NCT00867386

Desensitization for Highly Sensitized Recipients of Pancreas Transplantation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an observational study for patients with type 1 diabetes, whom are already scheduled to have desensitization treatment to help increase the chance of receiving a pancreas transplant.The study staff will be looking at medical records in order to collect past, present and future information for each subject's medical condition and/or transplant. There are no additional study tests, procedures or devices needed for our analysis.

Detailed description

Please note that this study is observational. The treatment of each patient will be at the discretion of the care physician. The study investigators will ONLY be performing data collection and analysis. Post transplant all patients will receive one additional cycle of plasma exchange with a moderate dose of Intravenous Immunoglobulin (IVIg) (0.4 mg/Kg). Antibody titers will be monitoring prior to plasma exchange and immediately following the treatment. At this point, since donor antigens are known, only antibodies to these antigens will be tested to minimize cost. We anticipate that in some patients, especially if the original titer of donor-specific antibody (DSA) was high (\> 1:128), a rise in DSA will be observed following transplant. If indeed DSA will be present, additional monitoring will be initiated and the patient will be treated further with plasma exchange/IVIg cycles, with antibody monitoring before and immediately after each cycle. If no DSA are detected, patients will be monitoring on a every other day schedule for the first week; weekly for the next 3 weeks and monthly up to 6 months post transplant. Additional testing will be performed in the event of any clinical evidence of graft dysfunction, or following sever infection events. Patient will be followed to 12 month post transplant or until one of the end points is reached: 1. pancreas graft failure: defined by return of hyperglycemia and resume of insulin therapy; 2. patient death due to all causes with functioning graft

Conditions

• Type 1 Diabetes
• Rejection of Pancreas Transplant
• Desensitization

Timeline

• Start date: 2006-12-01
• Primary completion: 2013-07-01
• Completion: 2013-10-01
• First posted: 2009-03-23
• Last updated: 2014-03-13

Locations

1 site across 1 country: United States