CompletedPhase 3

Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk

France227 participantsStarted 2001-05

Plain-language summary

To compare renal allograft rejection rates during the first year among high-immunological risk recipients between patients who received either ATG or the anti-IL2R mAb daclizumab.

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

. Third or fourth renal graft or
. Current anti-HLA antibodies above or equal to 30% at the last evaluation or
. Peak anti-HLA antibodies above or equal to 50% at the last evaluation or
. A second graft if the first was lost within 2 years because of rejection.
. Patients who gave their informed consent and are able to understand the scope of the study

Exclusion criteria

. Transplantation from living donors or recipients of multiple grafts or patients who already have received another (non-renal) allograft.
. Transplantation from a non-heart beating donor
. Transplantation of two kidneys from the same donor
. Patients with generalized infection at the time of transplantation
. Women in child-bearing age who do not plan to use efficient contraception

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

Incidence of biopsy-proven acute allograft rejection during the first post-transplant year

Timeframe: acute rejection proved by graft biopsy

Trial details

NCT IDNCT00682292

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-11

View on ClinicalTrials.gov More Renal Transplantation trials