TerminatedPhase 4

ATG Versus Basiliximab in Kidney Transplant Displaying Low Immunological Risk But High Susceptibility to DGF

Stopped: recruitment issues

France19 participantsStarted 2014-06

Plain-language summary

The primary objective of the following randomized open label trial is to demonstrate how low immunological risk patients (no anti HLA immunization and first kidney transplantation) but diagnosed at high-risk of delayed graft function (assessed by DGFS score) could benefit from induction with ATG for preventing delayed graft function compared to Basiliximab.

Who can participate

Age range

18 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: * Adults * First kidney transplantation * No anti HLA immunization prior transplantation * A risk of DGF higher than 40% calculated by the score DGFS (DGFS \>= 0.4) * Written informed consent Exclusion Criteria: * Previous or combined other transplantations * Non heart beating donors * Living donors * Pre-emptive transplantation * Patients on peritoneal dialysis * Leucopenia lower than 3000/mm3 * Thrombopenia lower than 100 000/mm3 * Donor EBV positive / recipient EBV Negative * Pregnant or lactating women * Patients under guardianship * Previous and current history of cancer and/or lymphoma * Current history of HCV or HBV or HIV infection

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

Occurrence of a delayed graft function

Timeframe: 7 days

Trial details

NCT IDNCT02056938

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-02

View on ClinicalTrials.gov More Kidney Transplantation trials