Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss
- Conditions
- Type 1 Diabetes Mellitus
- Registration Number
- NCT02000687
- Lead Sponsor
- Rodolfo Alejandro
- Brief Summary
This is a single-center, prospective, open label study in islet transplant recipients following islet graft loss.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- History of at least one islet alone transplant (ie islet transplant in the absence of any other organ transplant).
- Inability to provide written informed consent.
- Mentally unstable and/or unable to comply with the procedures of the study protocol.
- History of any solid organ transplant.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method determine the rate of allosensitization in patients after failed islet transplantation 10 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Diabetes Research Institute
🇺🇸Miami, Florida, United States