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Sponsored by: |
Northwestern University |
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Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00166712 |
This is an open label, single-center, randomized phase IV pilot study of steroid and calcineurin inhibitor avoidance in renal transplant recipients. All patients will receive two doses of alemtuzumab (Campath-1H, 30mg); one at the time of renal transplant, and one on post-operative day two to achieve peripheral T-cell depletion. Intravenous glucocorticoids will be administered prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody, and continued for the first two days post-transplant. Thereafter, steroids will not be used for immunosuppression. All transplant recipients will be started on oral immunosuppressive therapy with mycophenolate mofetil (MMF) prior to transplant. Pretransplant, these patients will be randomized to receive, in addition, either tacrolimus (TAC) or sirolimus. After six months, patients in the tacrolimus arm who do not experience rejection will be randomized to continue on tacrolimus or to be converted to the combination of sirolimus and MMF. Individuals in this arm of the study who do not experience acute rejection, and demonstrate evidence of donor specific hyporesponsiveness at 9 months post-transplant (those staying on Tac + MMF) or 3 months post-conversion (those converted from Tac + MMF to sirolimus + MMF) will be weaned to MMF monotherapy.
Individuals in the sirolimus + MMF arm who do not experience acute rejection and demonstrate evidence of donor specific hyporesponsiveness at 6 months post-transplant will be weaned to MMF monotherapy.
Condition | Intervention | Phase |
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Kidney Transplantation |
Drug: Prograf Drug: Rapamune Drug: Campath Drug: Cellcept |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase IV, Single Center Pilot Study Using Alemtuzumab (Campath-1H) Induction Combined With Prednisone-Free, Calcineurin-Inhibitor-Free Immunosuppression in Kidney Transplantation |
Estimated Enrollment: | 75 |
Study Start Date: | April 2005 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Significant cardiovascular disease (e.g.):
Contact: Nancy K Crnkovich, RN, MSN | (312) 503-1056 | n-crnkovich@northwestern.edu |
Contact: Patrice Al-Saden, RN, CCRC | (312) 503-1058 | palsaden@northwestern.edi |
United States, Illinois | |
Northwestern University/Northwestern Memorial Hospital | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Nancy K Crnkovich, RN, MSN 312-503-1056 n-crnkovich@northwestern.edu |
Principal Investigator: | Joseph R Leventhal, MD, PhD | Northwestern University |
Study ID Numbers: | CEL220 |
Study First Received: | September 9, 2005 |
Last Updated: | August 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00166712 |
Health Authority: | United States: Institutional Review Board |
Kidney Transplant Living Donor Kidney Transplant Recipients |
Sirolimus Prednisone Alemtuzumab Mycophenolate mofetil Tacrolimus |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |