Study to Evaluate the Combination of Enteric-coated Mycophenolate Sodium (EC-MPS), Basiliximab, a… (NCT00154232) | Clinical Trial Compass
CompletedPhase 4
Study to Evaluate the Combination of Enteric-coated Mycophenolate Sodium (EC-MPS), Basiliximab, and C2-monitored Cyclosporine in de Novo Renal Transplant Recipients at Potential High Risk of Delayed Graft Function (DGF)
46 participantsStarted 2004-06
Plain-language summary
The aim of the study is to assess the short-term benefit of the combination of basiliximab, EC-MPS and cyclosporine microemulsion with C2 monitoring on the prophylaxis of acute rejection in a population of de novo renal transplant patients at potential high risk of DGF.
Who can participate
Age range
18 Years – 70 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 18-70 years old
* Patients receiving a primary or secondary cadaveric or living donor kidney
* Patients who have given written informed consent for study participation
* Females capable of becoming pregnant must have a negative pregnancy test at baseline and are required to practice birth control for the duration of the study and at least for four months following the last dose of basiliximab.
Exclusion Criteria:
* Recipient of multi-organ transplants or previously transplanted organs other than kidney
* Recipient of dual kidney transplants
* Recipient of a transplanted kidney from a Non-Heart Beating Donor (NHBD)
* Recipient of a HLA identical living-donor kidney
* Patients with a PRA level (past or current level) greater than 20%
* Patients anticipated by investigators to require induction therapy with OKT3, ATGAM, or Thymoglobulin for any reason
* Patients with any medical condition which, in the opinion of the investigator, would preclude the patient from participating in the study
* Cold ischemia time larger than 36 hours.
* Patients who have received an investigational drug or therapy within one month prior to study entry or if such therapy is to be instituted post-transplantation.
* Female transplant candidates who are pregnant, lactating, or of childbearing potential and not willing to practice an acceptable method of contraception
* Patients with a known hypersensitivity to cyclosporine
* Patients with a known malignancy or a history of…
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
1
Incidence of first episodes of BPAR at month 3 post transplant