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

Yonsei University

Status and phase

Completed

Phase 4

Conditions

Kidney Transplant Patients

Treatments

Drug: B) CONTROL

Drug: A) TEST

Study type

Interventional

Funder types

Other

Identifiers

NCT01680952

4-2011-0920

Details and patient eligibility

About

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.

Enrollment

158 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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)