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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00064701
First received: July 10, 2003
Last updated: November 10, 2011
Last verified: November 2011
History of Changes
  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 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 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:

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:
Cyclosporins
Cyclosporine
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013