Evidence map›Paper›PMID 33859155›Full record

Trial reportAnnals of transplantation2021

Efficacy and Safety of Once-Daily LCP-Tacrolimus Versus Twice-Daily Immediate-Release Tacrolimus in Adult Hispanic Stable Kidney Transplant Recipients: Sub-Group Analysis from a Phase 3 Trial.

Arman Faravardeh, Sanjeev Akkina, Rafael Villicana, Giselle Guerra, Misbah A Moten, Ulf Meier-Kriesche, Daniel R Stevens, Samir J Patel, Suphamai Bunnapradist

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of 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 NCT00817206 (Ph3, Open Label, Multi-Ctr, Pros, Rand Study -Efficacy and Safety, Conversion Prograf® Capsules BID to LCPTacro Tablets QD, for Prevent of Acute Allograft Rejection in Stable Kidney Transplant pt.), which is not on this map. Cited by 2 papers.

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

NCT00817206 phase3completednot on this map

Ph3, Open Label, Multi-Ctr, Pros, Rand Study -Efficacy and Safety, Conversion Prograf® Capsules BID to LCPTacro Tablets QD, for Prevent of Acute Allograft Rejection in Stable Kidney Transplant pt.

TypeinterventionalSponsorVeloxis PharmaceuticalsRan2008 to 2011Enrolled326ConditionsRenal FailureArmsLCP-Tacro, Prograf
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. 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

9 authors at 4 institutions in 1 country.

Arman FaravardehSHARP Kidney and Pancreas Transplant Center, San Diego, CA, USA.
Sanjeev AkkinaLoyola Outpatient Center, Loyola University Medical Center, Maywood, IL, USA.
Rafael VillicanaLoma Linda University Transplant Institute, Loma Linda University Health, Loma Linda, CA, USA.
Giselle GuerraMiami Transplant Institute, University of Miami Health System, Miami, FL, USA.
Misbah A MotenDepartment of Medical Affairs, Veloxis Pharmaceuticals, Cary, NC, USA.
Ulf Meier-KriescheDepartment of Medical Affairs, Veloxis Pharmaceuticals, Cary, NC, USA.
Daniel R StevensDepartment of Medical Affairs, Veloxis Pharmaceuticals, Cary, NC, USA.
Samir J PatelDepartment of Medical Affairs, Veloxis Pharmaceuticals, Cary, NC, USA.
Suphamai BunnapradistDepartment of Medicine, Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA.
Loma Linda University · USLoyola University Medical Center · USMiami Transplant Institute · USRonald Reagan UCLA Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND The pharmacokinetics and metabolism of tacrolimus, an immunosuppressant commonly used to prevent transplant rejection, can differ in specific subpopulations. This analysis examined treatment outcomes and safety of immediate-release tacrolimus (IR-Tac) and LCP-tacrolimus (LCPT) in stable Hispanic kidney transplant recipients. MATERIAL AND METHODS This was a post hoc analysis of clinical trial data from Hispanic adult stable kidney transplant recipients randomized to remain on IR-Tac or convert from IR-Tac to a reduced dose of LCPT (NCT00817206). Composite treatment failure was evaluated at 12 months. Estimated glomerular filtration rate and tacrolimus trough concentrations were evaluated over 12 months. RESULTS Fifty-five stable (LCPT n=26, IR-Tac n=29) kidney transplant recipients who self-identified as Hispanic or Latino were included in this analysis. Composite treatment failure occurred in 1 patient (4%) who converted to LCPT and 1 (3%) who remained on IR-Tac. The estimated glomerular filtration rate was stable over time and similar in the 2 treatment groups (P=0.08). Tacrolimus trough levels for both groups were similar over time in the 2 treatment groups (P=0.98). Treatment-emergent adverse events were similar in patients who converted to LCPT and in those who remained on IR-Tac. CONCLUSIONS Efficacy and safety were similar in Hispanic kidney transplant recipients who converted from IR-Tac to LCPT and in those remaining on IR-Tac.

Indexed as

Immunosuppressive AgentsKidney TransplantationTacrolimusAdultDrug Administration ScheduleFemaleGraft RejectionHispanic or LatinoHumansMaleMiddle AgedTransplant RecipientsImmunosuppressive AgentsTacrolimus

Identifiers

PMID33859155
PMCPMC8056872
OpenAlexW3139318521

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.