Effects of the Use of "de Novo" Everolimus in Renal Tranplant Population (NCT01663805) | Clinical Trial Compass
UnknownPhase 4
Effects of the Use of "de Novo" Everolimus in Renal Tranplant Population
Brazil80 participantsStarted 2012-01
Plain-language summary
This is an open, randomized, single-center study. The selected patients will be first divided into two major groups according to the type of organ to be transplanted: standard criteria donor (SCD) or extended criteria (ECD) kidney. Then, each group will be randomly allocated to one of the treatments: tacrolimus (TAC) or everolimus (EVL).
All patients received induction therapy with basiliximab (BXB) and maintenance with Mycophenolate Sodium (MYF) and prednisone (P). This study will evaluate as Primary objectives: To characterize the molecular profile of cytokines in kidneys obtained from deceased donors such as "standard" (SCD) and extended criteria (ECD) in biopsies taken before and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in the expression of these molecules. And as Secondaries objectives: To correlate the pattern of cytokines with delayed graft function (DGF), cold ischemia time, episodes of acute rejection and patient and graft survival.
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:
* Age ≥ 18 years (black and white subjects);
* End-stage renal disease with indication for transplantation (primary deceased-donor kidney transplant)
* "Standard" traditional (SCD) or extended criteria (ECD) donor;
* Informed consent form duly signed before SCD or ECD kidney transplantation.
Exclusion criteria:
* The subject, in the opinion of the investigator, is not able to complete the study protocol;
* Recipient of live-donor kidney graft;
* Multiple organ transplant recipient;
* Evidence of large systemic or localized infection;
* Evidence of infiltration, cavitation or consolidation on chest X-rays obtained during the evaluation in the screening / baseline visit;
* Use of any drug under investigation or treatment until up to 4 weeks before transplantation;
* Known or suspected hypersensitivity to tacrolimus, everolimus or mycophenolate sodium;
* Immunosuppressive therapies in addition to those described for this study;
* Hypersensitized patients (PRA \> 30%);
* Patients with HIV+ or Hepatitis B or C virus infection.
* Patients for whom T0 and T15 biopsies were not taken.
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.