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Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss
NCT02000687 · University of Miami
In plain English
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About this study
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.
Eligibility criteria
Inclusion Criteria:
1\. History of at least one islet alone transplant (ie islet transplant in the absence of any other organ transplant).
Exclusion Criteria:
1. Inability to provide written informed consent.
2. Mentally unstable and/or unable to comply with the procedures of the study protocol.
3. History of any solid organ transplant.
Study design
Enrollment target: 60 participants
Age groups: adult, older_adult
Timeline
Starts: 2008-12
Estimated completion: 2028-07
Last updated: 2026-03-23
Primary outcomes
- • determine the rate of allosensitization in patients after failed islet transplantation (10 years)
Sponsor
Rodolfo Alejandro · other
Contacts & investigators
InvestigatorRodolfo Alejandro, MD · principal_investigator, University of Miami
All locations (1)
Diabetes Research InstituteRecruiting
Miami, Florida, United States