgery, Asan Medical Center, Seoul, Republic of Korea.ORCID 0000-0002-0990-6824
Myoung Soo KimDepartment of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.
National Kidney and Transplant Institute · PHNovartis (Switzerland) · CHAsan Medical Center · KRFujita Health University Hospital · JPHospital Selayang · MYJapanese Red Cross Nagoya Daini Hospital · JPMahidol University · THNational Cheng Kung University Hospital · TWPhramongkutklao Hospital · THSingapore General Hospital · SGTaichung Veterans General Hospital · TWYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe analyzed the efficacy and safety of an everolimus with reduced-exposure calcineurin inhibitor (EVR+rCNI) versus mycophenolic acid with standard-exposure CNI (MPA+sCNI) regimen in Asian patients from the TRANSFORM study.

methodsIn this 24-month, open-label study, de novo kidney transplant recipients (KTxRs) were randomized (1:1) to receive EVR+rCNI or MPA+sCNI, along with induction therapy and corticosteroids.

resultsOf the 2037 patients randomized in the TRANSFORM study, 293 were Asian (EVR+rCNI, N = 136; MPA+sCNI, N = 157). At month 24, EVR+rCNI was noninferior to MPA+sCNI for the binary endpoint of estimated glomerular filtration rate (eGFR) < 50 ml/min/1.73 m

conclusionThis subgroup analysis in Asian de novo KTxRs demonstrated that the EVR+rCNI versus MPA+sCNI regimen provides comparable antirejection efficacy, better renal function, and reduced viral infections (NCT01950819).

Indexed as

Calcineurin InhibitorsKidney TransplantationEverolimusGlomerular Filtration RateGraft RejectionGraft SurvivalHumansImmunosuppressive AgentsMycophenolic AcidTacrolimusCalcineurin InhibitorsEverolimusImmunosuppressive AgentsMycophenolic AcidTacrolimuseverolimuskidney transplantreduced calcineurin inhibitorreduced cyclosporinereduced tacrolimus

Identifiers

PMID34216395
PMCPMC9255374
OpenAlexW3174839794

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.