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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00717678
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : December 17, 2015
Astellas Pharma Taiwan, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Transplantation Immunology Host vs Graft Reaction Drug: Prograf-XL Drug: Prograf Drug: MMF Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Prograf-XL + MMF Drug: Prograf-XL
Other Names:
  • tacrolimus extended release
  • FK506XL
  • MR4
Drug: MMF
Other Name: Mycophenolate Mofetil
Active Comparator: Prograf + MMF Drug: Prograf
Other Names:
  • tacrolimus
  • FK506
Drug: MMF
Other Name: Mycophenolate Mofetil

Primary Outcome Measures :
  1. The patient and graft survival rates at 6 month post-transplant [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Efficacy failure at 6-month posttransplant. [ Time Frame: 6 months ]
  2. Incidence of biopsy confirmed acute rejection (Banff > 1) at 6 months and 12 months [ Time Frame: 6 months and 12 months ]
  3. 1 year patient and graft survival [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00717678

Taichung, Taiwan, 407
Tainan, Taiwan, 704
Taipei, Taiwan, 100
Taipei, Taiwan, 112
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Taiwan, Inc.
Study Chair: Central Contact Astellas Pharma Inc

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00717678     History of Changes
Other Study ID Numbers: PRGXLKTx-0701-TW
First Posted: July 17, 2008    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
Combination drug therapy
Graft loss
Randomized controlled trial
Open level method

Additional relevant MeSH terms:
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents