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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Loma Linda, California, United States, 92354
Los Angeles, California, United States, 90057
United States, Colorado
Denver, Colorado, United States, 80262
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
New Orleans, Louisiana, United States, 70121
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston, Massachusetts, United States, 02111
United States, Michigan
Detroit, Michigan, United States, 48202
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
Rochester, Minnesota, United States, 55905
United States, Nebraska
Omaha, Nebraska, United States, 68198
United States, New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
Buffalo, New York, United States, 14203
New York, New York, United States, 10021
New York, New York, United States, 10029
United States, Ohio
Cincinnati, Ohio, United States, 45267
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Providence, Rhode Island, United States, 02903
United States, Tennessee
Memphis, Tennessee, United States, 38163
Nashville, Tennessee, United States, 37232
United States, Texas
Galveston, Texas, United States, 77555
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake City, Utah, United States, 84103
Salt Lake City, Utah, United States, 84132
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: central contact Astellas Pharma US, Inc.
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sr. Manager Clinical Trail Registry, Astellas Pharma US, Inc
ClinicalTrials.gov Identifier: NCT00650468    
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:
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Mycophenolic Acid
Prednisone
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