Type 1 Diabetes Clinical Trial
Official title:
Desensitization for Highly Sensitized Recipients of Pancreas Transplantation
Verified date | March 2014 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 7 |
Est. completion date | October 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success of surgical engraftment. | This is measured by standard blood flow perfusion scan. Adequate blood flow is demonstrated by appropriate radioactive tracer uptake by the pancreas allograft. Lack of blood flow will prompt immediate surgical intervention. | Post-operative day 1 | Yes |
Primary | Track the improvement of glycemic control. | Standard of care laboratory values measured routinely include: fasting and post-prandial glucose determination, serum C-peptide levels, improvement of Hemoglobin (A1C) levels post-transplant. | Standard-of-care labs throughout duration of study | Yes |
Primary | Rejection free graft survival. | Serum amylase & lipase measured. Rising levels/aberrant glycemic control may indicate allograft rejection. Treatment - pancreas allograft rejection: 1) diagnosed by pancreas allograft biopsy; 2) if rejection, staining for C4d, repeat to DSA to determine rejection (acute antibody meditated humoral vs. acute cellular); 3) acute humoral rejection treated w/plasma exchange, then by Intravenous Immunoglobulin (IVIg) (0.5 gm/kg) every other day, daily polyclonal anti-thymocyte globulin (ATG) at 1.25 mg/kg. Treatment duration based on clinical response. Baseline immunosuppressive medications maintained during treatment. | 12 Month follow-up from baseline | Yes |
Primary | Patient and graft survival. | Patient and graft survival will be calculated at this time. | At 12 Month follow-up | Yes |
Secondary | Tracking infection risks | Screening for viral infections will be performed according to standard of care protocol. Asymptomatic or symptomatic Cytomegalovirus (CMV) viremia will be treated in consultation with Transplant Infectious Diseases Services. Testing for bacterial and fungal infections will be guided by clinical suspicion. Active infection will again be treated in consultation with the Transplant Infectious Diseases Service. | Standard of care benchmarks through 12 months | Yes |
Secondary | Bleeding complications | Though increased risks for bleeding have been associated with repeated plasma exchanges that deplete clotting factors, review to evaluate whether the limited number of plasma exchanges used in the standard of care protocols will show a minimal increase of risks for bleeding. At 12 Month follow-up time points, the number of bleeding episodes, their temporal relation to plasma exchange, and frequency of requirement for factor replacement will be analyzed. | At 12 Months follow-up time points | Yes |
Secondary | Reversal or halting of diabetic complications | For diabetic nephropathy, serum creatinine levels and urine microalbuminuria will be measured. the use of ACE inhibitors, angiotensin receptor blocker, or aldosterone receptor blocker will be noted. For diabetic retinopathy, patients will be referred to an ophthalmologist at the 12 and 24 Months time points to measure diabetic retinal changes based on the Early Treatment Diabetic Retinopathy Study (ETDRS) grading system. | 0, 6, 12, 18, 24 Months | Yes |
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