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Sponsors and Collaborators: |
University of Cincinnati Genzyme |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00771745 |
To determine how safe and effective giving Thymoglobulin before transplantation to patients who are going to be receiving kidney transplants.
Condition | Intervention | Phase |
---|---|---|
Organ Transplantation Transplantation Immunology |
Drug: anti-thymocyte globulin (rabbit) |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Single Center, Pilot Study of Pretransplant Thymoglobulin Administration and Early Corticosteroid Withdrawal in Living Donor Renal Transplant Recipients Under Mycophenolate Mofetil (MMF) and Tacrolimus Maintenence Immunosuppression |
Estimated Enrollment: | 20 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF
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Drug: anti-thymocyte globulin (rabbit)
Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF
|
2: Active Comparator
Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF
|
Drug: anti-thymocyte globulin (rabbit)
Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF
|
We will evaluate the therapeutic efficacy of administering Thymoglobulin® induction pre-transplantation in renal allograft recipients. Patients receiving pre-transplant Thymoglobulin will be evaluated for acute rejection (Banff '97 criteria), survival, and safety at 6 months. Overall the use of Thymoglobulin induction pre-transplantation will be safe and effective.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patient who, in the opinion of the investigator, has significant medical or psychosocial problems or unstable disease states that would preclude participation in the study. Examples of significant problems include, but are not limited to, morbid obesity or severe cardiac disease.
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United States, Ohio | |
The Christ Hospital | Recruiting |
Cincinnati, Ohio, United States, 45219 | |
Contact: Adele Rike, PharmD 513-585-2145 | |
Principal Investigator: Adele Rike, PharmD | |
Principal Investigator: E. Steve Woodle, MD |
Principal Investigator: | E. Steve Woodle, MD | University of Cincinnati |
Principal Investigator: | Adele Rike, PharmD | The Christ Hospital |
Responsible Party: | University of Cincinnati ( E. Steve Woodle, MD, FACS ) |
Study ID Numbers: | Pre-Tx Thymo |
Study First Received: | October 10, 2008 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00771745 |
Health Authority: | United States: Institutional Review Board |
Antilymphocyte Serum Mycophenolate mofetil Tacrolimus |
Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |