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

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

MedlinePlus related topics:

Kidney Transplantation

Drug Information available for:

Tacrolimus Cyclosporin Cyclosporine Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Tacrolimus Modified Release (MR) Oral Drug: mycophenolate mofetil Oral
2: Active Comparator tacrolimus	Drug: Tacrolimus Oral Drug: mycophenolate mofetil Oral
3: Active Comparator CsA	Drug: cyclosporine microemulsion Oral Drug: mycophenolate mofetil Oral

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 52 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators


Study Director:	Use Central Contact	Astellas Pharma US, Inc.

More Information

Responsible Party:	Astellas Pharma US, Inc ( Sr Manager Clinical Trial Registries )
Study ID Numbers:	02-0-158
First Received:	July 10, 2003
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00064701
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

De Novo Kidney Transplant

cyclosporine

Prograf®

mycophenolate mofetil

tacrolimus

Study placed in the following topic categories:

Cyclosporine

Clotrimazole

Miconazole

Tioconazole

Mycophenolic Acid

Mycophenolate mofetil

Tacrolimus

Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Antibiotics, Antineoplastic

Immunosuppressive Agents

Pharmacologic Actions

Antifungal Agents

Therapeutic Uses

Antirheumatic Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00064701