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Sponsored by: |
University of Pennsylvania |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00596947 |
The purpose of the study is to determine if rapid discontinuation of corticosteroids and maintenance immunosuppression with Prograf (Tacrolimus) and CellCept (Mycophenolate mofetil) will give similar safety and efficacy results compared to standard maintenance with Prograf, CellCept and corticosteroids (triple therapy) while using Thymoglobulin (another immunosuppressive medication used to prevent acute rejection at the time of transplantation) in patients.
Condition | Intervention | Phase |
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Kidney Transplantation |
Drug: Corticosteroid withdrawal Drug: Continuation of prednisone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Prospective Single-center Study Comparing a Rapid Discontinuation of Corticosteroids (Steroid Withdrawal) With Corticosteroid Therapy in Kidney Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy |
Enrollment: | 19 |
Study Start Date: | October 2005 |
Study Completion Date: | March 2009 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Experimental
If you are randomized to Group 1, you will start on 3 drugs; Prograf, CellCept and corticosteroids. However, your dose of corticosteroids will rapidly be decreased until completely eliminated by day 6 after transplant
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Drug: Corticosteroid withdrawal
If you are randomized to Group 1, you will start on 3 drugs; Prograf, CellCept and corticosteroids. However,your dose of corticosteroids will rapidly be decreased until complete elimination by day 6 after transplant |
Group 2: No Intervention
If you are randomized to Group 2, you will start on 3 drugs; Prograf, CellCept and corticosteroids. You will remain on all three drugs according to your doctors' standard of care and the corticosteroids will not be eliminated.
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Drug: Continuation of prednisone
If you are randomized to Group 2, you will start on 3 drugs; Prograf, CellCept and corticosteroids. You will remain on all three drugs according to your doctors' standard of care and the corticosteroids will not be eliminated.
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Corticosteroids have been used in clinical transplantation for more than 30 years. There are many side effects of corticosteroids including significant bone disease, diabetes (elevated blood sugar levels), fluid retention and hypertension (high blood pressure), psychosis, peptic ulcer disease, hyperlipidemia (elevated lipid levels such as cholesterol and triglycerides), obesity (overweight), acne, and susceptibility to infections. It is hoped that the new generation of potent immunosuppressive medications (such as Prograf and CellCept) will permit avoidance or withdrawal of corticosteroids for the majority of patients to avoid both short- and long-term complications of corticosteroid use in kidney transplant recipients.
You will start receiving antirejection medications (thymoglobulin and steroids) while you are in the operating room before the transplant surgical procedure is completed and the rest of the doses will be given while you are on the transplant floor (Thymoglobulin is given as an intravenous infusion for a total of 3-5 doses). Regardless of which treatment group you are randomized to, you will start taking your oral (by mouth) antirejection treatment within 24 hours of the transplant. All patients will be started on three (3) oral antirejection medications:
Ages Eligible for Study: | 19 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Hospital of the University od Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Simin Goral, MD | University of Pennsylvania-Renal Electrolyte and Hypertension Division |
Responsible Party: | Hospital of the University of Pennsylvania ( Simin Goral ) |
Study ID Numbers: | 803242 |
Study First Received: | January 8, 2008 |
Last Updated: | July 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00596947 History of Changes |
Health Authority: | United States: Institutional Review Board |
kidney transplantation tacrolimus mycophenolate mofetil corticosteroid withdrawal rabbit antithymocyte globulin |
Antilymphocyte Serum Anti-Bacterial Agents Prednisone Immunologic Factors |
Mycophenolic Acid Mycophenolate mofetil Tacrolimus Immunosuppressive Agents |
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Mycophenolic Acid |
Mycophenolate mofetil Enzyme Inhibitors Tacrolimus Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |