Overview

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)