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

Tracking Information

First Received Date ^ICMJE

July 10, 2003

Last Updated Date

May 15, 2009

Start Date ^ICMJE

June 2003

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

1 yr Efficacy Failure (composite endpoint defined as death, graft loss, having biopsy confirmed acute rejection or lost-to follow up)

Change History

Complete list of historical versions of study NCT00064701 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

1 year patient and graft survival rates
Incidence of biopsy confirmed acute rejection (Banff Grade ≥ 1) at 6 and 12 months, time to first acute rejection episode,
Requirement of anti-lymphocyte antibody therapy for treatment of rejection
Severity of acute rejection
Number of patients experiencing multiple rejection episodes
Number of clinically treated acute rejection episodes
Incidence of crossover for treatment failure,Evaluation of renal function.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Kidney Transplantation

Intervention ^ICMJE

Drug: Tacrolimus Modified Release (MR)
Drug: Tacrolimus
Drug: cyclosporine microemulsion
Drug: mycophenolate mofetil

Study Arms / Comparison Groups

Active Comparator: tacrolimus
Active Comparator: CsA

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

668

Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Brazil, Canada

Administrative Information

NCT ID ^ICMJE

NCT00064701

Responsible Party

Sr Manager Clinical Trial Registries, Astellas Pharma Global Development

Study ID Numbers ^ICMJE

02-0-158

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Use Central Contact

Astellas Pharma Global Development

Information Provided By

Astellas Pharma Inc

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP