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Sponsored by: |
Northwestern University |
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Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00867386 |
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.
Condition |
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Type 1 Diabetes Pancreas Transplant Desensitization |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Desensitization for Highly Sensitized Recipients of Pancreas Transplantation |
Estimated Enrollment: | 10 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | November 2009 |
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 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 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:
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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 .
Inclusion Criteria:
Exclusion Criteria:
Contact: Elyse Stuart, RN | 312-503-1060 | e-stuart@northwestern.edu |
United States, Illinois | |
Northwestern Memorial Hospital | Recruiting |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Xunrong Luo, MD, PhD | Northwestern University |
Responsible Party: | Northwestern University ( Xunrong Luo, MD, PhD ) |
Study ID Numbers: | 1888-004 |
Study First Received: | March 19, 2009 |
Last Updated: | March 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00867386 History of Changes |
Health Authority: | United States: Institutional Review Board |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Pancrelipase Metabolic Disorder |
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |