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 range20 Years – 65 Years
SexALL
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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…
What they're measuring
1
Incidence of efficacy failure (treated-BCAR, biopsy-confirmed acute rejection, graft loss rate, death, or follow-up failure)