A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Kidney Transplant Recipients

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation; Transplantation Immunology; Host vs Graft Reaction
• Intervention / Treatment: Drug: Prograf-XL; Drug: MMF; Drug: Prograf

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 407
  • Tainan, Taiwan, 704
  • Taipei, Taiwan, 100
  • Taipei, Taiwan, 112
  • Taoyuan, Taiwan, 333

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prograf-XL + MMF	Drug: Prograf-XL; oral; Other Names: tacrolimus extended release; MR4; FK506XL; Drug: MMF; oral; Other Names: Mycophenolate Mofetil
Active Comparator: Prograf + MMF	Drug: MMF; oral; Other Names: Mycophenolate Mofetil; Drug: Prograf; oral; Other Names: FK506; tacrolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The patient and graft survival rates at 6 month post-transplant	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Efficacy failure at 6-month posttransplant.	6 months
Incidence of biopsy confirmed acute rejection (Banff > 1) at 6 months and 12 months	6 months and 12 months
1 year patient and graft survival	1 year

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: Astellas Pharma Taiwan, Inc.

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results Web site

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: July 16, 2008
• First Submitted That Met QC Criteria: July 16, 2008
• First Posted (Estimate): July 17, 2008

Study Record Updates

• Last Update Posted (Estimate): December 17, 2015
• Last Update Submitted That Met QC Criteria: December 16, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Combination drug therapy; Immunosuppressant; Graft loss; Open level method
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Calcineurin Inhibitors; Tacrolimus; Mycophenolic Acid
• Other Study ID Numbers: PRGXLKTx-0701-TW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED