Clinical trial NCT00867386: Desensitization for Highly Sensitized Recipients of Pancreas Transplantation
Official title: Desensitization for Highly Sensitized Recipients of Pancreas Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Rejection of Pancreas Transplant
Desensitization
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-03-23
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of type 1 diabetes who are highly sensitized (defined as having panel reactive antibody (PRA) level \>50%) who underwent successful desensitization treatment followed by a deceased donor pancreas transplantation at NMH .

Brief 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

Eligibility criteria: Inclusion Criteria:

* Pancreas transplant recipients with elevated panel reactive antibody levels of \>50% and who have received desensitization treatment and subsequently receive their transplantation at Northwestern Memorial Hospital (NMH).

Exclusion Criteria:

* No Exclusion criteria exist.

Primary outcomes:
measure: Success of surgical engraftment.
timeFrame: Post-operative day 1
measure: Track the improvement of glycemic control.
timeFrame: Standard-of-care labs throughout duration of study
measure: Rejection free graft survival.
timeFrame: 12 Month follow-up from baseline
measure: Patient and graft survival.
timeFrame: At 12 Month follow-up
Secondary outcomes:
measure: Tracking infection risks
timeFrame: Standard of care benchmarks through 12 months
measure: Bleeding complications
timeFrame: At 12 Months follow-up time points
measure: Reversal or halting of diabetic complications
timeFrame: 0, 6, 12, 18, 24 Months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Xunrong Luo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: