NCT01680952|CompletedPhase 4
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Sponsor study identifier
interventional
158
1 country
7
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil in Kidney Transplant Patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
September 4, 2012
Actual (reported)September 7, 2012
Actual (reported)January 2016
Actual (reported)January 2016
Actual (reported)Failure rate in effectiveness of up to 12 months after kidney transplant
1. Biopsy confirmed acute rejection 2. Subjects and graft survival 3. Glomerular filtration rate (GFR) 4. 24-hour urine test results at 12 months after kidney transplant: Urine protein, CrCl.
12 months after kidney transplant
1. Extended Release Tacrolimus (Advagraf®) ① Living The day before surgery: 0.2 mg/kg(morning dose) po, qd Morning on the day of surgery: 0.1 mg/kg po, qd After surgery, the capacity is adjusted according to the trough level. clinical significance, electrolyte level. ② Cadaveric Before surgery at once : 0.1 mg/kg within 12hours before surgery. After surgery : 0.2mg/kg po. in the morning After that, the capacity is adjusted according to the trough level. clinical significance, electrolyte level. 2. Sirolimus (Rapamune®): After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level.
Kyungpook national hospital
Daegu, Daegu, South Korea
Ajou Univeristy Medical Center
Suwon, KyungKi Province, South Korea
Severance hospital
Seoul, Seoul, 120-752, South Korea
Gangnam Severance hospital
Seoul, Seoul, South Korea
Korea University Anam Hospital
Seoul, Seoul, South Korea
Seoul National University hospital
Seoul, Seoul, South Korea
Ulsan Univ Hospital
Ulsan, Ulsan, South Korea
Huh KH, Lee JG, Ha J, Oh CK, Ju MK, Kim CD, Cho HR, Jung CW, Lim BJ, Kim YS; RECORD Study. De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: a multicentre, open-label, randomized, controlled, non-inferiority trial. Nephrol Dial Transplant. 2017 Aug 1;32(8):1415-1424. doi: 10.1093/ndt/gfx093.
158 participants (actual enrollment reported by the registry).
First Submitted
September 4, 2012
First Posted
September 7, 2012
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
1. Extended Release Tacrolimus (Advagraf®) : Same as above. 2. Mycophenolate mofetil : After surgery : 500mg/kg po. within 24hrs after reperfusion. After that, daily dose: 1000mg bid
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)Last Updated
March 8, 2016
Record last verified: 2016-03
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Source: ClinicalTrials.gov.
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