| Trial ID: | L0006 |
| Source ID: | NCT01964014
|
| Associated Drug: |
Advagrf
|
| Title: |
Once-a-day Immunosuppression(CISECON_a_day)
|
| Acronym: |
CISECON
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Renal Disease
|
| Interventions: |
DRUG: advagrf
|
| Outcome Measures: |
Primary: acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up, The primary objective of this study is to investigate the efficacy of Advagraf ® (Extended Release Tacrolimus) at 6 months after immunosuppressant conversion to the once daily therapy. The efficacy is defined as the incidence rate of composite endpoints of efficacy failure (acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up)., 6months | Secondary: renal functions, Difference in renal functions (eGFR by MDRD method), urine protein excretion and P/C ratio (A/C ratio), transplant kidney biopsy histology (if biopsy is performed)., 6months|serious adverse events, Frequency and severity of adverse events and serious adverse events, 6months|cardiovascular health, Treatment impact on cardiovascular health: blood pressure and cardiovascular events (acute myocardial infarction, unstable angina pectoris, heart failure, stroke)., 6months|NODAT, Incidence rate of new onset diabetes after transplantation (NODAT) requiring treatment., 6months|hematology issue, Frequency of anemia, leucopenia, and thrombocytopenia., 6months
|
| Sponsor/Collaborators: |
Sponsor: Ajou University School of Medicine
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
160
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-10
|
| Completion Date: |
2015-10
|
| Results First Posted: |
|
| Last Update Posted: |
2016-07-21
|
| Locations: |
Nephrology, Pusan National University Hospital, Busan, Korea, Republic of|Bundang CHA Medical Center,, Gyeonggi-do, Korea, Republic of|Inje University Ilsan Paik Hospital, Gyeonggido, Korea, Republic of|Korea University Medical Center, Seoul, Korea, Republic of|Severance Hospital, Seoul, Korea, Republic of|Soonchunhyang University Hosptial, Seoul, Korea, Republic of|Dept. of Surgery, Ulsan University Hospital, Ulsan, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01964014
|
