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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

Phase 4
Completed
Conditions
Kidney Transplant Patients
Interventions
Drug: A) TEST
Drug: B) CONTROL
Registration Number
NCT01680952
Lead Sponsor
Yonsei University
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
158
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
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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)
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
A) TESTA) TEST-
A) TESTB) CONTROL-
B) CONTROLA) TEST-
B) CONTROLB) CONTROL-
Primary Outcome Measures
NameTimeMethod
Failure rate in effectiveness of up to 12 months after kidney transplant12 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (7)

Gangnam Severance hospital

🇰🇷

Seoul, Korea, Republic of

Korea University Anam Hospital

🇰🇷

Seoul, Korea, Republic of

Seoul National University hospital

🇰🇷

Seoul, Korea, Republic of

Kyungpook national hospital

🇰🇷

Daegu, Korea, Republic of

Severance hospital

🇰🇷

Seoul, Korea, Republic of

Ulsan Univ Hospital

🇰🇷

Ulsan, Korea, Republic of

Ajou Univeristy Medical Center

🇰🇷

Suwon, KyungKi Province, Korea, Republic of

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