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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00650468 |
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 IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
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 |
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 |
---|---|
1: Experimental
early steroid cessation
|
Drug: tacrolimus
Oral
Drug: CellCept
IV or Oral
Drug: steroids (methylprednisone or prednisone)
IV or Oral
|
2: Experimental
long-term maintenance steroids
|
Drug: tacrolimus
Oral
Drug: CellCept
IV or Oral
Drug: steroids (methylprednisone or prednisone)
IV or Oral
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Study Director: | central contact | Astellas Pharma US, Inc. |
Responsible Party: | Astellas Pharma US, Inc ( Sr. Manager Clinical Trail Registry ) |
Study ID Numbers: | 20-99-001 |
Study First Received: | March 17, 2008 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00650468 History of Changes |
Health Authority: | United States: Institutional Review Board |
Renal Transplantation Prograf |
Anti-Inflammatory Agents Prednisone Immunologic Factors Antineoplastic Agents, Hormonal Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
Mycophenolate mofetil Tacrolimus Immunosuppressive Agents Hormones Glucocorticoids |
Anti-Inflammatory Agents Prednisone Immunologic Factors Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Tacrolimus Glucocorticoids Hormones Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Mycophenolate mofetil |