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

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ClinicalTrials.gov Identifier: NCT00650468
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : November 17, 2011
Sponsor:
Information provided by:
Astellas Pharma Inc

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 397 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 1999
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Assessment of death, graft loss, or severe acute rejection [ Time Frame: 6 months, 12 months, yearly up to 5 years ]

Secondary Outcome Measures :
  1. Comparison of patient and graf survival [ Time Frame: 6 months, 12 months, yearly up to 5 years ]
  2. Incidence and severity of acute rejection [ Time Frame: 6 months, 12 months, yearly up to 5 years ]
  3. Need for antilymphocyte treatment [ Time Frame: 6 months, 12 months, yearly up to 5 years ]
  4. Graft function [ Time Frame: 6 month, 12 months, yearly up to 5 years ]
  5. Framingham Coronary Heart Disease Risk Factors [ Time Frame: 6 months, 12 months, yearly up to 5 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00650468


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

Publications:
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
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: November 17, 2011
Last Verified: March 2009

Keywords provided by Astellas Pharma Inc:
Renal Transplantation
Prograf

Additional relevant MeSH terms:
Prednisone
Mycophenolic Acid
Tacrolimus
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents