Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

Rodolfo Alejandro

Status: Enrolling

Conditions: Type 1 Diabetes Mellitus

Study type: Observational

Funder types: Other

Identifiers

NCT02000687

20080127

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.