Comparative Pancreas Induction Study.
Completed
- Conditions
- De novo simultaneous pancreas and kidney transplant recipients.
- Registration Number
- NL-OMON28922
- Lead Sponsor
- Roche, Fresenius
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. Type 1 diabetics (C-peptide negative) with (pre)terminal or end-stage renal failure scheduled to receive a simultaneous pancreas kidney cadaveric transplantation, with either bladder or enteric drainage;
Exclusion Criteria
1. Pancreas after kidney transplant (PAK), pancreas transplant alone (PTA), segmental pancreatic transplant;
2. Duct occlusion technique;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The prevention of biopsy proven early graft rejection and steroid-resistant rejection episodes in the first 6 months after simultaneous pancreas kidney transplantation.
- Secondary Outcome Measures
Name Time Method 1. Recurrence of autoimmune disease parameters;<br /><br>2. Time to first rejection, time after last prophylactic dose and number of steroid-resistant rejection episodes at 3 and 6 months after transplantation;<br /><br>3. Graft and patient survival;<br /><br>4. Immunophenotyping peripheral blood lymphocytes (CD3, CD4, CD8 and CD25 respectively);<br /><br>5. Adverse events and opportunistic infections;<br /><br>6. After the first year patient and graft survival and the occurrence of graft dysfunction will be monitored and documented according to local practice.