Comparative Study of Modified Release (MR) Tacrolimus/MMF in de Novo Kidney Transplant Recipients - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by (Responsible Party):	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00064701

Purpose

The purpose of this study is to compare the safety and efficacy of Prograf/MMF, Neoral/MMF and Modified Release (MR) Tacrolimus/MMF in de novo kidney transplant recipients.

Condition	Intervention	Phase
Kidney Transplantation	Drug: Tacrolimus Modified Release (MR) Drug: Tacrolimus Drug: cyclosporine microemulsion Drug: mycophenolate mofetil	Phase III

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 Phase III, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (Tacrolimus)/MMF, Modified Release (MR) Tacrolimus/MMF and Neoral (Cyclosporine)/MMF in de Novo Kidney Transplant Recipients

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Cyclosporine Cyclosporin Tacrolimus anhydrous Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

1 yr Efficacy Failure (composite endpoint defined as death, graft loss, having biopsy confirmed acute rejection or lost-to follow up) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

1 year patient and graft survival rates [ Time Frame: Annually and End of Study ] [ Designated as safety issue: No ]
Incidence of biopsy confirmed acute rejection (Banff Grade ≥ 1) at 6 and 12 months, time to first acute rejection episode, [ Time Frame: Annually and End of Study ] [ Designated as safety issue: No ]
Requirement of anti-lymphocyte antibody therapy for treatment of rejection [ Time Frame: Annually and End of Study ] [ Designated as safety issue: No ]
Severity of acute rejection [ Time Frame: Annually and End of Study ] [ Designated as safety issue: No ]
Number of patients experiencing multiple rejection episodes [ Time Frame: Annually and End of Study ] [ Designated as safety issue: No ]
Number of clinically treated acute rejection episodes [ Time Frame: Annually and End of Study ] [ Designated as safety issue: No ]
Incidence of crossover for treatment failure,Evaluation of renal function. [ Time Frame: Annually and End of Study ] [ Designated as safety issue: No ]

Enrollment:	668
Study Start Date:	June 2003
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Tacrolimus Modified Release (MR) Oral Other Name: Advagraf, FK506E-MR, FKMR, MR4 Drug: mycophenolate mofetil Oral Other Name: CellCept, MMF
Active Comparator: 2 tacrolimus	Drug: Tacrolimus Oral Other Name: Prograf, FK506 Drug: mycophenolate mofetil Oral Other Name: CellCept, MMF
Active Comparator: 3 CsA	Drug: cyclosporine microemulsion Oral Other Name: Neoral, CsA Drug: mycophenolate mofetil Oral Other Name: CellCept, MMF

Detailed Description:

This will be a 3 arm randomized, open-label, comparative, multi-center study in de novo kidney transplant recipients. Enrollment will include approximately 660 patients at 60-70 centers in the U.S., Canada and South America.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Recipient of a primary or retransplanted non-HLA-identical living or non-HLA-identical cadaveric kidney transplant
Age greater or equal to 12 years

Exclusion Criteria:

Recipient or donor is known seropositive for human immunodeficiency virus (HIV)
Has current malignancy or history of malignancy
Has significant liver disease
Has uncontrolled concomitant infection or any other unstable medical condition
Is receiving everolimus or enteric coated mycophenolic acid at any time during the study
Received kidney with a cold ischemia time of equal or more than 36 hours
Received kidney transplant from a cadaveric donor equal or more than 60 years of age
Received IVIG therapy prior to randomization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064701

Show 57 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use Central Contact

Astellas Pharma Global Development

More Information

No publications provided

Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00064701 History of Changes
Other Study ID Numbers:	02-0-158
Study First Received:	July 10, 2003
Last Updated:	November 10, 2011
Health Authority:	United States: Food and Drug Administration; Brazil: Ministry of Health; Canada: Health Canada

Keywords provided by Astellas Pharma Inc:

De Novo Kidney Transplant
cyclosporine
Prograf®
mycophenolate mofetil
tacrolimus

Additional relevant MeSH terms:

Cyclosporine
Cyclosporins
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

Dermatologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012