Clinical trial NCT00717678: A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Kidney Transplant Recipients
Official title: A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (Tacrolimus)/MMF and Extended Release (XL) Tacrolimus /MMF in de Novo Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Transplantation Immunology
Host vs Graft Reaction
Keywords: Immunosuppressant
Combination drug therapy
Graft loss
Randomized controlled trial
Open level method
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Taiwan, Inc.
First posted: 2008-07-17
Enrollment: 73
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF in de novo kidney transplant recipients.


Eligibility criteria: Inclusion Criteria:

* Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
* Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living kidney transplant
* Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure
* 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 or is receiving an organ transplant other than a kidney
* Patient has received a kidney transplant from a non-heart beating donor
* Patient has received an ABO incompatible donor kidney
* Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
* Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
* Patient has significant liver disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
* Patient has an uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives
* Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
* Patient is receiving everolimus or enteric coated mycophenolic acid at any time during the study
* Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil or corticosteroids
* Patient is pregnant or lactating
* Patient is unlikely to comply with the visits scheduled in the protocol
* Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator

Primary outcomes:
measure: The patient and graft survival rates at 6 month post-transplant
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy failure at 6-month posttransplant.
timeFrame: 6 months
measure: Incidence of biopsy confirmed acute rejection (Banff > 1) at 6 months and 12 months
timeFrame: 6 months and 12 months
measure: 1 year patient and graft survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References: