Ischaemia reperfusion injury and allograft pancreatitis. MedDRA version: 20.1 Level: PT Classification code 10066127 Term: Ischaemic pancreatitis System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: XELJANZ® (tofacitinib citrate)
Product Name: XELJANZ® (tofacitinib citrate)
Product Code: CP 690,550
Pharmaceutical Form: Tablet
Sponsors
Clinical Trials and Research Governance
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Participant is willing and able to give informed consent for participation in the trial. • Male or Female, aged 18 years to 65 years. • Participant is deemed surgically fit to proceed with combined solid organ pancreas kidney transplant • In the Investigator’s opinion, is able and willing to comply with all trial requirements. • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial. • Willing to undertake effective contraception for the duration of the trial. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. • Bladder drained pancreas transplants will be excluded • Participant with life expectancy of less than 6 months • Patients with Hepatitis B/C and HIV will be excluded • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. • Known allergy to Tofacitinib • Does not speaks or understands English • Use of contraindicated medication to Tofacitinib as per the appendix of inhibitors and inducers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and anti-inflammatory effect of Tofacitinib on allograft pancreatitis and ischaemia reperfusion, by measuring inflammatory markers in whole blood and assessing CT imaging using an oral dose of Tofacitinib 10mg BD for 7 days ; Secondary Objective: To quantify the level of inflammation observed following reperfusion of organs and identify what inflammatory pathways are being affected. To assess any association of post-operative complications with administration of the drug. Clinical parameters which affect patient experience and morbidity will also be measured ; Primary end point(s): Whole blood will be tested for the inflammatory marker C- reactive protein (CRP). CRP has been shown to be a positive surrogate marker for allograft pancreatitis and is the sole primary outcome for the study CT scan imaging - Timepoint: Day 5 post operatively, will be analysed to measure the amount of inflammation of the pancreas. ; Timepoint(s) of evaluation of this end point: Patients will have 14 blood samples taken at regular intervals following reperfusion of the pancreas. 5ml (one teaspoon) blood samples will be taken during reperfusion of the organ at times 0, 0.5, 1, 2, 4, 6, 12 and 24 hours, then once daily for the first 7 days post-surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To quantify the level of inflammation observed following reperfusion of organs and identify what inflammatory pathways are being affected. To assess the association of post operative complications and administration of the drug. ; Timepoint(s) of evaluation of this end point: Whole blood samples taken during reperfusion of the organ at 0, 0.5, 1, 2, 4, 6, 12 and 24 hours, then once daily for the first 7 days post-surgery, will be additionally tested for full cytokine analysis and cell free circulating DNA. Patients following transplantation will have all imaging within the first 7 days post-surgery examined to assess the level of allograft inflammation. Length of hospital stay, number and type of further surgery needed, results of oral glucose tolerance testing and 30 day graft survival will also be measured. | — |
Countries
United Kingdom
Contacts
Public ContactSham Dholakia
University of Oxford
Outcome results
None listed