REP0211A Phase 3, Multicenter, Randomized, Double-blind, Parallel Assignment Study to Assess the Efficacy and Safety of Reparixin in Pancreatic Islet Transplantation
Reparixin
+ Placebo
Maladies Auto-immunes+5
+ Diabète Mellitus
+ Maladies du système endocrinien
Étude de prévention
Résumé
Date de début de l'étude : 1 octobre 2012
Date à laquelle le premier participant a commencé l'étude.Pancreatic islet transplantation has become a feasible option in the treatment of T1D which offers advantages over whole pancreas transplantation. Several strategies are being evaluated, including anti-TNFα, aimed to prevent early inflammatory events that limit islet engraftment. Among possible mechanisms CXCL8 could play a crucial role in triggering the inflammatory reaction and might represent a relevant therapeutic target to prevent early graft failure. Preliminary data obtained in transplanted patients recruited in the ongoing pilot trial coupled with the safety shown in human phase 1 and 2 studies provide a sound rationale for further development of reparixin in islet transplantation and prompted the conduct of this phase 3 clinical, multicentre, randomised, double-blind, parallel assignment study aimed at assessing the efficacy and safety of reparixin in preventing graft dysfunction after islet transplantation in T1D subjects. At least 42 patients receiving pancreatic islet transplant were involved. Patients might receive up to 2 islet transplants, with the second transplant on average 6 months after the first one. Patients were randomly (2:1) assigned to receive either reparixin or placebo (control group). The Investigational Product was administered as an added on treatment to the immunosuppressant regimen.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.51 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Prévention
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 70 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: Ages 18-70 years, inclusive. Patients eligible for a pancreatic islet transplantation program Planned intrahepatic islet transplantation alone from a non-living donor with brain death. Patients willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations. Patients who have given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. Exclusion Criteria: Recipients of any previous transplant, including recipients of previous pancreatic islet transplantation. Recipients of islet from a non-heart beating donor. Pre-transplant average daily insulin requirement >1 IU/kg/day. Pre-transplant (the more recent value obtained within the 4 months prior to enrolment) HbA1c >11%. Patients with inadequate renal reserve as per calculated creatinine clearance (CLcr) < 60 mL/min according to the Cockcroft-Gault formula (1976). Patients with hepatic dysfunction as defined by increased ALT (alanine aminotranferase) / AST (aspartate aminotransferase) > 3 x upper limit of normal (ULN) and increased total bilirubin > 3mg/dL [>51.3 µmol/L]). Patients who receive treatment for a medical condition requiring chronic use of systemic steroids. Treatment with any anti-diabetic medication other than insulin within 4 weeks of transplant. Use of any investigational agent within 12 weeks of enrolment, including "anti-inflammatory" strategies (e.g. anti-TNFα, anti-IL-1 RA). Hypersensitivity to: ibuprofen or to more than one non steroidal anti-inflammatory drug (NSAID). medications belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib. Pregnant or breast-feeding women; unwillingness to use effective contraceptive measures (females and males). Additional exclusion criteria specific for US centre.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
50% de chances d'être dans le groupe placebo en aveugle
Groupes de traitement
Groupe I
ExpérimentalGroupe II
PlaceboObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 9 sites
The University of Chicago Medical Center, Department of Surgery, Division of Abdominal Organ Transplantation
Chicago, United StatesOuvrir The University of Chicago Medical Center, Department of Surgery, Division of Abdominal Organ Transplantation dans Google MapsInstitute for Clinical and Experimental Medicine (IKEM), Diabetes Centre; Department of Diabetes.
Prague, CzechiaDipartimento di Medicina Interna e Specialistica; IRCCS Ospedale San Raffaele
Milan, ItalyS.S.D. Diabetologia, Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Piazza Ospedale Maggiore 3
Milan, Italy