Study to Evaluate the Safety and Efficacy of Advagraf vs Prograf in Kidney Transplantation Patien… (NCT01742624) | Clinical Trial Compass
CompletedPhase 4
Study to Evaluate the Safety and Efficacy of Advagraf vs Prograf in Kidney Transplantation Patients 1 Month After the Transplantation
South Korea60 participantsStarted 2012-04
Plain-language summary
To investigate the efficacy, safety, and drug compliance of Advagraf® (Extended Release Tacrolimus) by comparing the Advagraf® + steroid + Mycophenolate Mofetil combined therapy and the Prograf® + steroid + Mycophenolate Mofetil combined therapy in de novo kidney recipients 1 month after kidney transplantation.
Who can participate
Age range
20 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:
* Patients who are planning to receive a kidney from a deceased/cadaveric donor or a living non-related/related donor
* Patients who are planning to undergo kidney transplantation through a 15- 65-year-old donor
* Patients who are willing and able to participate in this study, who signed the informed consent form after following the appropriate informed consent process, and who can visit the center based on the study schedule in the protocol.
Exclusion Criteria:
* Patients who had received a kidney or another organ and who will receive other organs with the kidney or two kidneys
* Patients who will receive a kidney from a cadaveric donor whose heart is no longer beating or from an organ donor after cardiac death \[Patients, however, who will receive a kidney from a marginal donor (based on KONOS) can be enrolled based on the principal investigator's judgment.\]
* Patients who will receive a kidney from a donor whose ABO blood type is not compatible with that of the recipient or who had positive lymphocyte cross-match (LCM) results
* Patients who will receive a kidney from a related donor who showed HLA-0 mismatch (identical) (If the donor is not related to the patient or is deceased, however, the patient can be enrolled in this study even if the patient showed HLA-0 mismatch or HLA-6 antigen match.)
* Patients who previously underwent or are planning to undergo transplantation of their extra-renal solid organ or bone marrow/stem cell
* Patients who were…
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 efficacy failure (treated-BCAR, biopsy-confirmed acute rejection, graft loss rate, death, or follow-up failure)