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| Sponsor: | Medical University Innsbruck |
|---|---|
| Collaborator: |
Astellas Pharma GmbH |
| Information provided by: | Medical University Innsbruck |
| ClinicalTrials.gov Identifier: | NCT00316810 |
Purpose
The purpose of this study is to determine and compare the efficacy of Campath-1H/Tacrolimus versus ATG/Tacrolimus/MMF therapy in conjunction with initial short-term steroids in Type 1-diabetic patients undergoing simultaneous pancreas-kidney allograft transplantation as well as to evaluate the safety of Campath-1H/Tacrolimus versus ATG/Tacrolimus/MMF in terms of drug-related complications and immunosuppression-associated complications.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreas-Kidney Transplantation |
Drug: Alemtuzumab (drug) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | An Open-Label, Randomized, Prospective Study to Investigate the Safety and Efficacy of Campath-1H as an Induction Agent in Combination With Tacrolimus Monotherapy Compared to Short-Course ATG-Induction in Combination With Tacrolimus, Mycophenolate Mofetil and Short-Term Steroids Application in De Novo SPK Transplanted Diabetic Patients |
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | April 2009 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Raimund Margreiter, Prof. Dr. | +43 512 504 ext 22600 | raimund.margreiter@uibk.ac.at |
| Contact: Claudia Boesmueller, Dr. | +43 512 504 ext 81009 | claudia.boesmueller@uibk.ac.at |
| Austria | |
| University Hospital Innsbruck | |
| Innsbruck, Austria, 6020 | |
| Principal Investigator: | Raimund Margreiter, Prof. Dr. | University Hospital Innsbruck, Dept. of General- and Transplant Surgery, Anichstrasse 35, A-6020 Innsbruck |
More Information
| Study ID Numbers: | SIMPATICO, EudraCT number: 2006-000845-21 |
| Study First Received: | April 19, 2006 |
| Last Updated: | April 19, 2006 |
| ClinicalTrials.gov Identifier: | NCT00316810 History of Changes |
| Health Authority: | Austria: Federal Ministry for Health and Women |
|
Campath 1H Alemtuzumab Tacrolimus |
Pancreas-kidney transplantation immunosuppression prevention of acute rejection |
|
Immunologic Factors Antineoplastic Agents Therapeutic Uses Alemtuzumab |
Physiological Effects of Drugs Tacrolimus Immunosuppressive Agents Pharmacologic Actions |