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Desensitization for Highly Sensitized Recipients of Pancreas Transplantation
This study is currently recruiting participants.
Verified by Northwestern University, March 2009
First Received: March 19, 2009   No Changes Posted
Sponsored by: Northwestern University
Information provided by: Northwestern University
ClinicalTrials.gov Identifier: NCT00867386
  Purpose

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
Type 1 Diabetes
Pancreas Transplant
Desensitization

MedlinePlus related topics: Diabetes Diabetes Type 1 Pancreas Transplantation
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Desensitization for Highly Sensitized Recipients of Pancreas Transplantation

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Success of surgical engraftment.
  • Improvement of glycemic control.
  • Rejection free graft survival.
  • Patient and graft survival.

Secondary Outcome Measures:
  • Infection risks
  • Bleeding complications
  • Reversal or halting of diabetic complications

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 10
Study Start Date: December 2006
Estimated Study Completion Date: November 2009
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 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:

  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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 .

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 between January 1, 2007 to December 31, 2008 at NMH.

Exclusion Criteria:

  • No Exclusion criteria exist.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867386

Contacts
Contact: Elyse Stuart, RN 312-503-1060 e-stuart@northwestern.edu

Locations
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Xunrong Luo, MD, PhD Northwestern University
  More Information

No publications provided

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

Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Pancrelipase
Metabolic Disorder

Additional relevant MeSH terms:
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009