Desensitization for Highly Sensitized Recipients of Pancreas Transplantation

NCT00867386 | Completed

• 2 other identifiers: STU 14940CNV0058087
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Rejection of Pancreas Transplant; Desensitization

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Patient and graft survival.

  Patient and graft survival will be calculated at this time.

  At 12 Month follow-up

Secondary Outcomes (3)

• Tracking infection risks

  Standard of care benchmarks through 12 months

• Bleeding complications

  At 12 Months follow-up time points

• Reversal or halting of diabetic complications

  0, 6, 12, 18, 24 Months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

• 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).

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Xunrong Luo, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Medicine-Nephrology, Microbiology-Immunology and Surgery-Organ Transplantation

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 23, 2009
• Study Start: December 1, 2006
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

US (1)