Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Type 1 Diabetes Mellitus
- Type
- Observational
- Design
- Observational Model: OtherTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
After complete islet graft loss is determined, patient's maintenance immunosuppression (i.e. sirolimus, tacrolimus, MMF and/or Myfortic®) will be discontinued and they will be monitored for 10 years thereafter, for the appearance of allosensitization using panel reactive antibody (PRA) levels and mo...
After complete islet graft loss is determined, patient's maintenance immunosuppression (i.e. sirolimus, tacrolimus, MMF and/or Myfortic®) will be discontinued and they will be monitored for 10 years thereafter, for the appearance of allosensitization using panel reactive antibody (PRA) levels and monitor the persistence of elevated PRA levels. Primary objective is to determine the rate of allosensitization in patients 3 years after failed islet transplantation (i.e. stimulated c-peptide <0.3mg/mL) and monitor the persistence of elevated PRA levels (≥ 20%) at year 3, 6, and 9. Timing, frequency and level of change in PRA will be monitored after all immunosuppression is discontinued.
Tracking Information
- NCT #
- NCT02000687
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Rodolfo Alejandro, MD University of Miami
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