Efficacy and Safety of Two Anti-T-lymphocyte Immune Globulin (ATG-F) Induction Regimens in Anew K… (NCT02267512) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of Two Anti-T-lymphocyte Immune Globulin (ATG-F) Induction Regimens in Anew Kidney Transplant Patients
China280 participantsStarted 2012-07-31
Plain-language summary
To investigate the efficacy and safety of ATG-F induction regimen using a single dose of ATG-F compared with a five-day dose regimen of ATG-F in anew kidney transplant recipients.
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:
* Patient with end stage kidney disease who is a suitable candidate for primary kidney transplantation.
* Patients scheduled to undergo renal allograft transplantation with compatible ABO blood type.
* Peak PRA \<50%
* Females of childbearing potential must have a negative pregnancy test within 48hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study.
* Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained.
Exclusion Criteria:
* Subject has previously received or is receiving an organ transplant other than kidney
* Subject is receiving double-kidney transplant.
* Subject is receiving an ABO incompatible or T-cells cross match positive transplant.
* Cold ischemia time of allograft is \> 24 hours before kidney transplantation surgery.
* Subject is receiving organ from a Human Leukocyte Antibody (HLA) identical donor.
* Known contraindication to administration of ATG-F, including:
* Subject has known hypersensitivity to rabbit proteins
* Subject with severe thrombocytopenia
* Subject with bacterial, viral or mycotic infections which are not under therapeutically control
* Subject has known hypersensitivity to tacrolimus, macrolide antibiotics, mycophenolate mofetil, or any of the product excipients.
* Subject is unlikely to c…
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.