A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00650468
First received: March 17, 2008
Last updated: November 15, 2011
Last verified: March 2009
  Purpose

A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept


Condition Intervention Phase
Renal Transplantation
Drug: tacrolimus
Drug: CellCept
Drug: steroids (methylprednisone or prednisone)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multi-Center Double-Blind Study of Early Corticosteroid Cessation vs. Long Term Corticosteroid Therapy With Prograf and CellCept in Primary Renal Transplant Patients

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Assessment of death, graft loss, or severe acute rejection [ Time Frame: 6 months, 12 months, yearly up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of patient and graf survival [ Time Frame: 6 months, 12 months, yearly up to 5 years ] [ Designated as safety issue: No ]
  • Incidence and severity of acute rejection [ Time Frame: 6 months, 12 months, yearly up to 5 years ] [ Designated as safety issue: No ]
  • Need for antilymphocyte treatment [ Time Frame: 6 months, 12 months, yearly up to 5 years ] [ Designated as safety issue: No ]
  • Graft function [ Time Frame: 6 month, 12 months, yearly up to 5 years ] [ Designated as safety issue: No ]
  • Framingham Coronary Heart Disease Risk Factors [ Time Frame: 6 months, 12 months, yearly up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 397
Study Start Date: November 1999
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
early steroid cessation
Drug: tacrolimus
Oral
Other Names:
  • Prograf
  • FK506
Drug: CellCept
IV or Oral
Other Names:
  • MMF
  • Mycophenolate mofetil
Drug: steroids (methylprednisone or prednisone)
IV or Oral
Other Names:
  • methylprednisone
  • prednisone
Experimental: 2
long-term maintenance steroids
Drug: tacrolimus
Oral
Other Names:
  • Prograf
  • FK506
Drug: CellCept
IV or Oral
Other Names:
  • MMF
  • Mycophenolate mofetil
Drug: steroids (methylprednisone or prednisone)
IV or Oral
Other Names:
  • methylprednisone
  • prednisone

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Patient is between post kidney transplant day 3-7 and no requirement for dialysis

Exclusion:

  • Patient is receiving kidney from HLA identical,living donor
  • Patient is a multi-organ transplant recipient
  • Patient is pregnant or lactating. Female patients of child bering potential must have a negative pregnancy test and agree to practice effective birth control
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650468

  Show 29 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: central contact Astellas Pharma US, Inc.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sr. Manager Clinical Trail Registry, Astellas Pharma US, Inc
ClinicalTrials.gov Identifier: NCT00650468     History of Changes
Other Study ID Numbers: 20-99-001
Study First Received: March 17, 2008
Last Updated: November 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Astellas Pharma Inc:
Renal Transplantation
Prograf

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
Prednisone
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on August 01, 2014