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

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:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Mycophenolic acid Mycophenolate sodium Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate mofetil

U.S. FDA Resources

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

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 May 19, 2013