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This is a single-center, prospective, open label study in islet transplant recipients following islet graft loss.
Full 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 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.
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There are currently no registered sites for this trial.
Start date
Dec 01, 2008 • 16 years ago
Today
Jan 20, 2025
End date
Dec 01, 2026 • in 1 year and 10 months
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Data sourced from clinicaltrials.gov
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