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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus; Tacrolimus

Criteria

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)