Reparixin in Prevention of Delayed Graft Function After Kidney Transplantation (NCT00248040) | Clinical Trial Compass
CompletedPhase 2
Reparixin in Prevention of Delayed Graft Function After Kidney Transplantation
United States, France, Italy80 participantsStarted 2005-10
Plain-language summary
The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after solid organ transplantation. Reparixin is a novel, specific inhibitor of CXCL8. This study is configured to explore the safety and efficacy of reparixin in preventing the delayed graft function (DGF) after kidney transplantation.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female patients accepted and listed for renal transplantation due to end stage renal disease (ESRD)
* Planned isolated single kidney transplant from a non-living donor with brain death
* Recipients of a kidney maintained in cold storage
* Recipients at risk of developing DGF
* Planned induction with steroids + mycophenolate mofetil (MMF) or mycophenolic acid + biological induction
* Patient willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations
* Patient 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care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 an intended multiple organ transplant
* Recipients of a kidney from a living donor
* Recipients of a kidney from a non-heart beating donor
* Recipients of double kidney transplant
* Re-transplant \>2
* Recipients of a kidney maintained by pulsatile machine perfusion
* Concurrent sepsis
* Recipients with hepatic dysfunction at the time of transplant
* Clinical contraindications to central line access, or arteriovenous fistula, if any, not suitable for infusion of investigational product
* Hypersensitivity to non steroidal anti-inflammatory drugs (NSAIDs)
* Patients simultaneously participating in any other clinical trials involving an investigationa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Creatinine Clearance (CrCl) in the Immediate Post-transplant Period
Timeframe: 1-3 and 10-12 hours post allograft reperfusion