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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Taiwan, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00717678
First received: July 16, 2008
Last updated: June 10, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Kidney Transplantation
Transplantation Immunology
Host vs Graft Reaction
Drug: Prograf-XL
Drug: Prograf
Drug: MMF
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • The patient and graft survival rates at 6 month post-transplant [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy failure at 6-month posttransplant. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of biopsy confirmed acute rejection (Banff > 1) at 6 months and 12 months [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • 1 year patient and graft survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: December 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prograf-XL + MMF Drug: Prograf-XL
oral
Other Names:
  • tacrolimus extended release
  • FK506XL
  • MR4
Drug: MMF
oral
Other Name: Mycophenolate Mofetil
Active Comparator: Prograf + MMF Drug: Prograf
oral
Other Names:
  • tacrolimus
  • FK506
Drug: MMF
oral
Other Name: Mycophenolate Mofetil

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717678

Locations
Taiwan
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.
Investigators
Study Chair: Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00717678     History of Changes
Other Study ID Numbers: PRGXLKTx-0701-TW
Study First Received: July 16, 2008
Last Updated: June 10, 2010
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Mycophenolate mofetil
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014