ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1. Male or female patients, of 18 to 55 years of age, with end-stage, C-peptide-negative, Type 1-diabetic nephropathy.
2. Female patients of childbearing age must have a negative pregnancy test and must agree to maintain effective birth control practice throughout the study period (3 years).
3. Patient must have signed the Patient Informed Consent Form.
4. Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages.
1. Patient is pregnant or breastfeeding.
2. Patient is allergic or intolerant to Mycophenolate Mofetil, Sirolimus, Tacrolimus or
other macrolides, or any compounds structurally related to these compounds.
3. Patient has a positive T-cell crossmatch on the most recent serum specimen.
4. Patient is known for active liver disease or has significant liver disease, defined by
ASAT and ALAT serum levels greater than 3 times the upper limit of normal.
5. Patient has malignancy or history of malignancy, with the exception of adequately
treated localised squamous cell or basal cell carcinoma, without recurrence.
6. Patient has been included in another clinical trial protocol for any investigational
drug within 4 weeks prior to randomisation.
7. Patient has any form of substance abuse, psychiatric disorder or condition, which, in
the opinion of the investigator, may invalidate communication.
8. Patient receives a SPK transplant from a living donor, or receives segmental
pancreatic transplant, or a previous kidney transplant alone.
9. Pancreatic duct occlusion technique .
10. Donor is older than 55 years of age.
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Descriptive Information | ||||
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Brief Title ICMJE | European Trial of Immunosuppression in SPK Tx | |||
Official Title ICMJE | A European Multicenter Open-Label Randomised Trial to Evaluate the Efficacy and Safety of Sirolimus and Tacrolimus Compared to MMF and Tacrolimus With Short-Course Induction Therapy, Short-Term Steroids Application in De Novo SPK Transplanted Diabetic Patients | |||
Brief Summary |
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Detailed Description | This will be a controlled, randomised study, to be performed in 15-20 pancreas transplantation centers throughout Europe. Patients will be randomised into one of two treatment groups. Group 1 will receive Tacrolimus and Mycophenolate Mofetil (= best group in EuroSPK001 trial). Group 2 will receive Tacrolimus and Sirolimus. Both groups will receive in association short-term corticosteroids and polyclonal antibody preparation. Patients will be randomly assigned to one of the 2 treatment groups in a 1:1 ratio before transplantation. The study will last 3 years, with a first interim analysis of the data at 6 months and a complete analysis at 1 year. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: sirolimus versus mycophenolate mofetil | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Enrollment ICMJE | 228 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | April 2008 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria, Belgium, Czech Republic, Germany, Israel, Spain, Switzerland | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00140543 | |||
Other Study ID Numbers ICMJE | EUROSPK002 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | EUROSPK Study Group | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | EUROSPK Study Group | |||
Verification Date | August 2005 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |