Study on Delayed Graft Function Using Paired Kidneys (NCT01561599) | Clinical Trial Compass
UnknownPhase 2
Study on Delayed Graft Function Using Paired Kidneys
Netherlands, Spain, United Kingdom12 participantsStarted 2011-08
Plain-language summary
The study is designed to evaluate the safety and efficacy of an intravenously administered drug in recipients of kidneys from cardiac death donors who are risk for developing delayed graft function.
Who can participate
Age range
18 Years – 75 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
. Subjects must sign the informed consent document prior to performance of any study related procedure including the Screening procedure.
. Males and females ≥ 18 years of age.
. Had renal transplantation due to end stage disease requiring chronic dialysis.
. Study drug can be administered within 6 to 36 hours after transplantation.
. Received kidney from donor after cardiac death.
. DCD kidney fulfills the clinical site's criteria for transplantation.
. Creatinine clearance from the transplanted kidney over a 2-hour collection period is \<10 mL/min, OR no urine output OR average urine output of \< 50 cc/H over 8 or more consecutive hours,, OR normal urine output following transplantation that diminished to average of \< 50 cc/H over 8 or more consecutive hours, OR Creatinine reduction ratio 24 hours after transplantation to pre-transplantation is \< 30%.
. Dry weight ≤ 100 kg.
Exclusion criteria
. Mean arterial pressure \<40 mmHg or cardiac index \<1.8 L/min/m2.
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.
. Recipient of multiple organ transplantation or scheduled for multiple organ transplantation.
. Recipient of kidney from a pediatric donor age 10 years or less.
. Recipient age \> 75 years.
. Patients with ASA 4 or 5
. Patients with chronic obstructive pulmonary disease (COPD) GOLD IV
. Has measurable donor-specific antibody or positive cross-match requiring deviation from standard immunosuppressive therapy.
. Currently participating in or has participated in an investigational drug or medical device study within 30 days or five half-lives, whichever is longer, prior to enrolment into this study.