Evidence mapPaperPMID 32019854Full record

Trial reportDiabetes care2020

Targeting CXCR1/2 Does Not Improve Insulin Secretion After Pancreatic Islet Transplantation: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial in Type 1 Diabetes.

Paola Maffi, Torbjörn Lundgren, Gunnar Tufveson, Ehab Rafael, James A M Shaw, Aaron Liew, Frantisek Saudek, Piotr Witkowski, Karolina Golab, Federico Bertuzzi and 5 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01817959 (A Phase 3, Multicenter, Randomized, Double-blind, Parallel Assignment Study to Assess the Efficacy and Safety of Reparixin in Pancreatic Islet Transplantation), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
8.2field-weighted citation impact, top 2% 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.

NCT01817959 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Parallel Assignment Study to Assess the Efficacy and Safety of Reparixin in Pancreatic Islet Transplantation

TypeinterventionalSponsorDompé Farmaceutici S.p.ARan2012 to 2017Enrolled51ConditionsIslet Transplantation in Diabetes Mellitus Type 1ArmsReparixin, Placebo
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Therapeutic inhibition of CXCR1/2: where do we stand?Internal and emergency medicine · 2023
    Review
  10. Review
  11. Enhancing Beta Cell Replacement Therapies: Exploring Calcineurin Inhibitor-Sparing Immunosuppressive Regimens.Transplant international : official journal of the European Society for Organ Transplantation · 2023
    Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. Review
  17. Article
  18. COVID-19 and islet transplantation: Different twins.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2020
    Review
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 10 institutions in 5 countries.

Paola MaffiSan Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.
Torbjörn LundgrenDepartment of Clinical Science, Intervention and Technology, Karolinska Institutet, Karolinska, Sweden.
Gunnar TufvesonUppsala University, Uppsala, Sweden.
Ehab RafaelSkåne University Hospital, Malmö, Sweden.
James A M ShawInstitute of Cellular Medicine, Newcastle University, and Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, U.K.
Aaron LiewInstitute of Cellular Medicine, Newcastle University, and Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, U.K.
Frantisek SaudekInstitute for Clinical and Experimental Medicine, Prague, Czech Republic.
Piotr WitkowskiTransplantation Institute, University of Chicago Medicine, Chicago, IL.
Karolina GolabTransplantation Institute, University of Chicago Medicine, Chicago, IL.
Federico BertuzziOspedale Niguarda Ca' Granda, Milan, Italy.
Bengt GustafssonUniversity of Gothenburg, Göteborg, Sweden.
Luisa DaffonchioResearch and Development Department, Dompé farmaceutici S.p.A., Milan, Italy.
Pier Adelchi RuffiniResearch and Development Department, Dompé farmaceutici S.p.A., Milan, Italy.
Lorenzo PiemontiSan Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy piemonti.lorenzo@hsr.it.
REP0211 Study GroupORCID 0000-0002-2172-2198
Dompé (Italy) · ITIRCCS Ospedale San Raffaele · ITNewcastle upon Tyne Hospitals NHS Foundation Trust · GBUniversity of Chicago · USAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITInstitute of Clinical and Experimental Medicine · CZKarolinska Institutet · SESkåne University Hospital · SEUniversity of Gothenburg · SEUppsala University · SE

Funding

Physiology CoreP30DK020595 · UNIVERSITY OF CHICAGO · 2025 to 2025
$1.4M
NIDDK NIH HHS P30 DK020595
6 · The paper itself

Abstract

objectiveReparixin is an inhibitor of CXCR1/2 chemokine receptor shown to be an effective anti-inflammatory adjuvant in a pilot clinical trial in allotransplant recipients. RESEARCH DESIGN AND

methodsA phase 3, multicenter, randomized, double-blind, parallel-assignment study (NCT01817959) was conducted in recipients of islet allotransplants randomized (2:1) to reparixin or placebo in addition to immunosuppression. Primary outcome was the area under the curve (AUC) for C-peptide during the mixed-meal tolerance test at day 75 ± 5 after the first and day 365 ± 14 after the last transplant. Secondary end points included insulin independence and standard measures of glycemic control.

resultsThe intention-to-treat analysis did not show a significant difference in C-peptide AUC at both day 75 (27 on reparixin vs. 18 on placebo,

conclusionsIn this first double-blind randomized trial, islet transplantation data obtained with reparixin do not support a role of CXCR1/2 inhibition in preventing islet inflammation-mediated damage.

Indexed as

Islets of Langerhans TransplantationAdolescentAdultAgedCombined Modality TherapyDiabetes Mellitus, Type 1Double-Blind MethodDrug Administration ScheduleFemaleHumansImmunosuppressive AgentsInsulin SecretionMaleMiddle AgedPlacebosPostoperative PeriodImmunosuppressive AgentsPlacebosReceptors, Interleukin-8AReceptors, Interleukin-8BreparixinSulfonamides

Identifiers

PMID32019854
PMCPMC7876579
OpenAlexW3004777863

What Socratic holds

Textmetadata
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 Socratic graph.