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OpenTrials
Completed

NCT Number: NCT01680952

Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kyungpook national hospital, Daegu, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients aged over 20 years
  • Patient who is judged would have the benefits of the Extended Release Tacrolimus (Advagraf®)treatment by the investigator
  • Patients has given written informed consent
  • Patient is a recipient of primary or recipient of primary (a living kidney transplant, a cadaveric donor.)
  • Patients has received an ABO compatible donor kidney.
  • Complement-dependent Cytotoxic Crossmatch: CDC) result: negative
  • Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization

Exclusion criteria

  • Patient has previously received an organ transplant other than a kidney.
  • Patient has a known hypersensitivity to tacrolimus, Sirolimus (Rapamune®),Mycophenolate mofetil.
  • Desensitization
  • HLA-identical
  • Heart Disease; Heart failure (symptom, EF <45%)
  • Lung Disease; Significant chronic obstructive pulmonary disease, restrictive lung disease
  • Patient has an uncontrolled concomitant infection (including Hepatitis B, Hepatitis C) or any other unstable
  • malignant tumor history in the 5years prior to enrollment. (except,squamous cell carcinoma)
  • Patient has received a kidney transplant from non-heart beating donor
  • Cold ischemic time > 30hrs
  • Elevated AST and/or ALT levels greater than 3 times the upper value of the normal range of the investigational site
  • (ANC)<1,500/mm3, (WBC)<2,500/ mm3, (PLT)<100,000/ mm3
  • ATG: Anti-thymocyte globulin induction
  • Medical condition that could interfere with the study objectives.
  • Patient is currently taking or has been taking an investigational products in the 30 days prior to enrollment.
  • Patient is currently taking or has been taking an prohibited medications in the 28 days prior to enrollment.
  • Patient who is judged not to be adequate by the investigator owing to other reasons
  • Patient is pregnant or lactating.
  • Recipient or donor is known to be seropositive for human immunodeficiency virus.(HIV)

Treatment and study plan

A) TEST

Drug
  • 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.

  • Sirolimus (Rapamune®):

After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level.

Other names: 1. Test group : Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®)

B) CONTROL

Drug
  • Extended Release Tacrolimus (Advagraf®)

: Same as above.

  • Mycophenolate mofetil : After surgery : 500mg/kg po. within 24hrs after reperfusion. After that, daily dose: 1000mg bid

Other names: 2. Control group: Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil

Primary outcomes

  1. Failure rate in effectiveness of up to 12 months after kidney transplant

    Time frame: 12 months after kidney transplant

    • Biopsy confirmed acute rejection
    • Subjects and graft survival
    • Glomerular filtration rate (GFR)
    • 24-hour urine test results at 12 months after kidney transplant: Urine protein, CrCl.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 7, 2012
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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